Trial Outcomes & Findings for Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis (NCT NCT01690299)
NCT ID: NCT01690299
Last Updated: 2022-03-15
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). The PASI score was set to missing if any severity score or degree of involvement was missing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2022-03-15
Participant Flow
The study was conducted at 65 study centers in 11 countries.
Participants were randomized 1:1:1 to the three treatment groups. Participants were stratified according to their calculated body mass index (BMI) categories at Screening (BMI \< 30 or BMI ≥ 30).
Participant milestones
| Measure |
Placebo
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Placebo/Apremilast
Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
|
Apremilast/Apremilast
Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
|
Etanercept/Apremilast
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.
|
|---|---|---|---|---|---|---|
|
Placebo-controlled Phase (Weeks 0-16)
STARTED
|
84
|
83
|
83
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Weeks 0-16)
Safety Population
|
84
|
83
|
83
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Weeks 0-16)
COMPLETED
|
75
|
77
|
81
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Weeks 0-16)
NOT COMPLETED
|
9
|
6
|
2
|
0
|
0
|
0
|
|
Apremilast Extension Phase (Weeks16-104)
STARTED
|
0
|
0
|
0
|
73
|
74
|
80
|
|
Apremilast Extension Phase (Weeks16-104)
Safety Population
|
0
|
0
|
0
|
73
|
74
|
79
|
|
Apremilast Extension Phase (Weeks16-104)
COMPLETED
|
0
|
0
|
0
|
47
|
41
|
50
|
|
Apremilast Extension Phase (Weeks16-104)
NOT COMPLETED
|
0
|
0
|
0
|
26
|
33
|
30
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Placebo/Apremilast
Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
|
Apremilast/Apremilast
Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
|
Etanercept/Apremilast
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.
|
|---|---|---|---|---|---|---|
|
Placebo-controlled Phase (Weeks 0-16)
Adverse Event
|
2
|
2
|
1
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Weeks 0-16)
Lack of Efficacy
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Weeks 0-16)
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Weeks 0-16)
Other
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Apremilast Extension Phase (Weeks16-104)
Adverse Event
|
0
|
0
|
0
|
3
|
4
|
3
|
|
Apremilast Extension Phase (Weeks16-104)
Lack of Efficacy
|
0
|
0
|
0
|
9
|
10
|
8
|
|
Apremilast Extension Phase (Weeks16-104)
Non-compliance With Study Drug
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Apremilast Extension Phase (Weeks16-104)
Withdrawal by Subject
|
0
|
0
|
0
|
8
|
5
|
11
|
|
Apremilast Extension Phase (Weeks16-104)
Lost to Follow-up
|
0
|
0
|
0
|
6
|
13
|
6
|
|
Apremilast Extension Phase (Weeks16-104)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 14.91 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 13.59 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 14.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).
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). The PASI score was set to missing if any severity score or degree of involvement was missing.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline
|
11.9 Percentage of participants
|
39.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).
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). The PASI score was set to missing if any severity score or degree of involvement was missing.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16
|
11.9 percentage of participants
|
48.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
|
3.6 percentage of participants
|
21.7 percentage of participants
|
28.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.
BSA 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" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100\*(post-baseline BSA - baseline BSA) / baseline BSA.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
|
-16.3 percent change
Interval -23.71 to -8.81
|
-47.7 percent change
Interval -55.2 to -40.12
|
-56.1 percent change
Interval -63.63 to -48.59
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).
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 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). The PASI score was set to missing if any severity score or degree of involvement was missing.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
|
33.3 percentage of participants
|
62.7 percentage of participants
|
83.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=79 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=80 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
|
-3.9 units on a scale
Interval -5.34 to -2.42
|
-8.4 units on a scale
Interval -9.84 to -6.88
|
-7.8 units on a scale
Interval -9.28 to -6.34
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.
The SF-36 is 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. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=80 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=80 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
|
2.6 units on a scale
Interval 0.72 to 4.43
|
3.5 units on a scale
Interval 1.62 to 5.38
|
4.8 units on a scale
Interval 2.92 to 6.67
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.
The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
|
6.0 percentage of participants
|
24.1 percentage of participants
|
22.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept groupPopulation: Safety population includes all participants who were randomized and received at least one dose of study drug.
