Trial Outcomes & Findings for Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study) (NCT NCT00773734)

Results Overview

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

352 participants

Primary outcome timeframe

Week 0 and Week 16

Results posted on

2020-05-07

Participant Flow

The study consisted of a 16-week randomized, double-blind, placebo-controlled phase, and a 8-week active treatment phase. At Week 24, subjects may have continued on active treatment by entering a 28-week extension study, total = 52 weeks; At completion of the extension study, subjects may have entered in a long term extension (LTE) for 5 + years.

Time gaps between the end of one study phase and start of the next phase precluded the continuation of some of the participants in the study.

Participant milestones

Participant milestones
Measure	Placebo Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	Placebo-Apremilast 20mg BID Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.	Placebo-Apremilast 30 mg BID Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
Core: Placebo Controlled Phase Week 0-16 STARTED	88	89	87	88	0	0
Core: Placebo Controlled Phase Week 0-16 COMPLETED	72	79	66	70	0	0
Core: Placebo Controlled Phase Week 0-16 NOT COMPLETED	16	10	21	18	0	0
Core: Active Treatment Phase Week 16-24 STARTED	0	77	66	67	34	36
Core: Active Treatment Phase Week 16-24 COMPLETED	0	65	59	65	33	31
Core: Active Treatment Phase Week 16-24 NOT COMPLETED	0	12	7	2	1	5
Extension: Active Treatment Week 24-52 STARTED	0	47	50	58	27	27
Extension: Active Treatment Week 24-52 Completed Extension and Continued LTE	0	5	10	10	4	4
Extension: Active Treatment Week 24-52 COMPLETED	0	34	33	48	22	19
Extension: Active Treatment Week 24-52 NOT COMPLETED	0	13	17	10	5	8
LTE Period: Week 52 to 6 Years STARTED	0	0	16	17	0	0
LTE Period: Week 52 to 6 Years COMPLETED	0	0	4	5	0	0
LTE Period: Week 52 to 6 Years NOT COMPLETED	0	0	12	12	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	Placebo-Apremilast 20mg BID Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.	Placebo-Apremilast 30 mg BID Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
Core: Placebo Controlled Phase Week 0-16 Adverse Event	5	1	8	10	0	0
Core: Placebo Controlled Phase Week 0-16 Lack of Efficacy	4	3	2	2	0	0
Core: Placebo Controlled Phase Week 0-16 Withdrawal by Subject	2	2	6	4	0	0
Core: Placebo Controlled Phase Week 0-16 Death	1	0	0	0	0	0
Core: Placebo Controlled Phase Week 0-16 Lost to Follow-up	2	0	0	1	0	0
Core: Placebo Controlled Phase Week 0-16 Protocol Violation	1	3	4	0	0	0
Core: Placebo Controlled Phase Week 0-16 Other	1	1	1	1	0	0
Core: Active Treatment Phase Week 16-24 Adverse Event	0	4	0	0	1	2
Core: Active Treatment Phase Week 16-24 Lack of Efficacy	0	4	4	1	0	0
Core: Active Treatment Phase Week 16-24 Withdrawal by Subject	0	1	1	0	0	2
Core: Active Treatment Phase Week 16-24 Lost to Follow-up	0	1	1	0	0	0
Core: Active Treatment Phase Week 16-24 Protocol Violation	0	1	1	1	0	1
Core: Active Treatment Phase Week 16-24 Other	0	1	0	0	0	0
Extension: Active Treatment Week 24-52 Adverse Event	0	0	0	0	2	1
Extension: Active Treatment Week 24-52 Lack of Efficacy	0	8	10	3	1	2
Extension: Active Treatment Week 24-52 Withdrawal by Subject	0	3	1	2	2	3
Extension: Active Treatment Week 24-52 Lost to Follow-up	0	2	5	3	0	1
Extension: Active Treatment Week 24-52 Other	0	0	1	2	0	1
LTE Period: Week 52 to 6 Years Adverse Event	0	0	0	1	0	0
LTE Period: Week 52 to 6 Years Lack of Efficacy	0	0	2	4	0	0
LTE Period: Week 52 to 6 Years Withdrawal by Subject	0	0	6	3	0	0
LTE Period: Week 52 to 6 Years Lost to Follow-up	0	0	4	4	0	0

Baseline Characteristics

Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=88 Participants Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 10mg BID n=89 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	Total n=352 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 13.68 • n=5 Participants	44.4 years STANDARD_DEVIATION 13.96 • n=7 Participants	44.6 years STANDARD_DEVIATION 12.62 • n=5 Participants	44.1 years STANDARD_DEVIATION 14.67 • n=4 Participants	44.3 years STANDARD_DEVIATION 13.70 • n=21 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	26 Participants n=7 Participants	32 Participants n=5 Participants	38 Participants n=4 Participants	131 Participants n=21 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	63 Participants n=7 Participants	55 Participants n=5 Participants	50 Participants n=4 Participants	221 Participants n=21 Participants
Race/Ethnicity, Customized White	83 participants n=5 Participants	82 participants n=7 Participants	82 participants n=5 Participants	80 participants n=4 Participants	327 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	13 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islanders	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Duration of Plaque Psoriasis	19.61 years STANDARD_DEVIATION 11.632 • n=5 Participants	18.01 years STANDARD_DEVIATION 12.366 • n=7 Participants	19.51 years STANDARD_DEVIATION 12.151 • n=5 Participants	19.18 years STANDARD_DEVIATION 12.015 • n=4 Participants	18.99 years STANDARD_DEVIATION 12.004 • n=21 Participants

