Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment

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.

Time frame: Week 0 and Week 16

Population: ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.

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).

Time frame: Week 12

Population: 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).

Time frame: Week 2

Population: 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).

Time frame: Week 4

Population: 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).

Time frame: Week 8

Population: 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).

Time frame: Week 16

Population: ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.

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.

Time frame: Week 0 and Week 16

Population: 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.

Time frame: Week 0 and Week 16

Population: 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.

Time frame: Week 0 and Week 16

Population: ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.

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%.

Time frame: Week 0 and Week 12

Population: 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%.

Time frame: Week 0 and Week 16

Population: 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%.

Time frame: Week 0 and Week 4

Population: 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%.

Time frame: Week 0 and Week 8

Population: 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.

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%.

Time frame: Week 0 and Week 16

Population: 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 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%.

Time frame: Week 0 and Week 8

Population: 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.

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%.

Time frame: Week 0 and Week 2

Population: 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.

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.

Time frame: Week 0 and Week 16

Population: 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.

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.

Time frame: Week 0 and Week 16

Population: 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.