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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
  1. D D Gladman1,
  2. P J Mease2,
  3. M A Cifaldi3,
  4. R J Perdok4,
  5. E Sasso5,
  6. J Medich6
  1. 1University 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. 2Seattle Rheumatology Associates and Swedish Rheumatology Research Division, University of Washington School of Medicine, Seattle, Washington, USA
  3. 3Global Health Economics & Outcomes Research, Global Pharmaceutical Research & Development, Abbott Laboratories, Abbott Park, Illinois, USA
  4. 4Clinical Statistics, Abbott Laboratories, Abbott Park, Illinois, USA
  5. 5Abbott Immunology, Abbott Laboratories, Abbott Park, Illinois, USA
  6. 6Rheumatology, Immunoscience, Abbott Laboratories, Parsippany, New Jersey, USA
  1. 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

Abstract

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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Footnotes

  • Published Online First 20 December 2006

  • Funding: PJM, has received research grants and speaker’s bureau honorarium from Abbott Laboratories and has served as a consultant for Abbott Laboratories. MAC, RJP and ES, are employees of Abbott Laboratories. JM is an employee of Abbott Laboratories and owns shares of Abbott stock.

  • Competing interests: None.

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