PRIMARY outcome

Timeframe: Week 0 and Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=88 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=89 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16	5.7 percentage of participants	11.2 percentage of participants	28.7 percentage of participants	40.9 percentage of participants	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=89 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24	18.0 percentage of participants Interval 10.6 to 27.5	26.4 percentage of participants Interval 17.6 to 37.0	39.8 percentage of participants Interval 29.5 to 50.8	41.2 percentage of participants Interval 24.6 to 59.3	44.4 percentage of participants Interval 27.9 to 61.9

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=88 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=89 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16	25.0 percentage of participants	38.2 percentage of participants	47.1 percentage of participants	60.2 percentage of participants	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=89 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24	38.2 percentage of participants Interval 28.1 to 49.1	49.4 percentage of participants Interval 38.5 to 60.4	65.9 percentage of participants Interval 55.0 to 75.7	61.8 percentage of participants Interval 43.6 to 77.8	75.0 percentage of participants Interval 57.8 to 87.9

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=88 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=89 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16	1.1 percentage of participants	4.5 percentage of participants	9.2 percentage of participants	11.4 percentage of participants	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=89 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24	4.5 percentage of participants Interval 1.2 to 11.1	8.0 percentage of participants Interval 3.3 to 15.9	14.8 percentage of participants Interval 8.1 to 23.9	14.7 percentage of participants Interval 5.0 to 31.1	16.7 percentage of participants Interval 6.4 to 32.8

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The PASI 100 was not defined and analyzed since there were too few such participants.

A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: The PASI 100 was not defined and analyzed since there were too few such participants.

A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 0 to 16

Population: Time to achieve PASI 100 was not defined or analyzed as there were too few participants.

For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.

Outcome measures

Outcome measures
Measure	Placebo BID n=88 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=82 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percent Change From Baseline in PASI Score at Week 16	-20.3 Percent change Standard Error 3.98	-34.0 Percent change Standard Error 4.00	-45.4 Percent change Standard Error 4.12	-53.2 Percent change Standard Error 4.00	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=87 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=82 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percent Change From Baseline in PASI Score at Week 24	-36.3 percent change Standard Deviation 36.03	-46.5 percent change Standard Deviation 36.08	-56.8 percent change Standard Deviation 34.99	-61.7 percent change Standard Deviation 25.35	-61.7 percent change Standard Deviation 32.67

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.

Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.

Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=88 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=82 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase	-8.0 percent change Standard Error 4.58	-28.3 percent change Standard Error 4.60	-38.0 percent change Standard Error 4.74	-50.4 percent change Standard Error 4.63	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=87 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=82 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24	-28.1 percent change Standard Deviation 46.78	-40.6 percent change Standard Deviation 43.71	-54.0 percent change Standard Deviation 37.32	-52.5 percent change Standard Deviation 37.35	-54.2 percent change Standard Deviation 42.08

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=83 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=78 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=83 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	-1.9 units on a scale Standard Error 0.63	-3.2 units on a scale Standard Error 0.62	-5.9 units on a scale Standard Error 0.65	-4.4 units on a scale Standard Error 0.63	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=87 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=78 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=83 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24	-3.4 units on a scale Standard Deviation 6.40	-6.2 units on a scale Standard Deviation 6.53	-4.9 units on a scale Standard Deviation 5.18	-6.4 units on a scale Standard Deviation 6.64	-5.4 units on a scale Standard Deviation 5.32

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=83 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=78 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=84 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16	-0.6 units on a scale Standard Error 0.89	2.8 units on a scale Standard Error 0.87	2.9 units on a scale Standard Error 0.92	3.0 units on a scale Standard Error 0.89	—

SECONDARY outcome

Timeframe: Week 0 to week 16

Population: The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=83 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=78 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=84 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16	0.7 units on a scale Standard Error 0.80	1.3 units on a scale Standard Error 0.78	2.1 units on a scale Standard Error 0.83	0.8 units on a scale Standard Error 0.80	—

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=87 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=78 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=84 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24	2.8 units on a scale Standard Deviation 9.16	3.9 units on a scale Standard Deviation 9.56	2.9 units on a scale Standard Deviation 10.22	2.8 units on a scale Standard Deviation 10.96	0.5 units on a scale Standard Deviation 9.17

SECONDARY outcome

Timeframe: Week 0 to Week 24

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=87 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=78 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=84 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24	1.1 units on a scale Standard Deviation 6.42	2.3 units on a scale Standard Deviation 8.29	1.0 units on a scale Standard Deviation 7.72	2.5 units on a scale Standard Deviation 9.34	2.7 units on a scale Standard Deviation 8.24

SECONDARY outcome

Timeframe: Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast

Population: Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo

Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.

Outcome measures

Outcome measures
Measure	Placebo BID n=7 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=5 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=3 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)	1008 ng*h/mL Geometric Coefficient of Variation 35.8	1591 ng*h/mL Geometric Coefficient of Variation 56.9	3467 ng*h/mL Geometric Coefficient of Variation 20.8	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.

Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=3 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)	1200 ng*h/mL Geometric Coefficient of Variation 44.6	1257 ng*h/mL Geometric Coefficient of Variation 47.1	3477 ng*h/mL Geometric Coefficient of Variation 29.3	—	—

SECONDARY outcome

Timeframe: Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast

Population: Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo

The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)

Outcome measures

Outcome measures
Measure	Placebo BID n=7 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=5 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=3 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast	209 ng/mL Geometric Coefficient of Variation 27.9	298 ng/mL Geometric Coefficient of Variation 48.3	637 ng/mL Geometric Coefficient of Variation 18.7	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.

