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Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

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ClinicalTrials.gov Identifier: NCT01202565
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Time Perspective: Prospective
Condition Moderate to Severe Plaque Psoriasis
Enrollment 506
Recruitment Details The study was conducted in Slovenia, Hungary, Slovakia, Romania, Israel, Czech Republic, Ukraine and Estonia.
Pre-assignment Details 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.
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Period Title: Overall Study
Started 506
Full Analysis Set 501 [1]
Completed 439 [2]
Not Completed 67
[1]
Participants with a signed informed consent and any available data regarding adalimumab treatment.
[2]
Indicates participants who completed the Month 12 visit
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Baseline Participants 501
Hide Baseline Analysis Population Description
Full analysis set, which included participants with a signed informed consent and with any available data regarding treatment with adalimumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 501 participants
47.0  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants
Female
187
  37.3%
Male
314
  62.7%
Nail Psoriasis Severity Index (NAPSI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 501 participants
13.0  (2.1)
[1]
Measure Description: 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. In this study the 2 most affected nails on either hands or feet were evaluated for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Data are reported for the Nail Psoriasis Set (NPS), which includes participants with a Baseline NAPSI value ≥ 10 (157 participants).
Psoriasis Scalp Severity Index (PSSI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 501 participants
26.8  (14.1)
[1]
Measure Description: PSSI consists of 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 total 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. Data are reported for the Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI value ≥ 10 (404 participants).
Psoriasis Area and Severity Index (PASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 501 participants
22.0  (9.7)
[1]
Measure Description: 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. PASI data were missing for 2 participants at Baseline.
Dermatology Life Quality Index (DLQI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 501 participants
20.0  (6.5)
[1]
Measure Description: 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 (best) to 30 (worst). Baseline DLQI data were available for 459 participants.
1.Primary Outcome
Title Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
Hide Description

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.

Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 156
Mean (Standard Deviation)
Unit of Measure: percent change
-74.6  (26.9)
2.Primary Outcome
Title Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12
Hide Description

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.

Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 402
Mean (Standard Deviation)
Unit of Measure: percent change
-89.7  (30.0)
3.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Hide Description

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.

Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=154) -4.6  (3.0)
Month 6 (N=144) -7.6  (3.2)
Month 9 (N=136) -9.1  (3.5)
Month 12 (N=125) -10.5  (3.1)
Month 12-LOCF (N=156) -9.6  (3.7)
4.Secondary Outcome
Title Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Hide Description

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).

Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=154) 33.1
Month 6 (N=144) 68.1
Month 9 (N=136) 85.3
Month 12 (N=125) 90.4
Month 12-LOCF (N=156) 84.0
5.Secondary Outcome
Title Percentage of Participants Achieving Complete Clearing of Nails
Hide Description

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).

Time Frame Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=154) 1.9
Month 6 (N=144) 11.8
Month 9 (N=136) 22.1
Month 12 (N=125) 40.0
Month 12-LOCF (N=156) 33.3
6.Secondary Outcome
Title Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Hide Description 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.
Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 404
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=400) -17.2  (11.6)
Month 6 (N=377) -22.2  (12.7)
Month 9 (N=365) -24.2  (14.0)
Month 12 (N=346) -25.8  (14.5)
Month 12-LOCF (N=402) -24.3  (15.1)
7.Secondary Outcome
Title Percentage of Participants Achieving Good Clinical Response on Scalp
Hide Description

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.

Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 404
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=400) 67.0
Month 6 (N=377) 92.8
Month 9 (N=365) 97.5
Month 12 (N=346) 98.3
Month 12-LOCF (N=402) 93.8
8.Secondary Outcome
Title Percentage of Participants Achieving Complete Clearing of Scalp
Hide Description 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.
Time Frame Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 404
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=400) 27.0
Month 6 (N=377) 39.5
Month 9 (N=365) 47.9
Month 12 (N=346) 71.7
Month 12-LOCF (N=402) 66.7
9.Secondary Outcome
Title Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 495
Mean (Standard Deviation)
Unit of Measure: percent change
-83.3  (36.0)
10.Secondary Outcome
Title Change From Baseline in PASI Score
Hide Description 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.
Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 499
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=490) -14.5  (10.1)
Month 6 (N=468) -17.9  (10.2)
Month 9 (N=449) -19.6  (10.1)
Month 12 (N=429) -20.6  (9.9)
Month 12-LOCF (N=495) -19.1  (11.0)
11.Secondary Outcome
Title Percentage of Participants Achieving a PASI 90 Response
Hide Description

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.

Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 499
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=490) 25.1
Month 6 (N=468) 38.0
Month 9 (N=449) 51.4
Month 12 (N=429) 72.0
Month 12-LOCF (N=495) 65.3
12.Secondary Outcome
Title Percentage of Participants Achieving a PASI 75 Response
Hide Description

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.

Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 499
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=490) 43.5
Month 6 (N=468) 66.7
Month 9 (N=449) 84.6
Month 12 (N=429) 91.8
Month 12-LOCF (N=495) 84.0
13.Secondary Outcome
Title Percentage of Participants Achieving a PASI 50 Response
Hide Description

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.

Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 499
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (N=490) 69.2
Month 6 (N= 468) 92.5
Month 9 (N=449) 95.5
Month 12 (N= 429) 97.2
Month 12-LOCF (N=495) 91.1
14.Secondary Outcome
Title Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 452
Mean (Standard Deviation)
Unit of Measure: percent change
-83.6  (41.8)
15.Secondary Outcome
Title Change From Baseline in DLQI Score
Hide Description 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.
Time Frame Baseline and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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."
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 459
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=448) -12.6  (7.1)
Month 6 (N=426) -16.1  (7.2)
Month 9 (N=415) -17.9  (7.0)
Month 12 (N=396) -18.9  (6.9)
Month 12-LOCF (N=453) -17.4  (8.4)
16.Secondary Outcome
Title Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: correlation coefficient
0.61
17.Secondary Outcome
Title Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: correlation coefficient
0.65
18.Secondary Outcome
Title Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis
Hide Description 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.
Time Frame Baseline and Month 12
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Hide Analysis Population Description
Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 139
Measure Type: Number
Unit of Measure: correlation coefficient
0.60
19.Secondary Outcome
Title Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 376
Measure Type: Number
Unit of Measure: correlation coefficient
0.59
20.Secondary Outcome
Title Associations Between General Improvement in Psoriasis With Improvement in Quality of Life
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Overall Number of Participants Analyzed 450
Measure Type: Number
Unit of Measure: correlation coefficient
0.78
Time Frame 12 months
Adverse Event Reporting Description The analysis of adverse events was performed for the full analysis set
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   5/501 (1.00%) 
General disorders   
Death  1  1/501 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung cancer metastatic  1  1/501 (0.20%) 
Nervous system disorders   
Polyneuropathy alcoholic  1  1/501 (0.20%) 
Skin and subcutaneous tissue disorders   
Psoriasis  1  3/501 (0.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Adalimumab
Affected / at Risk (%)
Total   19/501 (3.79%) 
Skin and subcutaneous tissue disorders   
Psoriasis  1  19/501 (3.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
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Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01202565     History of Changes
Other Study ID Numbers: P12-165
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: July 15, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014