Trial Outcomes & Findings for A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life (NCT NCT03774875)

Results Overview

The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

277 participants

Primary outcome timeframe

Baseline and week 16

Results posted on

2025-07-10

Participant Flow

Eligible participants were enrolled at 55 centers in France, Germany, Italy, Spain, Switzerland, and the United Kingdom. The study consisted of a 16-week placebo-controlled period and a 36-week apremilast extension period.

Participants were randomized in a 1:2 ratio to receive placebo or apremilast. Participants were block-randomized to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations).

Participant milestones

Participant milestones
Measure	Placebo / Apremilast 30 mg Participants received placebo tablets orally twice a day for 16 weeks. At Week 16 participants switched to receive 30 mg apremilast orally twice a day up to week 52.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.
Placebo-controlled Period (Week 1-16) STARTED	92	185
Placebo-controlled Period (Week 1-16) Received Study Drug	91	185
Placebo-controlled Period (Week 1-16) COMPLETED	69	152
Placebo-controlled Period (Week 1-16) NOT COMPLETED	23	33
Apremilast Extension Period (Week 16-52) STARTED	69	152
Apremilast Extension Period (Week 16-52) COMPLETED	53	105
Apremilast Extension Period (Week 16-52) NOT COMPLETED	16	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo / Apremilast 30 mg Participants received placebo tablets orally twice a day for 16 weeks. At Week 16 participants switched to receive 30 mg apremilast orally twice a day up to week 52.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.
Placebo-controlled Period (Week 1-16) Adverse Event	8	16
Placebo-controlled Period (Week 1-16) Lack of Efficacy	2	4
Placebo-controlled Period (Week 1-16) Withdrawal by Subject	12	10
Placebo-controlled Period (Week 1-16) Lost to Follow-up	0	2
Placebo-controlled Period (Week 1-16) Protocol Deviation	0	1
Placebo-controlled Period (Week 1-16) Reason Unknown	1	0
Apremilast Extension Period (Week 16-52) Adverse Event	6	9
Apremilast Extension Period (Week 16-52) Lack of Efficacy	2	11
Apremilast Extension Period (Week 16-52) Withdrawal by Subject	7	20
Apremilast Extension Period (Week 16-52) Non-compliance with Study Drug	0	2
Apremilast Extension Period (Week 16-52) Other	1	1
Apremilast Extension Period (Week 16-52) Protocol Deviation	0	1
Apremilast Extension Period (Week 16-52) Lost to Follow-up	0	3

Baseline Characteristics

A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo / Apremilast 30 mg n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks. At Week 16 participants switched to receive 30 mg apremilast orally twice a day up to week 52.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.	Total n=277 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 13.68 • n=5 Participants	47.4 years STANDARD_DEVIATION 14.28 • n=7 Participants	48.6 years STANDARD_DEVIATION 14.16 • n=5 Participants
Age, Customized < 65 years	73 Participants n=5 Participants	158 Participants n=7 Participants	231 Participants n=5 Participants
Age, Customized ≥ 65 years	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	79 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	106 Participants n=7 Participants	163 Participants n=5 Participants
Race/Ethnicity, Customized White	89 Participants n=5 Participants	179 Participants n=7 Participants	268 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Not Collected or Unknown	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment France	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Germany	45 Participants n=5 Participants	102 Participants n=7 Participants	147 Participants n=5 Participants
Region of Enrollment Italy	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Spain	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment Switzerland	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United Kingdom	9 Participants n=5 Participants	28 Participants n=7 Participants	37 Participants n=5 Participants
Duration of Plaque Psoriasis	18.41 years STANDARD_DEVIATION 13.350 • n=5 Participants	16.31 years STANDARD_DEVIATION 13.116 • n=7 Participants	17.01 years STANDARD_DEVIATION 13.207 • n=5 Participants
Primary Manifestations for Stratifications Scalp Psoriasis	23 Participants n=5 Participants	45 Participants n=7 Participants	68 Participants n=5 Participants
Primary Manifestations for Stratifications Nail Psoriasis	20 Participants n=5 Participants	40 Participants n=7 Participants	60 Participants n=5 Participants
Primary Manifestations for Stratifications Palmoplantar Psoriasis	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Primary Manifestations for Stratifications Genital Psoriasis	15 Participants n=5 Participants	28 Participants n=7 Participants	43 Participants n=5 Participants
Primary Manifestations for Stratifications Psoriasis in Visible Locations	24 Participants n=5 Participants	50 Participants n=7 Participants	74 Participants n=5 Participants
Dermatology Life Quality Index (DLQI) Score	18.5 score on a scale STANDARD_DEVIATION 4.94 • n=5 Participants	18.1 score on a scale STANDARD_DEVIATION 4.86 • n=7 Participants	18.2 score on a scale STANDARD_DEVIATION 4.88 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants; Missing data at week 16 were imputed using multiple imputation.

The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	41.3 percentage of participants Interval 30.0 to 52.6	73.3 percentage of participants Interval 66.7 to 79.9

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants; Missing data at week 16 were imputed using multiple imputation.

The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in DLQI at Week 16	-3.4 score on a scale Standard Error 0.80	-8.7 score on a scale Standard Error 0.54

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants; Missing data at week 16 were imputed using multiple imputation.

Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on 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 n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16	18.5 percent change Standard Error 12.95	-19.8 percent change Standard Error 6.58

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants; Missing data at week 16 were imputed using multiple imputation.

The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'. A negative change from baseline indicates improvement in itch severity.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16	-0.9 score on a scale Standard Error 0.32	-2.5 score on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants; Missing data at week 16 were imputed using multiple imputation.

Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement in skin discomfort/pain.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16	-5.4 score on a scale Standard Error 3.61	-21.5 score on a scale Standard Error 2.36

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants; missing data at week 16 were imputed using multiple imputation.

The PASI score 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. 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). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16	26.3 percentage of participants Interval 16.6 to 36.0	39.7 percentage of participants Interval 32.3 to 47.1

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants; Missing data at week 16 were imputed using multiple imputation.

The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16	39.9 percentage of participants Interval 28.8 to 51.0	76.6 percentage of participants Interval 70.2 to 83.1

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants with available data at baseline and week 16.

EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=160 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16	18.9 percent change Standard Error 15.96	33.8 percent change Standard Error 10.67

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants with available data at baseline and week 16.

EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=160 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percent Change From Baseline in EQ-5D Index Score at Week 16	165.9 percent change Standard Error 89.80	17.8 percent change Standard Error 59.59

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants with available data and who had reported being employed at baseline and at week 16.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=104 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed	-4.1 percent impairment Standard Error 2.56	-0.9 percent impairment Standard Error 1.54

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants with available data and who had reported being employed at baseline and at week 16.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=102 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment	-11.5 percent impairment Standard Error 3.82	-13.9 percent impairment Standard Error 2.32

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants with available data and who had reported being employed at baseline and at week 16.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=104 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment	-13.2 percent impairment Standard Error 4.35	-13.8 percent impairment Standard Error 2.63

SECONDARY outcome

Timeframe: Baseline and week 16

Population: All randomized participants with available data at baseline and at week 16.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=116 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment	-13.4 percent impairment Standard Error 3.66	-21.2 percent impairment Standard Error 2.24

SECONDARY outcome

Timeframe: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.

Population: All randomized participants who received at least one dose of study drug.

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a 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 of a preexisting condition was considered an AE. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=91 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period Any TEAE	54 Participants	152 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period Drug-related TEAE	26 Participants	113 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period Severe TEAEs	1 Participants	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period Serious drug-related TEAE	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period TEAE leading to drug interruption	0 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period TEAE leading to drug withdrawal	8 Participants	18 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period Serious TEAEs	0 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period TEAE leading to death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: All randomized participants who received at least one dose of study drug with at least one post-baseline measurement.

Marked laboratory abnormalities are defined for each parameter below. ULN = upper limit of normal

Outcome measures

Outcome measures
Measure	Placebo n=80 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=162 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Glucose > 13.9 mmol/L	0 Participants	3 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Hemoglobin A1C (Fasting) > 9%	0 Participants	3 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Lactate Dehydrogenase > 3 × ULN	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Potassium < 3.0 mmol/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Potassium > 5.5 mmol/L	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Sodium < 130 mmol/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Sodium > 150 mmol/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Triglycerides > 3.4 mmol/L	6 Participants	6 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Alanine Aminotransferase > 3 × ULN	0 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Albumin < 25 g/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Alkaline Phosphatase > 400 U/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Aspartate Aminotransferase > 3 × ULN	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Bilirubin (umol/L) > 1.8 × ULN	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Blood Urea Nitrogen > 15 mmol/L	0 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Calcium < 1.8 mmol/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Calcium > 3.0 mmol/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Cholesterol > 7.8 mmol/L	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Creatinine > 1.7 × ULN	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Glucose < 2.8 mmol/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Hemoglobin: Female < 85 g/L, Male < 105 g/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Hemoglobin: Female > 170 g/L, Male > 185 g/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Leukocytes < 1.5 × 10^9/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Lymphocytes < 0.8 × 10^9/L	1 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Neutrophils, Segmented < 1.0 × 10^9/L	0 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Platelets < 75 × 10^9/L	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period Platelets > 600 × 10^9/L	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, and week 16

Population: Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=91 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Blood Pressure During the Placebo-controlled Period Systolic: week 2	-0.5 mmHg Standard Deviation 11.17	0.1 mmHg Standard Deviation 12.44
Change From Baseline in Blood Pressure During the Placebo-controlled Period Systolic: week 4	1.9 mmHg Standard Deviation 12.29	0.4 mmHg Standard Deviation 11.88
Change From Baseline in Blood Pressure During the Placebo-controlled Period Systolic: week 16	2.2 mmHg Standard Deviation 13.77	1.0 mmHg Standard Deviation 12.66
Change From Baseline in Blood Pressure During the Placebo-controlled Period Diastolic: week 2	-0.1 mmHg Standard Deviation 7.89	-0.6 mmHg Standard Deviation 8.27
Change From Baseline in Blood Pressure During the Placebo-controlled Period Diastolic: week 4	1.3 mmHg Standard Deviation 7.62	-1.0 mmHg Standard Deviation 9.51
Change From Baseline in Blood Pressure During the Placebo-controlled Period Diastolic: week 16	0.8 mmHg Standard Deviation 8.29	0.6 mmHg Standard Deviation 9.12

SECONDARY outcome

Timeframe: Baseline and week 2, week 4, and week 16

Population: Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=91 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Pulse Rate During the Placebo-controlled Period Week 4	-0.4 beats/minute Standard Deviation 10.17	3.5 beats/minute Standard Deviation 10.43
Change From Baseline in Pulse Rate During the Placebo-controlled Period Week 2	0.3 beats/minute Standard Deviation 10.82	3.4 beats/minute Standard Deviation 9.75
Change From Baseline in Pulse Rate During the Placebo-controlled Period Week 16	1.0 beats/minute Standard Deviation 9.97	2.0 beats/minute Standard Deviation 10.99

SECONDARY outcome

Timeframe: Baseline and week 2, week 4, and week 16

Population: Randomized participants who received at least one dose of study drug and with with a baseline value and a post-baseline value at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=91 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Body Weight During the Placebo-controlled Period Week 2	-0.02 kg Standard Deviation 1.161	-0.31 kg Standard Deviation 1.188
Change From Baseline in Body Weight During the Placebo-controlled Period Week 4	0.04 kg Standard Deviation 1.285	-0.57 kg Standard Deviation 2.060
Change From Baseline in Body Weight During the Placebo-controlled Period Week 16	0.08 kg Standard Deviation 2.337	-0.98 kg Standard Deviation 2.722

SECONDARY outcome

Timeframe: Baseline and week 2, week 4, and week 16

Population: Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=91 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=185 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Waist Circumference During the Placebo-controlled Period Week 2	-0.2 cm Standard Deviation 3.93	0.2 cm Standard Deviation 3.49
Change From Baseline in Waist Circumference During the Placebo-controlled Period Week 4	-0.1 cm Standard Deviation 4.89	-0.3 cm Standard Deviation 3.63
Change From Baseline in Waist Circumference During the Placebo-controlled Period Week 16	0.1 cm Standard Deviation 6.16	-0.9 cm Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline, week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.

