Trial Outcomes & Findings for Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (NCT NCT00574249)
NCT ID: NCT00574249
Last Updated: 2011-04-13
Results Overview
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.
COMPLETED
PHASE3
730 participants
Week 0 and Week 16
2011-04-13
Participant Flow
Participant milestones
| Measure |
Adalimumab + Placebo
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
|
Adalimumab + Calcipotriol/Betamethasone
adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
|
|---|---|---|
|
Overall Study
STARTED
|
364
|
366
|
|
Overall Study
COMPLETED
|
338
|
338
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
Reasons for withdrawal
| Measure |
Adalimumab + Placebo
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
|
Adalimumab + Calcipotriol/Betamethasone
adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
18
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
History of carcinoma
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Excluded by company
|
0
|
1
|
|
Overall Study
PPD test taken twice
|
0
|
1
|
Baseline Characteristics
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Baseline characteristics by cohort
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
Total
n=730 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
343 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
693 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age Continuous
|
44.8 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 11.95 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
40 participants
n=5 Participants
|
36 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
France
|
58 participants
n=5 Participants
|
61 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
79 participants
n=5 Participants
|
83 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
33 participants
n=5 Participants
|
26 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 16Population: ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
|
70.9 percentage of participants
|
64.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Population: ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
|
82.7 percentage of participants
|
80.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Population: ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
|
50.3 percentage of participants
|
38.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Population: ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
|
24.2 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal.
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
|
7.1 percentage of participants
|
13.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal.
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
|
24.5 percentage of participants
|
33.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal.
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
|
46.2 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal.
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
|
64.8 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Outcome measures
| Measure |
Adalimumab + Placebo
n=364 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
|
64.6 percentage of participants
|
56.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Population: Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change.
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=354 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=363 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
|
-71.46 percent change in score
Standard Deviation 49.171
|
-67.20 percent change in score
Standard Deviation 45.463
|
SECONDARY outcome
Timeframe: Week 0 and Week 2Population: Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=346 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=361 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
|
-32.14 percent change in score
Standard Deviation 44.118
|
-47.49 percent change in score
Standard Deviation 41.093
|
SECONDARY outcome
Timeframe: Week 0 and Week 4Population: Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=354 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=362 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
|
-46.64 percent change in score
Standard Deviation 68.139
|
-60.93 percent change in score
Standard Deviation 38.122
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=354 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=363 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
|
-63.30 percent change in score
Standard Deviation 45.404
|
-62.30 percent change in score
Standard Deviation 43.087
|
SECONDARY outcome
Timeframe: Week 0 and Week 12Population: Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=354 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=363 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
|
-69.49 percent change in score
Standard Deviation 45.030
|
-66.75 percent change in score
Standard Deviation 49.195
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Population: Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.
Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=333 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=333 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
|
20.53 percent change in score
Standard Deviation 31.603
|
19.71 percent change in score
Standard Deviation 32.136
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.
Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.
Outcome measures
| Measure |
Adalimumab + Placebo
n=327 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=321 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
|
19.35 percent change in score
Standard Deviation 30.264
|
18.22 percent change in score
Standard Deviation 29.967
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 and Week 16Population: Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.
PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement.
Outcome measures
| Measure |
Adalimumab + Placebo
n=321 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=319 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.
|
-100.00 percent change in score
Interval -100.0 to -87.5
|
-100.00 percent change in score
Interval -100.0 to -80.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 and Week 16Population: Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.
NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop \[salmon patch\] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement.