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE 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 or may require intervention to prevent one of the outcomes above.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE
|
45 participants
|
59 participants
|
44 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Drug-related TEAE
|
17 participants
|
27 participants
|
21 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Severe TEAE
|
2 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Serious TEAE
|
0 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Serious Drug-related TEAE
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE Leading to Drug Interruption
|
1 participants
|
9 participants
|
3 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE Leading to Drug Withdrawal
|
2 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE Leading to Death
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dosePopulation: All participants who received apremilast at any time during the study.
A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject'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) should be considered an AE. A serious AE (SAE) is any untoward AE 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 or may require intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=79 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any TEAE
|
45 participants
|
71 participants
|
54 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any Drug-related TEAE
|
23 participants
|
36 participants
|
15 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any Severe TEAE
|
4 participants
|
7 participants
|
7 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any Serious TEAE
|
5 participants
|
6 participants
|
4 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any Serious Drug-related TEAE
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any TEAE Leading to Drug Interruption
|
8 participants
|
13 participants
|
7 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any TEAE Leading to Drug Withdrawal
|
3 participants
|
7 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Any TEAE Leading to Death
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 16; Placebo controlled phasePopulation: Safety population includes all participants who were randomized and received at least one dose of study drug.
Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=83 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Psoriasis Flare/Rebound
Any psoriasis rebound captured as a TEAE
|
0 participants
|
0 participants
|
0 participants
|
|
Psoriasis Flare/Rebound
Any psoriasis flare captured as a TEAE
|
3 participants
|
1 participants
|
0 participants
|
|
Psoriasis Flare/Rebound
Those with PASI ≥125% baseline score and D/C APR
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.Population: Safety population includes all participants who were randomized and received at least one dose of study drug.
Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection
n=83 Participants
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablet
n=79 Participants
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
|
|---|---|---|---|
|
Psoriasis Flare/Rebound
Any psoriasis flare captured as a TEAE
|
1 participants
|
4 participants
|
0 participants
|
|
Psoriasis Flare/Rebound
Any psoriasis rebound captured as a TEAE
|
1 participants
|
2 participants
|
7 participants
|
|
Psoriasis Flare/Rebound
Those with PASI ≥125% baseline score and D/C APR
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Placebo (Week 0-16)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Apremilast Plus Placebo Injection (Week 0-16)
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Etanercept Plus Placebo Tablets (Week 0-16)
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Week 0-16)
n=84 participants at risk
Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection (Week 0-16)
n=83 participants at risk
Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablets (Week 0-16)
n=83 participants at risk
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104
n=73 participants at risk
Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
|
APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104
n=83 participants at risk
Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
|
Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104
n=79 participants at risk
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Nervous system disorders
Pneumocephalus
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
Other adverse events
| Measure |
Placebo (Week 0-16)
n=84 participants at risk
Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Apremilast Plus Placebo Injection (Week 0-16)
n=83 participants at risk
Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Etanercept Plus Placebo Tablets (Week 0-16)
n=83 participants at risk
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104
n=73 participants at risk
Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
|
APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104
n=83 participants at risk
Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
|
Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104
n=79 participants at risk
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
10.8%
9/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.8%
5/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
14.5%
12/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.3%
5/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
3/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
10.8%
9/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
17.8%
13/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
14.5%
12/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.6%
6/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
2/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.4%
2/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.8%
5/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
10.8%
9/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
8/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
9.6%
8/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
5.5%
4/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.3%
5/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Nervous system disorders
Headache
|
3.6%
3/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
13.3%
11/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.8%
5/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
14.5%
12/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.8%
3/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Nervous system disorders
Tension Headache
|
4.8%
4/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.6%
3/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.1%
3/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.4%
2/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.7%
2/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.4%
2/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.1%
3/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.5%
2/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Rhinitis
|
1.2%
1/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.5%
2/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.6%
3/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.3%
5/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
2/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.6%
3/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.6%
3/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
5.5%
4/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.8%
3/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
2/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.4%
2/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
5.1%
4/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
2.4%
2/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.1%
3/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
3/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
3.6%
3/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.5%
2/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
4.8%
4/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.6%
3/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.7%
2/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
6.0%
5/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Skin and subcutaneous tissue disorders
Rebound psoriasis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
0.00%
0/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.4%
2/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
8.9%
7/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/84 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
2.4%
2/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.2%
1/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.4%
1/73 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
7.2%
6/83 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
1.3%
1/79 • Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
Celgene Corporation
Phone: 888-260-1599
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 12 months 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