ADALIMUMAB TREATMENT EFFECTS ON QUALITY OF LIFE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM ADEPT

Background: Psoriatic arthritis (PsA) results in functional impairment in a large proportion of patients, including a progressive increase both in the number of affected joints and in the severity of joint damage, which can lead to discomfort, disfigurement, and disability. Effective treatment may significantly improve the quality of life in these patients.Objectives: To evaluate the ability of adalimumab compared with placebo to improve quality of life in patients with moderate to severe PsA.Methods: Adult patients with moderate to severely active PsA (≥3 swollen and ≥3 tender joints) who had an inadequate response to NSAIDs were included in the study. Patients were stratified for MTX use (yes/no) and extent of psoriasis (<3% or ≥3% Body Surface Area [BSA]), and randomized to receive either adalimumab 40 mg or placebo subcutaneously every other week for 24 weeks. Quality of life assessment instruments included the disability index of the Health Assessment Questionnaire (HAQ), the Short Form-36 Health Status Survey (SF-36) and the Fatigue scale of the Functional Assessment of Chronic Illness Therapy (FACIT-F). In patients with psoriasis involving ≥3% of BSA, Dermatology Life Quality Index (DLQI) was also assessed. Statistical comparisons were made for adalimumab treatment vs. placebo treatment.Results: Three hundred thirteen patients were treated (N=151 adalimumab, N=162 placebo). Baseline characteristics were consistent with patients with moderate to severely active PsA. As previously reported, the ACR20/50/70 responses for adalimumab-treated patients at Week 24 were 57/39/23, and in 69 patients with ≥3% BSA psoriasis, the PASI 50/75/90 responses were 75/59/42. Disability improvement, as measured by the mean change in HAQ score, was both clinically (>0.3 units change) and statistically (p<0.001) significant: adalimumab patients, -0.4 units vs. placebo patients, -0.1 units. Quality of life, as measured by SF-36, was markedly reduced at baseline, compared to US population norms, and was well-matched between treatment groups. After 24 weeks of treatment, patients receiving adalimumab exhibited clinically (mean change from baseline ≥10 units) significant changes in 7 of the 8 SF-36 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, and role-emotional) while placebo patients did not demonstrate clinically significant changes in any domains. Changes were statistically significant vs. placebo (p<0.01) for 6 of these 7 domains with clinical significance (all except role-emotional). Mean improvement in FACIT-F scores at 24 weeks for patients receiving adalimumab was 7.1 compared with 0.1 for those receiving placebo (p<0.001). In patients with ≥3% BSA psoriasis, (adalimumab n=66, placebo n=66), mean changes from baseline in DLQI scores were -6.1 and -0.7, respectively (p<0.001), at Week 24. Adalimumab was generally well-tolerated during the study.Conclusion: In this study, adalimumab treatment provides clinically meaningful and statistically significant improvement in several quality of life instruments in patients with moderate to severely active PsA compared with placebo.Citation: Ann Rheum Dis, volume 64, supplement III, year 2005, page 317Session: Spondylarthropathies including psoriatic arthritis