The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=152 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52 Week 52	76.8 percentage of participants Interval 65.1 to 86.1	79.6 percentage of participants Interval 72.3 to 85.7
Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52 Week 32	68.1 percentage of participants Interval 55.8 to 78.8	68.4 percentage of participants Interval 60.4 to 75.7

SECONDARY outcome

Timeframe: Baseline, week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and each time point

The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=152 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in DLQI at Weeks 32 and 52 Week 32	-9.8 score on a scale Standard Deviation 8.19	-9.9 score on a scale Standard Deviation 7.28
Change From Baseline in DLQI at Weeks 32 and 52 Week 52	-11.3 score on a scale Standard Deviation 7.84	-11.2 score on a scale Standard Deviation 7.08

SECONDARY outcome

Timeframe: Baseline, week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and each time point.

The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'. A negative change from baseline indicates improvement in itch severity.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=151 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Itch NRS Score at Weeks 32 and 52 Week 32	-3.2 score on a scale Standard Deviation 3.50	-2.8 score on a scale Standard Deviation 3.22
Change From Baseline in Itch NRS Score at Weeks 32 and 52 Week 52	-3.9 score on a scale Standard Deviation 3.61	-3.3 score on a scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: Baseline, week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and each time point

Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement in skin discomfort/pain.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=151 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52 Week 32	-28.4 score on a scale Standard Deviation 38.40	-22.6 score on a scale Standard Deviation 33.71
Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52 Week 52	-35.0 score on a scale Standard Deviation 36.76	-31.0 score on a scale Standard Deviation 34.77

SECONDARY outcome

Timeframe: Baseline, week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and each time point

Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on 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 n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=152 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52 Week 32	-49.5 percent change Standard Deviation 47.35	-40.2 percent change Standard Deviation 51.79
Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52 Week 52	-49.9 percent change Standard Deviation 53.25	-32.0 percent change Standard Deviation 93.09

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.

The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=152 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52 Week 52	65.2 percentage of participants Interval 52.8 to 76.3	63.8 percentage of participants Interval 55.6 to 71.4
Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52 Week 32	66.7 percentage of participants Interval 54.3 to 77.6	67.8 percentage of participants Interval 59.7 to 75.1

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.

The PASI score 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. 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). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=152 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percentage of Participants Who Achieved a PASI Score < 3 at Weeks 32 and 52 Week 32	58.0 percentage of participants Interval 45.5 to 69.8	40.1 percentage of participants Interval 32.3 to 48.4
Percentage of Participants Who Achieved a PASI Score < 3 at Weeks 32 and 52 Week 52	50.7 percentage of participants Interval 38.4 to 63.0	37.5 percentage of participants Interval 29.8 to 45.7

SECONDARY outcome

Timeframe: Baseline and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and week 52

EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=112 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percent Change From Baseline in EQ-5D VAS Score at Week 52	51.4 percent change Standard Deviation 132.13	33.6 percent change Standard Deviation 78.53

SECONDARY outcome

Timeframe: Baseline and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and week 52

EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=112 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Percent Change From Baseline in EQ-5D Index Score at Week 52	214.103 percent change Standard Deviation 1799.6328	11.039 percent change Standard Deviation 224.3001

SECONDARY outcome

Timeframe: Baseline and week 52

Population: Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=64 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed	-4.6 percent impairment Standard Deviation 17.43	-3.2 percent impairment Standard Deviation 17.11

SECONDARY outcome

Timeframe: Baseline and week 52

Population: Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=64 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment	-21.0 percent impairment Standard Deviation 29.82	-24.4 percent impairment Standard Deviation 26.78

SECONDARY outcome

Timeframe: Baseline and week 52

Population: Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=64 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment	-21.7 percent impairment Standard Deviation 30.12	-25.3 percent impairment Standard Deviation 29.91

SECONDARY outcome

Timeframe: Baseline and week 52

Population: Randomized participants who entered the apremilast extension phase with available data at baseline and week 52

The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg n=75 Participants Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment	-32.7 percent impairment Standard Deviation 33.94	-30.5 percent impairment Standard Deviation 27.01

SECONDARY outcome

Timeframe: From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.

Population: All randomized participants who received at least one dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase and received at least one dose of apremilast.