Outcome measures
| Measure |
Adalimumab + Placebo
n=213 Participants
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=212 Participants
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.
|
-40.00 percent change in score
Interval -66.7 to 0.0
|
-37.50 percent change in score
Interval -68.4 to 0.0
|
Adverse Events
Adalimumab + Placebo
Adalimumab + Calcipotriol/Betamethasone
Serious adverse events
| Measure |
Adalimumab + Placebo
n=364 participants at risk
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 participants at risk
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Cardiac disorders
angina pectoris
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Eye disorders
retinal vein thrombosis
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Eye disorders
vitreous haemorrhage
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
General disorders
oedema peripheral
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Hepatobiliary disorders
hepatitis
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Immune system disorders
anaphylatic shock
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Infections and infestations
abortion infected
|
0.88%
1/113 • Overall study
|
0.00%
0/116 • Overall study
|
|
Infections and infestations
bronchopneumonia
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Infections and infestations
erysipelas
|
0.27%
1/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Infections and infestations
herpes zoster
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Infections and infestations
localised infection
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Infections and infestations
osteomyelitis
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Infections and infestations
pneumonia
|
0.00%
0/364 • Overall study
|
0.55%
2/366 • Overall study
|
|
Infections and infestations
staphylococcal infection
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Investigations
arteriogram coronary
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lymphoma
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant melanoma
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
rectal adenoma
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Nervous system disorders
convulsion
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
acute generalised exanthematous pustulosis
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
dermatitis exfoliative
|
0.55%
2/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
onycholysis
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
psoriasis
|
0.27%
1/364 • Overall study
|
0.27%
1/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
skin inflammation
|
0.27%
1/364 • Overall study
|
0.00%
0/366 • Overall study
|
|
Vascular disorders
peripheral vascular disorder
|
0.00%
0/364 • Overall study
|
0.27%
1/366 • Overall study
|
Other adverse events
| Measure |
Adalimumab + Placebo
n=364 participants at risk
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
|
Adalimumab + Calcipotriol/Betamethasone
n=366 participants at risk
adalimumab + calcipotriol/betamethasone ointment
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
7/364 • Overall study
|
3.0%
11/366 • Overall study
|
|
Gastrointestinal disorders
Nausea
|
1.4%
5/364 • Overall study
|
3.3%
12/366 • Overall study
|
|
General disorders
Asthenia
|
0.55%
2/364 • Overall study
|
2.2%
8/366 • Overall study
|
|
General disorders
Fatigue
|
2.5%
9/364 • Overall study
|
2.2%
8/366 • Overall study
|
|
General disorders
Injection site pain
|
2.2%
8/364 • Overall study
|
0.82%
3/366 • Overall study
|
|
Infections and infestations
Influenza
|
2.2%
8/364 • Overall study
|
1.6%
6/366 • Overall study
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
23/364 • Overall study
|
8.7%
32/366 • Overall study
|
|
Infections and infestations
Oral herpes
|
1.6%
6/364 • Overall study
|
2.5%
9/366 • Overall study
|
|
Infections and infestations
Rhinitis
|
2.7%
10/364 • Overall study
|
1.1%
4/366 • Overall study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
7/364 • Overall study
|
3.0%
11/366 • Overall study
|
|
Nervous system disorders
Headache
|
6.0%
22/364 • Overall study
|
5.2%
19/366 • Overall study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
12/364 • Overall study
|
3.0%
11/366 • Overall study
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.2%
8/364 • Overall study
|
2.5%
9/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
21/364 • Overall study
|
3.6%
13/366 • Overall study
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.7%
17/364 • Overall study
|
5.2%
19/366 • Overall study
|
|
Vascular disorders
Hypertension
|
1.1%
4/364 • Overall study
|
2.7%
10/366 • Overall study
|
|
Infections and infestations
Pharyngitis
|
3.3%
12/364 • Overall study
|
1.9%
7/366 • Overall study
|
Additional Information
Medical Information Specialist
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator shall provide Abbott at least (60) days prior to publication or presentation, for Abbott's review and comment, to ascertain whether any patent subject matter or Abbott confidential information are disclosed. During the review, Abbott may request a delay for up to six (6) months from the date of first submission to Abbott in order to protect proprietary information.
- Publication restrictions are in place
Restriction type: OTHER