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
2006
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.
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