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a 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 of a preexisting condition was considered an AE. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=254 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Number of Participants With TEAEs During Apremilast Treatment Any TEAE	217 Participants	—
Number of Participants With TEAEs During Apremilast Treatment Drug-related TEAE	152 Participants	—
Number of Participants With TEAEs During Apremilast Treatment Severe TEAEs	14 Participants	—
Number of Participants With TEAEs During Apremilast Treatment Serious TEAEs	18 Participants	—
Number of Participants With TEAEs During Apremilast Treatment Serious drug-related TEAE	2 Participants	—
Number of Participants With TEAEs During Apremilast Treatment TEAE leading to drug interruption	19 Participants	—
Number of Participants With TEAEs During Apremilast Treatment TEAE leading to drug withdrawal	31 Participants	—
Number of Participants With TEAEs During Apremilast Treatment TEAE leading to death	0 Participants	—

SECONDARY outcome

Timeframe: From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.

Population: Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, and with at least 1 post-baseline measurement.

Outcome measures

Outcome measures
Measure	Placebo n=235 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Alanine Aminotransferase > 3 × ULN	2 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Albumin < 25 g/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Alkaline Phosphatase > 400 U/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Aspartate Aminotransferase > 3 × ULN	1 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Bilirubin > 1.8 × ULN	1 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Blood Urea Nitrogen > 15 mmol/L	2 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Calcium < 1.8 mmol/L	1 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Calcium > 3.0 mmol/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Cholesterol > 7.8 mmol/L	3 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Creatinine > 1.7 × ULN	1 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Glucose < 2.8 mmol/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Glucose > 13.9 mmol/L	7 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Hemoglobin A1C (Fasting) > 9%	3 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Lactate Dehydrogenase > 3 × ULN	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Potassium < 3.0 mmol/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Potassium > 5.5 mmol/L	2 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Sodium < 130 mmol/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Sodium > 150 mmol/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Triglycerides > 3.4 mmol/L	22 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Hemoglobin: Female < 85 g/L, Male < 105 g/L	1 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Hemoglobin: Female > 170 g/L, Male > 185 g/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Leukocytes < 1.5 × 10^9/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Lymphocytes < 0.8 × 10^9/L	3 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Neutrophils, Segmented < 1.0 × 10^9/L	0 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Platelets < 75 × 10^9/L	2 Participants	—
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment Platelets > 600 × 10^9/L	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52

Population: Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase, with a baseline value and at least 1 post-baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Blood Pressure at End of Apremilast Extension Period Systolic	0.1 mmHg Standard Deviation 13.68	—
Change From Baseline in Blood Pressure at End of Apremilast Extension Period Diastolic	0.1 mmHg Standard Deviation 8.98	—

SECONDARY outcome

Timeframe: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52

Population: Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Pulse Rate at End of Apremilast Extension Period	1.0 beats/minute Standard Deviation 10.29	—

SECONDARY outcome

Timeframe: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52

Population: Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Body Weight at End of Apremilast Extension Period	-1.20 kg Standard Deviation 3.802	—

SECONDARY outcome

Timeframe: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52

Population: Baseline and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Participants received placebo tablets orally twice a day for 16 weeks.	Apremilast 30 mg Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
Change From Baseline in Waist Circumference at End of Apremilast Extension Period	-0.8 cm Standard Deviation 4.97	—

Adverse Events

Placebo-controlled Period: Placebo

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo-controlled Period: Apremilast 30 mg

Serious events: 8 serious events

Other events: 113 other events

Deaths: 0 deaths

Apremilast Extension Period: Apremilast 30 mg

Serious events: 12 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo-controlled Period: Placebo n=92 participants at risk Participants received placebo tablets orally twice a day for 16 weeks.	Placebo-controlled Period: Apremilast 30 mg n=185 participants at risk Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.	Apremilast Extension Period: Apremilast 30 mg n=221 participants at risk Participants received apremilast 30 mg tablets orally twice a day from week 16 to week 52 (36 weeks).
Gastrointestinal disorders Abdominal pain upper	4.3% 4/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.5% 12/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.4% 3/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	6.5% 6/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.0% 61/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	10.0% 22/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	1.1% 1/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.4% 10/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.8% 4/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	5.4% 5/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 37/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.5% 10/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	12.0% 11/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.7% 18/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	11.3% 25/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	5.4% 5/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 37/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.6% 19/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	10.9% 10/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.7% 5/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.0% 20/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	4.3% 4/92 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.2% 6/185 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.4% 12/221 • Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks. All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER