Objective: To evaluate the long-term effectiveness and tolerability of adalimumab in the treatment of psoriatic arthritis (PsA).
Methods: Patients with PsA who completed a 24-week, double-blind study of adalimumab versus placebo were eligible to enroll in an open-label extension study and receive adalimumab 40 mg subcutaneously every other week for up to an additional 120 weeks. At the time of this analysis, available efficacy evaluations through 2 years of treatment (n=245) included American College of Rheumatology (ACR) 20%, 50%, and 70% improvement scores, measures of joint disease and skin disease, disability, and quality of life; modified total Sharp score (mTSS) were available through 2.75 years of treatment for patients who received adalimumab in the 24-week study.
Results: After 24 weeks of double-blind treatment, the mean change in mTSS was –0.2 for the adalimumab group (N = 144) and 1.0 for the placebo group (N = 152) (p<0.001), and outcomes for all individual ACR component variables were significantly improved in adalimumab- compared with placebo-treated patients. Compared with 24-week responses, inhibition of radiographic progression and improvements in joint disease were maintained in most patients during long-term, open-label adalimumab treatment. Also, improvements in skin disease were maintained, with >20% of patients achieving the strict criterion of Psoriasis Area and Severity Index (PASI) 100. The nature and frequency of adverse events during long-term adalimumab treatment were consistent with the safety profile during short-term treatment.
Conclusions: The clinical and radiographic efficacy of adalimumab demonstrated during short-term treatment was sustained during long-term treatment. Adalimumab has a favorable risk–benefit profile in patients with PsA.