Impact of adalimumab treatment on patient‐reported outcomes: Results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis

Abstract

Objective: The effect of adalimumab on patient‐reported outcomes (PROs) was evaluated in patients with moderate to severe psoriasis during the initial 16‐week, double‐blind period of a 52‐week, Phase III, multicenter trial. Methods: Patients were randomized to placebo or adalimumab 80 mg at Week 0 and 40 mg every other week from Week 1 to Week 15. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), the Short Form 36 Health Survey (SF‐36), the Work Productivity and Activity Impairment Questionnaire‐Specific Health Problem (WPAI‐SHP), and several patient‐rated symptom scales. Results: The adalimumab‐treated group reported significantly greater improvements in DLQI total score (p<0.001), SF‐36 Physical Component Summary score (p<0.001), and Mental Component Summary score (p<0.001) compared with the placebo‐treated group over 16 weeks. Significant differences, favoring adalimumab, were also seen for the DLQI subscale scores (p < 0.001); SF‐36 scale scores (p<0.001); WPAI‐SHP work impairment (p<0.001), activity limitation (p<0.001), and overall work impairment scores (p<0.001); patient's global assessment of disease severity (p<0.001), psoriasis pain (p<0.001), and psoriasis‐related pruritus (p = 0.002). Conclusion: Adalimumab was efficacious in improving dermatology‐specific and general health‐related quality of life, work and activity limitations, and psoriasis‐related symptoms in patients with moderate to severe psoriasis over a 16‐week period.