This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).
Male or female participants ages 18 years of age and older for whom the treating physician had recently prescribed adalimumab were included in this study. Adalimumab was prescribed in accordance with the terms of the local marketing authorization with regards to dose, population, and indication. There were 5 planned visits during the study: baseline (Visit 1), 1 month (Visit 2), 3 months (Visit 3), 6 months (Visit 4), and 9 months (Visit 5).
Study Type
OBSERVATIONAL
Enrollment
246
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (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, Months 1, 3, 6, and 9
Mean Dermatology Life Quality Index (DLQI) Scores
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 respond to 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 that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Time frame: Baseline, Months 1, 3, 6, and 9
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
The percentage of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (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, Months 1, 3, 6, and 9
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
The percentage of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (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, Months 1, 3, 6, and 9
Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
The percentage of participants with a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (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, Months 1, 3, 6, and 9
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months.
Time frame: Baseline, Months 1, 3, 6, and 9
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months.
Time frame: Baseline, Months 1, 3, 6, and 9
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 PCS was defined as an increase in PCS of at least 3 points from the baseline score.
Time frame: Baseline, Months 1, 3, 6, and 9
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 MCS was defined as an increase in MCS of at least 5 points from the baseline score.
Time frame: Baseline, Months 1, 3, 6, and 9
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