Trial Outcomes & Findings for Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice (NCT NCT01202565)
NCT ID: NCT01202565
Last Updated: 2014-08-07
Results Overview
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
COMPLETED
506 participants
Baseline and Month 12
2014-08-07
Participant Flow
The study was conducted in Slovenia, Hungary, Slovakia, Romania, Israel, Czech Republic, Ukraine and Estonia.
Reasons for study discontinuation were not systematically collected. Five participants were lost to follow-up after the Baseline visit and had no entries regarding treatment with adalimumab and were excluded from the full analysis set (FAS) which finally comprises 501 participants.
Participant milestones
| Measure |
Adalimumab
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Overall Study
STARTED
|
506
|
|
Overall Study
Full Analysis Set
|
501
|
|
Overall Study
COMPLETED
|
439
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Baseline characteristics by cohort
| Measure |
Adalimumab
n=501 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
314 Participants
n=5 Participants
|
|
Nail Psoriasis Severity Index (NAPSI) Score
|
13.0 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Psoriasis Scalp Severity Index (PSSI) Score
|
26.8 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) Score
|
22.0 units on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Dermatology Life Quality Index (DLQI) Score
|
20.0 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Nail Psoriasis set, which includes participants with a Baseline NAPSI score ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=156 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
|
-74.6 percent change
Standard Deviation 26.9
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=402 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12
|
-89.7 percent change
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=157 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Month 3 (N=154)
|
-4.6 units on a scale
Standard Deviation 3.0
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Month 6 (N=144)
|
-7.6 units on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Month 9 (N=136)
|
-9.1 units on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Month 12 (N=125)
|
-10.5 units on a scale
Standard Deviation 3.1
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Month 12-LOCF (N=156)
|
-9.6 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score. The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Outcome measures
| Measure |
Adalimumab
n=157 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Month 3 (N=154)
|
33.1 percentage of participants
|
|
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Month 6 (N=144)
|
68.1 percentage of participants
|
|
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Month 9 (N=136)
|
85.3 percentage of participants
|
|
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Month 12 (N=125)
|
90.4 percentage of participants
|
|
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Month 12-LOCF (N=156)
|
84.0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, and 12Population: Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
Complete clearing of nails is defined as a total NAPSI score of zero. The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Outcome measures
| Measure |
Adalimumab
n=157 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving Complete Clearing of Nails
Month 3 (N=154)
|
1.9 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Nails
Month 6 (N=144)
|
11.8 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Nails
Month 9 (N=136)
|
22.1 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Nails
Month 12 (N=125)
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Nails
Month 12-LOCF (N=156)
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=404 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Month 3 (N=400)
|
-17.2 units on a scale
Standard Deviation 11.6
|
|
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Month 6 (N=377)
|
-22.2 units on a scale
Standard Deviation 12.7
|
|
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Month 9 (N=365)
|
-24.2 units on a scale
Standard Deviation 14.0
|
|
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Month 12 (N=346)
|
-25.8 units on a scale
Standard Deviation 14.5
|
|
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Month 12-LOCF (N=402)
|
-24.3 units on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Outcome measures
| Measure |
Adalimumab
n=404 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving Good Clinical Response on Scalp
Month 3 (N=400)
|
67.0 percentage of participants
|
|
Percentage of Participants Achieving Good Clinical Response on Scalp
Month 6 (N=377)
|
92.8 percentage of participants
|
|
Percentage of Participants Achieving Good Clinical Response on Scalp
Month 9 (N=365)
|
97.5 percentage of participants
|
|
Percentage of Participants Achieving Good Clinical Response on Scalp
Month 12 (N=346)
|
98.3 percentage of participants
|
|
Percentage of Participants Achieving Good Clinical Response on Scalp
Month 12-LOCF (N=402)
|
93.8 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, and 12Population: Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Outcome measures
| Measure |
Adalimumab
n=404 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving Complete Clearing of Scalp
Month 3 (N=400)
|
27.0 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Scalp
Month 6 (N=377)
|
39.5 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Scalp
Month 9 (N=365)
