Trial Outcomes & Findings for A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis. (NCT NCT02425826)
NCT ID: NCT02425826
Last Updated: 2023-06-05
Results Overview
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is 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. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA\*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes.
COMPLETED
PHASE4
221 participants
Baseline to Week 16 (end of phase)
2023-06-05
Participant Flow
Participants enrolled into this study were those with moderate plaque psoriasis without prior treatment with systemic agents or biologics and were enrolled across 25 study centers in the United States.
Participants were randomized in a 2 to 1 ratio to receive apremilast or placebo.
Participant milestones
| Measure |
Apremilast
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
Placebo
Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16)
|
Placebo-Apremilast
Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
|
|---|---|---|---|
|
Placebo-controlled Phase (Week 0 - 16)
STARTED
|
148
|
73
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
Intent to Treat
|
147
|
73
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
COMPLETED
|
121
|
64
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
NOT COMPLETED
|
27
|
9
|
0
|
|
Apremilast Extension Phase (Weeks 16-52)
STARTED
|
121
|
0
|
64
|
|
Apremilast Extension Phase (Weeks 16-52)
Received Treatment
|
121
|
0
|
64
|
|
Apremilast Extension Phase (Weeks 16-52)
COMPLETED
|
86
|
0
|
50
|
|
Apremilast Extension Phase (Weeks 16-52)
NOT COMPLETED
|
35
|
0
|
14
|
|
Post-Treatment Observational Follow-Up
STARTED
|
81
|
0
|
49
|
|
Post-Treatment Observational Follow-Up
COMPLETED
|
80
|
0
|
49
|
|
Post-Treatment Observational Follow-Up
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Apremilast
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
Placebo
Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16)
|
Placebo-Apremilast
Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
|
|---|---|---|---|
|
Placebo-controlled Phase (Week 0 - 16)
Adverse Event
|
5
|
2
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
Lack of Efficacy
|
0
|
1
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
Withdrawal by Subject
|
9
|
1
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
Lost to Follow-up
|
10
|
4
|
0
|
|
Placebo-controlled Phase (Week 0 - 16)
Other
|
3
|
1
|
0
|
|
Apremilast Extension Phase (Weeks 16-52)
Adverse Event
|
7
|
0
|
2
|
|
Apremilast Extension Phase (Weeks 16-52)
Lost to Follow-up
|
8
|
0
|
6
|
|
Apremilast Extension Phase (Weeks 16-52)
Withdrawal by Subject
|
12
|
0
|
4
|
|
Apremilast Extension Phase (Weeks 16-52)
Lack of Efficacy
|
8
|
0
|
1
|
|
Apremilast Extension Phase (Weeks 16-52)
miscellaneous
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.
Baseline characteristics by cohort
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=148 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
180 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 13.74 • n=93 Participants
|
48.6 years
STANDARD_DEVIATION 15.41 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 14.89 • n=27 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Body Surface Area (BSA)
|
7.1 percent affected
STANDARD_DEVIATION 1.75 • n=93 Participants
|
7.2 percent affected
STANDARD_DEVIATION 1.61 • n=4 Participants
|
7.2 percent affected
STANDARD_DEVIATION 1.66 • n=27 Participants
|
|
Static Physician's Global Assessment (sPGA) Score
1 = Almost Clear
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Static Physician's Global Assessment (sPGA) Score
2 = Mild
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Static Physician's Global Assessment (sPGA) Score
3 = Moderate
|
70 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
214 Participants
n=27 Participants
|
|
Static Physician's Global Assessment (sPGA) Score
4 =Severe
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Static Physician's Global Assessment (sPGA) Score
5 = Very Severe
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Static Physician's Global Assessment (sPGA) Score
Missing
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Product of BSA and sPGA
|
21.6 psoriasis severity index
STANDARD_DEVIATION 5.87 • n=93 Participants
|
21.8 psoriasis severity index
STANDARD_DEVIATION 5.17 • n=4 Participants
|
21.7 psoriasis severity index
STANDARD_DEVIATION 5.40 • n=27 Participants
|
|
Duration of Psoriasis
|
12.85 years
STANDARD_DEVIATION 12.350 • n=93 Participants
|
17.02 years
STANDARD_DEVIATION 14.138 • n=4 Participants
|
15.64 years
STANDARD_DEVIATION 13.684 • n=27 Participants
|
|
Ethnicity
Hispanic or Latino
|
4 participants
n=93 Participants
|
13 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
69 participants
n=93 Participants
|
134 participants
n=4 Participants
|
203 participants
n=27 Participants
|
|
Ethnicity
Unknown
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The Intent-to-Treat (ITT) population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value were included. A missing value at Week 16 was imputed by last observation carried forward. (LOCF).
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is 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. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA\*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=147 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16
|
-10.17 percentage change
Standard Deviation 64.043
|
-48.07 percentage change
Standard Deviation 43.699
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by 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=71 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=144 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
-2.4 units on a scale
Standard Deviation 6.62
|
-4.8 units on a scale
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with and at least one post-baseline value are included. A missing value at Week 16 was imputed by LOCF.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=148 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline
|
9.6 percentage of participants
Interval 4.7 to 18.5
|
30.4 percentage of participants
Interval 23.6 to 38.2
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=148 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline
|
20.5 percentage of participants
Interval 12.9 to 31.2
|
33.8 percentage of participants
Interval 26.7 to 41.7
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1 and 16 (end of phase)Population: ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=148 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)
Week 1
|
-9.6 units on a scale
Standard Deviation 21.50
|
-13.9 units on a scale
Standard Deviation 20.00
|
|
Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)
Week 16
|
-10.2 units on a scale
Standard Deviation 30.73
|
-19.2 units on a scale
Standard Deviation 26.09
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population with scalp psoriasis who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline.
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=112 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.
|
38.2 percentage of participants
Interval 26.5 to 51.4
|
50.0 percentage of participants
Interval 40.9 to 59.1
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed LOCF.
The TSQM version II is an 11-question self-administered instrument to understand a participation's satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=146 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16
TSQM-Effectiveness
|
38.81 units on a scale
Standard Deviation 25.843
|
57.25 units on a scale
Standard Deviation 26.484
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16
TSQM-Side Effects
|
75.00 units on a scale
Standard Deviation 32.428
|
78.50 units on a scale
Standard Deviation 20.858
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16
TSQM-Convenience
|
65.68 units on a scale
Standard Deviation 16.650
|
66.93 units on a scale
Standard Deviation 21.216
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16
TSQM-Global Satisfaction
|
48.74 units on a scale
Standard Deviation 25.673
|
63.24 units on a scale
Standard Deviation 23.624
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Apremilast participants who entered and were treated in the apremilast extension phase.
The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=121 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52
TSQM-Effectiveness
|
57.68 units on a scale
Standard Deviation 26.879
|
54.13 units on a scale
Standard Deviation 26.898
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52
TSQM-Side Effects
|
77.29 units on a scale
Standard Deviation 27.541
|
75.45 units on a scale
Standard Deviation 24.904
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52
TSQM-Convenience
|
72.74 units on a scale
Standard Deviation 17.222
|
71.76 units on a scale
Standard Deviation 19.359
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52
TSQM-Global Satisfaction
|
59.24 units on a scale
Standard Deviation 27.941
|
59.92 units on a scale
Standard Deviation 27.053
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=147 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16
|
-3.87 percentage change
Standard Deviation 79.441
|
-40.72 percentage change
Standard Deviation 49.523
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=148 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.
|
24.7 percentage of participants
Interval 16.2 to 35.6
|
53.4 percentage of participants
Interval 45.4 to 61.2
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (end of phase)Population: The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=148 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16
|
8.2 percentage of participants
Interval 3.8 to 16.8
|
21.6 percentage of participants
Interval 15.8 to 28.9
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Apremilast participants who entered and were treated in the apremilast extension phase.
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is 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. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=121 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52
|
-42.23 percentage change
Standard Deviation 93.211
|
-55.45 percentage change
Standard Deviation 44.619
|
SECONDARY outcome
Timeframe: Week 16 to Week 52Population: Participants who were initially randomized to apremilast and continued through week 52.
The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.
Responder status at Week 16
|
50.0 percentage of participants
Interval 40.9 to 59.1
|
—
|
|
Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.
Responder status maintained at Week 52
|
80.4 percentage of participants
Interval 68.2 to 88.7
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phasePopulation: The safety population includes all participants who were randomized and received at least one dose of study drug.
Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
n=147 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ At Least 1 TEAE
|
35 participants
|
92 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ 1 Drug-related TEAE
|
21 participants
|
71 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ At Least 1 Severe TEAE
|
1 participants
|
3 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ At Least 1 Serious TEAE
|
0 participants
|
3 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ 1 Serious Drug-related TEAE
|
0 participants
|
0 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ 1 TEAE leading to drug withdrawal
|
3 participants
|
5 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
≥ 1 TEAE Leading to drug interruption
|
3 participants
|
9 participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any TEAE leading to death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phasePopulation: The safety population includes all participants who were randomized and received at least one dose of study drug; apremilast participants as treated.
Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Placebo
n=211 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
|
Apremilast
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ At Least 1 TEAE
|
142 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ 1 Drug-related TEAE
|
98 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ At Least 1 Severe TEAE
|
5 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ At Least 1 Serious TEAE
|
10 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ 1 Serious Drug-related TEAE
|
1 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ 1 TEAE leading to drug withdrawal
|
14 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
≥ 1 TEAE Leading to drug interruption
|
27 participants
|
—
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
Any TEAE leading to death
|
0 participants
|
—
|
Adverse Events
Placebo-Controlled Phase: Apremilast (Weeks 0-16)
Placebo-Controlled Phase: Placebo (Weeks 0-16)
Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
Serious adverse events
| Measure |
Placebo-Controlled Phase: Apremilast (Weeks 0-16)
n=147 participants at risk
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
Placebo-Controlled Phase: Placebo (Weeks 0-16)
n=73 participants at risk
Participants initially randomized to identically matching placebo tablets PO BID during the placebo-controlled phase. (Weeks 0-16).
|
Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
n=211 participants at risk
Includes participants initially randomized to apremilast tablets BID in the placebo controlled phase and continued on apremilast (Apremilast/Apremilast), as well as those who were initially randomized to placebo and switched at week 16 (Placebo/Apremilast) to Apremilast 30 mg tablets BID during weeks 16-52
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
1/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Infections and infestations
Pyelonephritis
|
0.68%
1/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.68%
1/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
1/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.00%
0/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
0.47%
1/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
Other adverse events
| Measure |
Placebo-Controlled Phase: Apremilast (Weeks 0-16)
n=147 participants at risk
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
|
Placebo-Controlled Phase: Placebo (Weeks 0-16)
n=73 participants at risk
Participants initially randomized to identically matching placebo tablets PO BID during the placebo-controlled phase. (Weeks 0-16).
|
Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
n=211 participants at risk
Includes participants initially randomized to apremilast tablets BID in the placebo controlled phase and continued on apremilast (Apremilast/Apremilast), as well as those who were initially randomized to placebo and switched at week 16 (Placebo/Apremilast) to Apremilast 30 mg tablets BID during weeks 16-52
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
29.3%
43/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
16.4%
12/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
28.0%
59/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Gastrointestinal disorders
Nausea
|
17.7%
26/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
9.6%
7/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
19.0%
40/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
9/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
2.7%
2/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
5.7%
12/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
5/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
2.7%
2/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
10.4%
22/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
10/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
4.1%
3/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
7.1%
15/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
6/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
5.5%
4/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
5.2%
11/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
|
Nervous system disorders
Headache
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20.4%
30/147 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
11.0%
8/73 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
15.2%
32/211 • Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
Celgene Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
- Publication restrictions are in place
Restriction type: OTHER