The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=3 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast	238 ng/mL Geometric Coefficient of Variation 45.2	236 ng/mL Geometric Coefficient of Variation 39.7	670 ng/mL Geometric Coefficient of Variation 20.4	—	—

SECONDARY outcome

Timeframe: Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast

Population: Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo

Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)

Outcome measures

Outcome measures
Measure	Placebo BID n=7 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=5 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=3 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 1.0 to 4.0	1.00 hours Interval 1.0 to 2.0	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo

Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=3 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)	1.00 hours Interval 1.0 to 3.0	1.50 hours Interval 1.0 to 4.0	1.00 hours Interval 0.5 to 1.0	—	—

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study; LOCF was used.

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52	14.9 percentage of participants Interval 6.2 to 28.3	22.0 percentage of participants Interval 11.5 to 36.0	36.2 percentage of participants Interval 24.0 to 49.0	37.0 percentage of participants Interval 19.4 to 57.6	33.3 percentage of participants Interval 16.5 to 54.0

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32	27.7 percentage of participants Interval 15.6 to 42.6	38.0 percentage of participants Interval 24.7 to 52.8	46.6 percentage of participants Interval 33.3 to 60.1	33.3 percentage of participants Interval 16.5 to 54.0	55.6 percentage of participants Interval 35.3 to 74.5

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40	21.3 percentage of participants Interval 10.7 to 35.7	28.0 percentage of participants Interval 16.2 to 42.5	34.5 percentage of participants Interval 22.5 to 48.1	37.0 percentage of participants Interval 19.4 to 57.6	44.4 percentage of participants Interval 25.5 to 64.7

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32	57.4 percentage of participants Interval 42.2 to 71.7	72.0 percentage of participants Interval 57.5 to 83.8	86.2 percentage of participants Interval 74.6 to 93.9	74.1 percentage of participants Interval 53.7 to 88.9	74.1 percentage of participants Interval 53.7 to 88.9

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40	48.9 percentage of participants Interval 34.1 to 63.9	62.0 percentage of participants Interval 47.2 to 75.3	82.8 percentage of participants Interval 70.6 to 91.4	63.0 percentage of participants Interval 42.4 to 80.6	66.7 percentage of participants Interval 46.0 to 83.5

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52	42.6 percentage of participants Interval 28.3 to 57.8	48.0 percentage of participants Interval 33.7 to 62.6	72.4 percentage of participants Interval 59.1 to 83.6	55.6 percentage of participants Interval 35.3 to 74.5	48.1 percentage of participants Interval 28.7 to 68.1

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32	10.6 percentage of participants Interval 3.5 to 23.1	14.0 percentage of participants Interval 5.8 to 26.7	19.0 percentage of participants Interval 9.9 to 31.4	18.5 percentage of participants Interval 6.3 to 38.1	25.9 percentage of participants Interval 11.1 to 46.3

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40	8.5 percentage of participants Interval 2.4 to 20.4	14.0 percentage of participants Interval 5.8 to 26.7	17.2 percentage of participants Interval 8.6 to 29.4	18.5 percentage of participants Interval 6.3 to 38.1	22.2 percentage of participants Interval 8.6 to 42.3

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study; Intent to Treat; Non-responder imputation

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52	4.3 percentage of participants Interval 0.5 to 14.5	10.0 percentage of participants Interval 3.3 to 21.8	13.8 percentage of participants Interval 6.1 to 25.4	14.8 percentage of participants Interval 4.2 to 33.7	11.1 percentage of participants Interval 2.4 to 29.2

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: The PASI 100 was not defined and analyzed since there were too few such participants.

A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: The PASI 100 was not defined and analyzed since there were too few such participants.

A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: The PASI 100 was not defined and analyzed since there were too few such participants.

A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study

For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study

For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Extension study

Population: Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study

For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Extension Study

Population: Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study

For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=43 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=48 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=55 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=26 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=26 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percent Change in PASI Score at Week 32	-51.0 percent change Standard Deviation 34.10	-63.1 percent change Standard Deviation 27.01	-72.7 percent change Standard Deviation 20.97	-64.0 percent change Standard Deviation 25.16	-69.2 percent change Standard Deviation 27.60

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=36 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=40 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=51 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=24 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=21 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percent Change in PASI Score at Week 40	-55.9 percent change Standard Deviation 29.63	-63.3 percent change Standard Deviation 27.26	-71.1 percent change Standard Deviation 18.91	-64.5 percent change Standard Deviation 27.05	-71.7 percent change Standard Deviation 24.53

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=34 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=34 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=49 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=22 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=19 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percent Change in PASI Score at Week 52	-55.1 percent change Standard Deviation 23.50	-58.9 percent change Standard Deviation 30.65	-65.3 percent change Standard Deviation 29.86	-62.7 percent change Standard Deviation 29.49	-62.0 percent change Standard Deviation 28.28

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.

Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.

Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.

Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=43 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=48 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=55 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=26 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=26 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percent Change From Baseline in the Affected BSA at Week 32	-47.1 percent change Standard Deviation 45.62	-65.1 percent change Standard Deviation 30.42	-75.3 percent change Standard Deviation 20.19	-62.6 percent change Standard Deviation 29.48	-66.7 percent change Standard Deviation 34.50

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=36 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=40 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=51 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=24 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=21 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percent Change From Baseline in the Affected BSA at Week 40	-55.4 percent change Standard Deviation 33.33	-65.4 percent change Standard Deviation 27.33	-74.3 percent change Standard Deviation 17.98	-66.2 percent change Standard Deviation 27.19	-68.0 percent change Standard Deviation 32.83

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=34 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=34 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=49 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=22 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=19 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percent Change From Baseline in the Affected BSA at Week 52	-53.1 percent change Standard Deviation 30.33	-58.3 percent change Standard Deviation 48.88	-67.3 percent change Standard Deviation 32.56	-67.4 percent change Standard Deviation 28.29	-64.9 percent change Standard Deviation 31.26

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=43 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=48 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=55 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=26 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=26 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32	-6.5 units on a scale Standard Deviation 6.13	-7.5 units on a scale Standard Deviation 6.20	-6.0 units on a scale Standard Deviation 5.02	-8.1 units on a scale Standard Deviation 7.16	5.5 units on a scale Standard Deviation 5.63

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=36 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=40 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=52 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=23 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=21 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40	-5.5 units on a scale Standard Deviation 6.42	-6.6 units on a scale Standard Deviation 5.92	-6.4 units on a scale Standard Deviation 4.51	-7.1 units on a scale Standard Deviation 7.54	-5.9 units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=34 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=32 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=49 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=21 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=18 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52	-5.8 units on a scale Standard Deviation 7.11	-6.1 units on a scale Standard Deviation 5.14	-5.6 units on a scale Standard Deviation 4.72	-6.8 units on a scale Standard Deviation 7.16	-4.9 units on a scale Standard Deviation 5.05

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=43 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=48 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=54 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=25 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=26 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32	5.2 units on a scale Standard Deviation 9.45	3.8 units on a scale Standard Deviation 8.26	2.9 units on a scale Standard Deviation 7.80	4.6 units on a scale Standard Deviation 11.93	2.8 units on a scale Standard Deviation 9.64

SECONDARY outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=43 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=48 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=54 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=25 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=26 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32	1.4 units on a scale Standard Deviation 5.26	2.6 units on a scale Standard Deviation 6.67	1.8 units on a scale Standard Deviation 7.58	3.1 units on a scale Standard Deviation 9.44	1.5 units on a scale Standard Deviation 8.46

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=36 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=40 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=51 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=24 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=21 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40	5.4 units on a scale Standard Deviation 10.64	4.8 units on a scale Standard Deviation 8.95	1.7 units on a scale Standard Deviation 7.18	2.9 units on a scale Standard Deviation 12.24	3.8 units on a scale Standard Deviation 8.71

SECONDARY outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=36 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=40 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=51 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=24 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=21 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40	-0.2 units on a scale Standard Deviation 8.40	1.6 units on a scale Standard Deviation 7.77	1.7 units on a scale Standard Deviation 7.34	3.2 units on a scale Standard Deviation 10.89	1.8 units on a scale Standard Deviation 6.20

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=34 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=33 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=49 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=21 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=19 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52	5.1 units on a scale Standard Deviation 11.56	4.1 units on a scale Standard Deviation 9.81	2.4 units on a scale Standard Deviation 7.91	4.7 units on a scale Standard Deviation 12.18	3.4 units on a scale Standard Deviation 7.49

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value..

Outcome measures

Outcome measures
Measure	Placebo BID n=34 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=33 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=49 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=21 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=19 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52	1.2 units on a scale Standard Deviation 7.79	1.2 units on a scale Standard Deviation 5.50	2.0 units on a scale Standard Deviation 6.81	3.4 units on a scale Standard Deviation 12.84	0.3 units on a scale Standard Deviation 6.90

SECONDARY outcome

Timeframe: Week 0 to Week 52

Population: The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted

Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to 52

Population: This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase

Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 weeks after the last dose

Population: Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.

Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.

Outcome measures

Outcome measures
Measure	Placebo BID n=17 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=25 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=36 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=14 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=13 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)	NA weeks Interval 4.3 to Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.	NA weeks Interval 4.1 to Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.	NA weeks Interval 4.3 to Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.	NA weeks Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.	5.3 weeks Interval 5.3 to Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.

SECONDARY outcome

Timeframe: Week 0 to Week 16; up to data cut off of 21 July 2011

Population: Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)

An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.

Outcome measures

Outcome measures
Measure	Placebo BID n=88 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=89 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=87 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase Any treatment emergent AE	57 participants	59 participants	67 participants	72 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase Any drug-related TEAE	11 participants	20 participants	23 participants	32 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase Any severe TEAE	3 participants	1 participants	5 participants	5 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase Any serious TEAE	2 participants	0 participants	3 participants	4 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase Any serious drug-related	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase ≥ 1 TEAE leading to drug interruption	4 participants	3 participants	3 participants	6 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase ≥ 1 TEAE leading to drug withdrawal	5 participants	2 participants	8 participants	12 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase ≥ 1 TEAE leading to death	1 participants	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Week 0-88; up to data cut off of 21 July 2011

Population: Includes all participants who were treated with Apremilast

An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.

Outcome measures

Outcome measures
Measure	Placebo BID n=89 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=121 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=124 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any treatment emergent AE	67 participants	97 participants	110 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any drug-related TEAE	23 participants	31 participants	45 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any severe TEAE	3 participants	9 participants	13 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any serious TEAE	1 participants	8 participants	6 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any serious drug-related	0 participants	1 participants	0 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period ≥ 1 TEAE leading to drug interruption	3 participants	11 participants	9 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period ≥ 1 TEAE leading to drug withdrawal	5 participants	11 participants	15 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period ≥ 1 TEAE leading to death	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Week 0 to 16

Population: Includes PASI-50 responders during the placebo controlled phase

For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.

Outcome measures

Outcome measures
Measure	Placebo BID n=28 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=49 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=49 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=59 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase	6.5 weeks Interval 2.1 to 16.9	5.9 weeks Interval 1.9 to 16.7	6.0 weeks Interval 2.1 to 16.4	4.3 weeks Interval 1.9 to 16.7	—

SECONDARY outcome

Timeframe: Weeks 0 to 16

Population: Includes PASI-75 responders during the placebo controlled phase.

For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.

Outcome measures

Outcome measures
Measure	Placebo BID n=9 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=18 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=30 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=43 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase	8.1 weeks Interval 3.9 to 17.1	10.0 weeks Interval 4.0 to 16.0	11.9 weeks Interval 2.1 to 17.0	6.3 weeks Interval 3.7 to 16.7	—

SECONDARY outcome

Timeframe: Weeks 0 to 16

Population: Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.

For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks

Population: Safety population: includes all participants who were treated with Apremilast

An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.

Outcome measures

Outcome measures
Measure	Placebo BID n=89 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=121 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=124 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any treatment emergent AE	67 participants	97 participants	111 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any drug-related TEAE	23 participants	32 participants	46 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any severe TEAE	4 participants	10 participants	14 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any serious TEAE	2 participants	9 participants	6 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period Any serious drug-related	0 participants	1 participants	0 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period ≥ 1 TEAE leading to drug interruption	3 participants	11 participants	10 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period ≥ 1 TEAE leading to drug withdrawal	5 participants	11 participants	16 participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period ≥ 1 TEAE leading to death	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: ITT; participants who entered the long-term extension study

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months	60.0 percentage of participants Interval 14.7 to 94.7	0.0 percentage of participants Interval 0.0 to 60.2	40.0 percentage of participants Interval 12.2 to 73.8	0.0 percentage of participants Interval 0.0 to 60.2	50.0 percentage of participants Interval 18.7 to 81.3

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; participants who entered the long-term extension study

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years	20.0 percentage of participants Interval 0.5 to 71.6	0.0 percentage of participants Interval 0.0 to 60.2	30.0 percentage of participants Interval 6.7 to 65.2	25.0 percentage of participants Interval 0.6 to 80.6	50.0 percentage of participants Interval 18.7 to 81.3

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; Participants who entered the long-term extension period

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years	60.0 percentage of participants Interval 14.7 to 94.7	25.0 percentage of participants Interval 0.6 to 80.6	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 60.2	30.0 percentage of participants Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; Participants who entered the long-term extension period

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years	40.0 percentage of participants Interval 5.3 to 85.3	0.0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 30.8	25.0 percentage of participants Interval 0.6 to 80.6	30.0 percentage of participants Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: ITT; Participants who entered the long-term extension period

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months	100.0 percentage of participants Interval 47.8 to 100.0	50.0 percentage of participants Interval 6.8 to 93.2	70.0 percentage of participants Interval 34.8 to 93.3	50.0 percentage of participants Interval 6.8 to 93.2	100 percentage of participants Interval 69.2 to 100.0

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; Participants who entered the long-term extension period

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years	60.0 percentage of participants Interval 14.7 to 94.7	50.0 percentage of participants Interval 6.8 to 93.2	50.0 percentage of participants Interval 18.7 to 81.3	25.0 percentage of participants Interval 0.6 to 80.6	90.0 percentage of participants Interval 55.5 to 99.7

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; Participants who entered the long-term extension period

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years	60.0 percentage of participants Interval 14.7 to 94.7	50.0 percentage of participants Interval 6.8 to 93.2	30.0 percentage of participants Interval 6.7 to 65.2	50.0 percentage of participants Interval 6.8 to 93.2	60.0 percentage of participants Interval 26.2 to 87.8

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; Participants who entered the long-term extension period

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years	40.0 percentage of participants Interval 5.3 to 85.3	25.0 percentage of participants Interval 0.6 to 80.6	20.0 percentage of participants Interval 2.5 to 55.6	25.0 percentage of participants Interval 0.6 to 80.6	40.0 percentage of participants Interval 12.2 to 73.8

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: ITT; Participants who entered the long-term extension period

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months	0.0 percentage of participants Interval 0.0 to 52.2	0.0 percentage of participants Interval 0.0 to 60.2	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 60.2	30.0 percentage of participants Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; Participants who entered the long-term extension period

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years	0.0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 60.2	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 60.2	30.0 percentage of participants Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; Participants who entered the long-term extension period

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years	20.0 percentage of participants Interval 0.5 to 71.6	0.0 percentage of participants Interval 0.0 to 60.2	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 60.2	20.0 percentage of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; Participants who entered the long-term extension period

PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years	0.0 percentage of participants Interval 0.0 to 52.2	0.0 percentage of participants Interval 0.0 to 60.2	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 60.2	20.0 percentage of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: The PASI 100 was not defined and analyzed since there were too few such participants.

PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: ITT; Participants who entered the long-term extension period

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in PASI Score at 18 Months	-71.8 percent change Standard Deviation 14.84	-60.5 percent change Standard Deviation 9.19	-65.3 percent change Standard Deviation 21.28	-50.0 percent change Standard Deviation 12.83	-77.3 percent change Standard Deviation 17.77

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; Participants who entered the long-term extension period

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=7 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=9 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in PASI Score at 2 Years	-57.8 percent change Standard Deviation 19.51	-64.5 percent change Standard Deviation 3.54	-65.9 percent change Standard Deviation 21.22	-46.0 percent change Standard Deviation 23.11	-78.4 percent change Standard Deviation 16.60

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; Participants who entered the long-term extension period

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=3 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=6 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=6 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in PASI Score at 3 Years	-87.7 percent change Standard Deviation 5.69	-69.0 percent change Standard Deviation 22.63	-48.8 percent change Standard Deviation 29.69	-48.0 percent change Standard Deviation 14.12	-80.0 percent change Standard Deviation 17.88

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; Participants who entered the long-term extension period

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score

Outcome measures

Outcome measures
Measure	Placebo BID n=2 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=2 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=1 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=4 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in PASI Score at 4 Years	-82.5 percent change Standard Deviation 0.71	-52.0 percent change Standard Deviation 29.70	-54.3 percent change Standard Deviation 20.55	-80.0 percent change Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	-85.0 percent change Standard Deviation 17.80

SECONDARY outcome

Timeframe: Week 0 to Week 196

Population: The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.

Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months	-71.1 percent change Standard Deviation 16.82	-73.9 percent change Standard Deviation 1.61	-74.2 percent change Standard Deviation 18.83	-44.2 percent change Standard Deviation 26.79	-76.7 percent change Standard Deviation 23.70

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; participants who entered the long-term extension period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=7 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=9 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years	-64.7 percent change Standard Deviation 15.95	-66.2 percent change Standard Deviation 3.62	-74.5 percent change Standard Deviation 15.86	-24.7 percent change Standard Deviation 49.99	-74.5 percent change Standard Deviation 21.66

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; participants who entered the long-term extension period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=3 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=6 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=6 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years	-86.1 percent change Standard Deviation 3.00	-63.4 percent change Standard Deviation 25.31	-58.4 percent change Standard Deviation 29.80	-39.1 percent change Standard Deviation 39.39	-78.5 percent change Standard Deviation 21.02

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; participants who entered the long-term extension period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=2 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=1 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=4 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years	-75.0 percent change Standard Deviation 0.00	-50.6 percent change Standard Deviation 18.48	-72.4 percent change Standard Deviation 14.95	-75.0 percent change Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	-86.1 percent change Standard Deviation 18.58

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: Intent to Treat; participants who entered into the LTE period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months	-78.6 percent change Interval -83.3 to -42.9	-73.9 percent change Interval -75.0 to -72.7	-73.3 percent change Interval -95.3 to -47.3	-49.2 percent change Interval -69.4 to -9.1	-86.4 percent change Interval -100.0 to -30.8

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: Intent to Treat; participants who entered into the LTE period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=7 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=9 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years	-60.5 percent change Interval -91.7 to -50.0	-66.2 percent change Interval -68.8 to -63.6	-75.0 percent change Interval -95.5 to -56.3	-41.5 percent change Interval -61.1 to 45.5	-77.4 percent change Interval -100.0 to -42.9

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: Intent to Treat; participants who entered into the long-term extension period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=3 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=6 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=6 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years	-85.7 percent change Interval -89.3 to -83.3	-63.4 percent change Interval -81.3 to -45.5	-60.9 percent change Interval -95.5 to -7.7	-52.2 percent change Interval -70.0 to 18.2	-81.0 percent change Interval -100.0 to -50.0

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: Intent to Treat; participants who entered into the LTE period

The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.

Outcome measures

Outcome measures
Measure	Placebo BID n=2 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=1 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=4 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years	-75.0 percent change Interval -75.0 to -75.0	-50.6 percent change Interval -63.6 to -37.5	-73.5 percent change Interval -86.4 to -56.3	-75.0 percent change Interval -75.0 to -75.0	-91.9 percent change Interval -100.0 to -60.7

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: Intent to Treat; Includes participants who entered the long term extension period

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=2 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months	—	—	-6.5 units on a scale Standard Deviation 4.95	—	—

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: Intent to Treat; Includes participants who entered the long term extension study

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=7 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=9 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years	-5.2 units on a scale Standard Deviation 5.17	-13.5 units on a scale Standard Deviation 16.26	-5.9 units on a scale Standard Deviation 5.70	-1.8 units on a scale Standard Deviation 2.36	-6.8 units on a scale Standard Deviation 4.27

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: Intent to Treat; Includes participants who entered the long term extension period

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=3 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=1 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=6 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=6 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years	-11.7 units on a scale Standard Deviation 5.03	-3.0 units on a scale Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	-4.2 units on a scale Standard Deviation 3.37	-2.0 units on a scale Standard Deviation 3.56	-6.0 units on a scale Standard Deviation 6.03

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: Intent to Treat; Includes participants who entered the long term extension study

The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.

Outcome measures

Outcome measures
Measure	Placebo BID n=2 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=1 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=3 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years	-6.0 units on a scale Standard Deviation 5.66	-9.0 units on a scale Standard Deviation 11.31	-3.5 units on a scale Standard Deviation 1.00	-7.0 units on a scale Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	-10.3 units on a scale Standard Deviation 5.13

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: ITT; Includes participants who entered the long term extension period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=2 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months	—	—	-2.8 units on a scale Standard Deviation 15.33	—	—

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; Includes participants who entered the long-term extension period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=7 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=9 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years	5.0 units on a scale Standard Deviation 8.60	2.0 units on a scale Standard Deviation 14.75	5.2 units on a scale Standard Deviation 9.57	4.5 units on a scale Standard Deviation 8.75	0.2 units on a scale Standard Deviation 11.21

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; Includes participants who entered the long-term extension study

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=3 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=1 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=6 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=6 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years	6.0 units on a scale Standard Deviation 8.44	-2.7 units on a scale Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	3.6 units on a scale Standard Deviation 7.91	2.1 units on a scale Standard Deviation 10.79	2.4 units on a scale Standard Deviation 3.75

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; Includes participants who entered the long-term extension period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=2 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=1 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=4 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years	-1.1 units on a scale Standard Deviation 19.83	4.1 units on a scale Standard Deviation 10.07	-1.0 units on a scale Standard Deviation 1.50	17.6 units on a scale Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	1.2 units on a scale Standard Deviation 6.54

SECONDARY outcome

Timeframe: Week 0 to Month 18

Population: ITT; Includes participants who entered the long-term extension study

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=2 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months	—	—	10.2 units on a scale Standard Deviation 11.84	—	—

SECONDARY outcome

Timeframe: Week 0 to Month 24

Population: ITT; Includes participants who entered the long-term extension period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=7 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=9 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years	4.1 units on a scale Standard Deviation 9.15	3.7 units on a scale Standard Deviation 1.87	1.0 units on a scale Standard Deviation 7.13	2.4 units on a scale Standard Deviation 8.07	5.0 units on a scale Standard Deviation 6.33

SECONDARY outcome

Timeframe: Week 0 to Month 36

Population: ITT; Includes participants who entered the long-term extension period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=3 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=1 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=6 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=6 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years	6.6 units on a scale Standard Deviation 9.48	1.0 units on a scale Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	-0.1 units on a scale Standard Deviation 6.05	4.4 units on a scale Standard Deviation 7.49	4.2 units on a scale Standard Deviation 9.27

SECONDARY outcome

Timeframe: Week 0 to Month 48

Population: ITT; Includes participants who entered the long-term extension period

The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Outcome measures

Outcome measures
Measure	Placebo BID n=2 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=2 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=1 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=4 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years	1.4 units on a scale Standard Deviation 16.06	2.0 units on a scale Standard Deviation 0.79	-4.1 units on a scale Standard Deviation 4.95	10.2 units on a scale Standard Deviation NA Standard Deviation is not available because there was only one participant analyzed.	9.4 units on a scale Standard Deviation 6.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Week 16

Population: Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease

Outcome measures

Outcome measures
Measure	Placebo BID n=87 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=86 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=80 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=83 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16	12.6 percentage of participants	10.5 percentage of participants	25.0 percentage of participants	33.7 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 and Week 24

Population: Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease

Outcome measures

Outcome measures
Measure	Placebo BID n=89 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=87 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=88 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=34 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=36 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24	13.5 percentage of participants Interval 7.2 to 22.4	24.1 percentage of participants Interval 15.6 to 34.5	34.1 percentage of participants Interval 24.3 to 45.0	41.2 percentage of participants Interval 24.6 to 59.3	50.0 percentage of participants Interval 32.9 to 67.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Week 32

Population: Includes participants who entered the extension study; Intent to Treat

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32	23.4 percentage of participants Interval 12.3 to 38.0	26 percentage of participants Interval 14.6 to 40.3	44.8 percentage of participants Interval 31.7 to 58.5	33.3 percentage of participants Interval 16.5 to 54.0	59.3 percentage of participants Interval 38.8 to 77.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Week 40

Population: Includes participants who entered the extension study; Intent to Treat

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40	23.4 percentage of participants Interval 12.3 to 38.0	18.0 percentage of participants Interval 8.6 to 31.4	29.3 percentage of participants Interval 18.1 to 42.7	29.6 percentage of participants Interval 13.8 to 50.2	37.0 percentage of participants Interval 19.4 to 57.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Week 52

Population: Includes participants who entered the extension study; LOCF was used.

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.

Outcome measures

Outcome measures
Measure	Placebo BID n=47 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=50 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=58 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=27 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=27 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52	12.8 percentage of participants Interval 4.8 to 25.7	10.0 percentage of participants Interval 3.3 to 21.8	22.4 percentage of participants Interval 12.5 to 35.3	33.3 percentage of participants Interval 16.5 to 54.0	22.2 percentage of participants Interval 8.6 to 42.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Month 18

Population: ITT; Participants who entered the long-term extension period

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months	60.0 percentage of participants Interval 14.7 to 94.7	0.0 percentage of participants Interval 0.0 to 60.2	20.0 percentage of participants Interval 2.5 to 55.6	25.0 percentage of participants Interval 0.6 to 80.6	60.0 percentage of participants Interval 26.2 to 87.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Month 24

Population: ITT; Participants who entered the extension period

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years	20.0 percentage of participants Interval 0.5 to 71.6	0.00 percentage of participants Interval 0.0 to 60.2	10.0 percentage of participants Interval 0.3 to 44.5	25.0 percentage of participants Interval 0.6 to 80.6	40.0 percentage of participants Interval 12.2 to 73.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 and month 36

Population: ITT; Participants who entered the long-term extension period

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years	60.0 percentage of participants Interval 14.7 to 94.7	0.0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 30.8	25.0 percentage of participants Interval 0.6 to 80.6	30.0 percentage of participants Interval 6.7 to 65.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Month 48

