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.
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< or =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.
Gladman
D D
DD
Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases, 1E-410B, 399 Bathurst Street, Toronto, Ontario, Canada M5T 2S8. dafna.gladman@utoronto.ca
Mease
P J
PJ
Cifaldi
M A
MA
Perdok
R J
RJ
Sasso
E
E
Medich
J
J
D000068879:Adalimumab; D000328:Adult; D000704:Analysis of Variance; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy* / Q000473:pathology; D004185:Disability Evaluation; D004311:Double-Blind Method; D005060:Europe; D005221:Fatigue / Q000188:drug therapy / Q000473:pathology; D005260:Female; D006801:Humans; D007596:Joints / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000473:pathology; D011788:Quality of Life; D018434:Sickness Impact Profile; D012867:Skin / Q000473:pathology*; D016896:Treatment Outcome; D014481:United States
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab