Objective: To evaluate the effects of adalimumab on patient-reported outcomes of joint-related and skin-related functional impairment, health-related quality of life, fatigue and pain in patients with psoriatic arthritis (PsA).
Methods: Patients with moderately- to severely- active PsA were treated with adalimumab, 40 mg, every other week, or placebo, in this 24-week, randomised, controlled trial. Patient-reported outcomes included the Health Assessment Questionnaire Disability Index (HAQ DI), Short-Form 36 Health Survey (SF-36), the Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-Fatigue) Scale and the Dermatology Life Quality Index (DLQI).
Results: Adalimumab (n = 151) and placebo (n = 162) groups were comparable with respect to baseline demographics and disease severity. Significant changes from baseline in HAQ DI were reported for adalimumab v placebo (−0.4 v −0.1, p<0.001) at both 12 and 24 weeks. At week 24, significant improvements in the SF-36 domains of physical functioning, role-physical, bodily pain, general health, vitality and social functioning, as well as the physical component summary score, were observed for adalimumab versus placebo (p<0.01). These reported changes in HAQ DI and SF-36 were also clinically important. Significantly more patients treated with adalimumab had complete resolution of functional loss (HAQ DI = 0) and dermatological-related functional limitations (DLQI = 0) compared with placebo at weeks 12 and 24 (p⩽0.001). Adalimumab led to significantly greater improvements in FACIT-Fatigue scores, pain scores, and disease activity measures versus placebo at 12 and 24 weeks (p<0.001 for all).
Conclusions: Adalimumab improved physical-related and dermatological-related functional limitations, HRQOL, fatigue and pain in patients with PsA treated for 24 weeks.
- ACR, American College of Rheumatology
- ADEPT, Adalimumab Effectiveness in Psoriatic Arthritis Trial
- BSA, body surface area
- DLQI, Dermatology Life Quality Index
- FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue
- HAQ DI, Health Assessment Questionnaire Disability Index
- MCID, minimum clinically-important difference
- MCS, mental component summary
- MTX, methotrexate
- PASI, Psoriasis Area and Severity Index
- PCS, physical component summary
- PsA, psoriatic arthritis
- QOL, quality of life
- SF-36, Short-Form 36 Health Survey
- TNF, tumour necrosis factor
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