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Adalimumab improves joint- and skin-related functional impairment in patients with psoriatic arthritis: Patient- reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT)
  1. Dafna D Gladman (dafna.gladman{at}utoronto.ca)
  1. Centre for Prognosis Studies, Toronto Western Hospital, Canada
    1. Philip J Mease
    1. University of Washington School of Medicine, United States
      1. Mary A Cifaldi
      1. Global Health Economics & Outcomes Research, Abbott Laboratories, United States
        1. Renee J Perdok
        1. Clinical Statistics, Abbott Laboratories, United States
          1. Eric Sasso
          1. Abbott Immunology, Abbott Laboratories, United States
            1. John Medich
            1. Rheumatology, Immunoscience, Abbott Laboratories, United States

              Abstract

              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.

              • adalimumab
              • patient-reported outcomes
              • psoriatic arthritis
              • quality of life
              • randomised controlled trial

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