EXTENDED REPORT

Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial

D D Gladman¹, P J Mease², M A Cifaldi³, R J Perdok⁴, E Sasso⁵, J Medich⁶

¹ University of Toronto Rheumatic Disease Unit, and The Psoriatic Arthritis Program, Centre for Prognostic Studies in the Rheumatic Diseases, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada
² Seattle Rheumatology Associates and Swedish Rheumatology Research Division, University of Washington School of Medicine, Seattle, Washington, USA
³ Global Health Economics & Outcomes Research, Global Pharmaceutical Research & Development, Abbott Laboratories, Abbott Park, Illinois, USA
⁴ Clinical Statistics, Abbott Laboratories, Abbott Park, Illinois, USA
⁵ Abbott Immunology, Abbott Laboratories, Abbott Park, Illinois, USA
⁶ Rheumatology, Immunoscience, Abbott Laboratories, Parsippany, New Jersey, USA

Correspondence to:
Dr D D Gladman
Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases, 1E-410B, 399 Bathurst Street, Toronto, Ontario, Canada M5T 2S8; dafna.gladman{at}utoronto.ca

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 (p0.001). 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.

Abbreviations: 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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