Objective: To evaluate the effects of adalimumab on patient-reported outcomes of joint- and skin-related functional impairment, health-related quality of life (HRQOL), 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 scale (FACIT-Fatigue), 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. Statistically significant changes from baseline in HAQ DI were reported for adalimumab vs. placebo (-0.4 vs. & -0.1, p<0.001) at both Weeks 12 and 24. At Week 24, statistically 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 vs. placebo (p<0.01). These reported changes in HAQ DI and SF-36 were also clinically important. Significantly more adalimumab patients had complete resolution of functional loss (HAQ DI=0) and dermatologic-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 vs. placebo at Weeks 12 and 24 (p<0.001 for all).
Conclusions: Adalimumab improved physical- and dermatologic-related functional limitations, HRQOL, fatigue, and pain in patients with PsA treated for 24 weeks.
- patient-reported outcomes
- psoriatic arthritis
- quality of life
- randomised controlled trial