Population: ITT; Participants who entered the long-term extension period

The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease

Outcome measures

Outcome measures
Measure	Placebo BID n=5 Participants Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID n=4 Participants Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID n=10 Participants Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.	Apremilast 30 mg BID n=4 Participants Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.	PBO-Apremilast 30 mg BID n=10 Participants Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years	20.0 percentage of participants Interval 0.5 to 71.6	0.0 percentage of participants Interval 0.0 to 60.2	0.0 percentage of participants Interval 0.0 to 30.8	25.0 percentage of participants Interval 0.6 to 80.6	30.0 percentage of participants Interval 6.7 to 65.2

Adverse Events

Placebo (Weeks 0-16)

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Apremilast 10mg BID (Weeks 0-16)

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Apremilast 20mg BID (Weeks 0-16)

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Apremilast 30mg BID (Weeks 0-16)

Serious events: 4 serious events

Other events: 55 other events

Deaths: 0 deaths

Apremilast 10mg BID (APR Exposure Period) Years 0-6

Serious events: 2 serious events

Other events: 52 other events

Deaths: 0 deaths

Apremilast 20mg BID (APR Exposure Period) Years 0-6

Serious events: 9 serious events

Other events: 66 other events

Deaths: 0 deaths

Apremilast 30mg BID (APR Exposure Period) Years 0-6

Serious events: 9 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Weeks 0-16) n=88 participants at risk Participants randomized to placebo PO BID during the Placebo-controlled Phase	Apremilast 10mg BID (Weeks 0-16) n=89 participants at risk Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID (Weeks 0-16) n=87 participants at risk Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 30mg BID (Weeks 0-16) n=88 participants at risk Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID (APR Exposure Period) Years 0-6 n=89 participants at risk Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).	Apremilast 20mg BID (APR Exposure Period) Years 0-6 n=121 participants at risk Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.	Apremilast 30mg BID (APR Exposure Period) Years 0-6 n=124 participants at risk Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
Cardiac disorders Angina pectoris	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Cardiac disorders Myocardial infarction	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.81% 1/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Gastrointestinal disorders Pancreatitis	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
General disorders Oedema peripheral	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
General disorders Sudden death	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Bronchitis	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Cellulitis	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Pneumonia	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.81% 1/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.81% 1/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.6% 2/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Nervous system disorders Headache	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	2.3% 2/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.6% 2/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Psychiatric disorders Anxiety	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Renal and urinary disorders Nephrolithiasis	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.81% 1/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Reproductive system and breast disorders Epididymitis	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.81% 1/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Skin and subcutaneous tissue disorders Drug eruption	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Vascular disorders Hypertension	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.83% 1/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.

Other adverse events

Other adverse events
Measure	Placebo (Weeks 0-16) n=88 participants at risk Participants randomized to placebo PO BID during the Placebo-controlled Phase	Apremilast 10mg BID (Weeks 0-16) n=89 participants at risk Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).	Apremilast 20mg BID (Weeks 0-16) n=87 participants at risk Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 30mg BID (Weeks 0-16) n=88 participants at risk Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)	Apremilast 10mg BID (APR Exposure Period) Years 0-6 n=89 participants at risk Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).	Apremilast 20mg BID (APR Exposure Period) Years 0-6 n=121 participants at risk Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.	Apremilast 30mg BID (APR Exposure Period) Years 0-6 n=124 participants at risk Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
Gastrointestinal disorders Diarrhoea	4.5% 4/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	6.7% 6/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	6.9% 6/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	13.6% 12/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	7.9% 7/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	7.4% 9/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	13.7% 17/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Gastrointestinal disorders Dyspepsia	2.3% 2/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.7% 5/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.5% 4/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.0% 6/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	7.3% 9/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Gastrointestinal disorders Nausea	8.0% 7/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	11.2% 10/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	14.9% 13/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	19.3% 17/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	13.5% 12/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	16.5% 20/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	22.6% 28/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Gastrointestinal disorders Vomiting	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	3.4% 3/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.5% 4/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	6.6% 8/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.0% 5/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Gastroenteritis	3.4% 3/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.6% 4/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.7% 5/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.5% 4/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	6.6% 8/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.6% 7/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Nasopharyngitis	8.0% 7/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	9.0% 8/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	8.0% 7/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.7% 5/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	11.2% 10/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	9.1% 11/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	10.5% 13/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Sinusitis	2.3% 2/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	3.4% 3/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	3.4% 3/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.6% 5/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	2.5% 3/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.8% 6/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Upper respiratory tract infection	4.5% 4/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	10.1% 9/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	12.6% 11/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	15.9% 14/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	15.7% 14/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	15.7% 19/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	20.2% 25/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Infections and infestations Viral upper respiratory tract infection	9.1% 8/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	2.2% 2/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	9.2% 8/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	8.0% 7/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	7.9% 7/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	10.7% 13/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	10.5% 13/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Injury, poisoning and procedural complications Muscle strain	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	2.2% 2/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	2.3% 2/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.6% 5/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.1% 5/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.6% 7/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	6.8% 6/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.1% 1/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.00% 0/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	1.7% 2/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	0.81% 1/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Nervous system disorders Headache	5.7% 5/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	5.6% 5/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	9.2% 8/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	8.0% 7/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	7.9% 7/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	10.7% 13/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	8.9% 11/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.
Nervous system disorders Tension headache	8.0% 7/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	3.4% 3/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	2.3% 2/87 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	15.9% 14/88 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	4.5% 4/89 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	3.3% 4/121 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.	14.5% 18/124 • Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study. Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.

Additional Information

Anne McClain

Celgene Corporation

Phone: 888-243-1360

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Publication restrictions are in place

Restriction type: OTHER