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 throughout 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 scores (mTSS) were available for 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 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 favourable risk–benefit profile in patients with PsA.
Trial registration number: NCT00195689.
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Competing interests: PJM has received research grants and speaker’s bureau honorarium from Abbott Laboratories and has served as a consultant for Abbott Laboratories. DDG has received consulting fees and honoraria from Abbott, Amgen, Centocor, Schering and Wyeth and received unrestricted research and education funds from Abbott, Amgen-Wyeth and Schering. PO has received consulting fees or honoraria from Abbott and Amgen. CTR has received consulting fees and honoraria from Abbott, Centocor, Wyeth and Biogen. FVdB has received speaker’s bureau honorarium and has served as a consultant for Abbott Laboratories. JTS has received consulting fees or honoraria from Abbott and Amgen. GTDT reports no competing interests. JM, RJP and RLW are employees of Abbott Laboratories and own shares of Abbott stock.
Funding: The research reported here and the preparation of this manuscript were funded by Abbott Laboratories.
Contributors: The ADEPT Study Group included experts from academic institutions in Europe and the United States and members of Abbott Laboratories who designed the original clinical trial. Clinical data were collected and analysed by Abbott Laboratories. All authors contributed to manuscript development and reviewed and approved the content of the submitted manuscript.