|
47.9 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Scalp
Month 12 (N=346)
|
71.7 percentage of participants
|
|
Percentage of Participants Achieving Complete Clearing of Scalp
Month 12-LOCF (N=402)
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=495 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
|
-83.3 percent change
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=499 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Change From Baseline in PASI Score
Month 3 (N=490)
|
-14.5 units on a scale
Standard Deviation 10.1
|
|
Change From Baseline in PASI Score
Month 6 (N=468)
|
-17.9 units on a scale
Standard Deviation 10.2
|
|
Change From Baseline in PASI Score
Month 9 (N=449)
|
-19.6 units on a scale
Standard Deviation 10.1
|
|
Change From Baseline in PASI Score
Month 12 (N=429)
|
-20.6 units on a scale
Standard Deviation 9.9
|
|
Change From Baseline in PASI Score
Month 12-LOCF (N=495)
|
-19.1 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Adalimumab
n=499 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving a PASI 90 Response
Month 3 (N=490)
|
25.1 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Month 6 (N=468)
|
38.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Month 9 (N=449)
|
51.4 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Month 12 (N=429)
|
72.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Month 12-LOCF (N=495)
|
65.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Adalimumab
n=499 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving a PASI 75 Response
Month 3 (N=490)
|
43.5 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Month 6 (N=468)
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Month 9 (N=449)
|
84.6 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Month 12 (N=429)
|
91.8 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Month 12-LOCF (N=495)
|
84.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Adalimumab
n=499 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percentage of Participants Achieving a PASI 50 Response
Month 3 (N=490)
|
69.2 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Month 6 (N= 468)
|
92.5 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Month 9 (N=449)
|
95.5 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Month 12 (N= 429)
|
97.2 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Month 12-LOCF (N=495)
|
91.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=452 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
|
-83.6 percent change
Standard Deviation 41.8
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, and 12Population: Full Analysis Set with Baseline DLQI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by "N."
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Adalimumab
n=459 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Change From Baseline in DLQI Score
Month 3 (N=448)
|
-12.6 units on a scale
Standard Deviation 7.1
|
|
Change From Baseline in DLQI Score
Month 6 (N=426)
|
-16.1 units on a scale
Standard Deviation 7.2
|
|
Change From Baseline in DLQI Score
Month 9 (N=415)
|
-17.9 units on a scale
Standard Deviation 7.0
|
|
Change From Baseline in DLQI Score
Month 12 (N=396)
|
-18.9 units on a scale
Standard Deviation 6.9
|
|
Change From Baseline in DLQI Score
Month 12-LOCF (N=453)
|
-17.4 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.
Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Outcome measures
| Measure |
Adalimumab
n=155 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis
|
0.61 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.
Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Outcome measures
| Measure |
Adalimumab
n=399 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis
|
0.65 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.
Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Outcome measures
| Measure |
Adalimumab
n=139 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis
|
0.60 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.
Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Outcome measures
| Measure |
Adalimumab
n=376 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis
|
0.59 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.
Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Outcome measures
| Measure |
Adalimumab
n=450 Participants
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Associations Between General Improvement in Psoriasis With Improvement in Quality of Life
|
0.78 correlation coefficient
|
Adverse Events
Adalimumab
Serious adverse events
| Measure |
Adalimumab
n=501 participants at risk
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
General disorders
Death
|
0.20%
1/501 • 12 months
The analysis of adverse events was performed for the full analysis set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.20%
1/501 • 12 months
The analysis of adverse events was performed for the full analysis set
|
|
Nervous system disorders
Polyneuropathy alcoholic
|
0.20%
1/501 • 12 months
The analysis of adverse events was performed for the full analysis set
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.60%
3/501 • 12 months
The analysis of adverse events was performed for the full analysis set
|
Other adverse events
| Measure |
Adalimumab
n=501 participants at risk
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.8%
19/501 • 12 months
The analysis of adverse events was performed for the full analysis set
|
Additional Information
Global Medical Services
AbbVie
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER