Objective: To determine the long-term effect of adalimumab on patients with ankylosing spondylitis (AS) who participated in the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS), a randomised, double-blind, placebo controlled, 24-week trial.
Methods: Patients received adalimumab 40 mg every other week (eow) or placebo for 24 weeks in ATLAS. At week 24, patients were switched to open-label adalimumab 40 mg eow. Efficacy measures included 20% improvement in the Assessment in SpondyloArthritis International Society (ASAS) criteria (ASAS20), ASAS40 and ASAS partial remission responses and changes in individual components of the ASAS20 response evaluations, for example, Bath AS Functional Index (BASFI) and Bath AS Disease Activity Index (BASDAI). Two-year interim data were analysed based on the total duration of adalimumab exposure, irrespective of the treatment randomisation group.
Results: At 2 years, 255 (82.0%) of the original 311 ATLAS patients continued receiving adalimumab treatment. Improvements in ASAS responses observed in ATLAS were sustained during long-term treatment; 64.5% (200/310) were ASAS20 responders, 50.6% (157/310) were ASAS40 responders and 33.5% (104/310) had maintained ASAS-defined partial remission. Changes in individual ASAS response components were sustained or improved during long-term adalimumab treatment. From ATLAS baseline to 2 years of adalimumab exposure, respectively, BASDAI improved from 6.3 (SD 1.7) to 2.4 (SD 2.3) and BASFI improved from 5.2 (SD 2.4) to 2.9 (SD 2.5). Adalimumab was well tolerated. No cases of tuberculosis, congestive heart failure, lupus-like symptoms, or demyelinating disease were reported.
Conclusions: Adalimumab reduced the signs and symptoms of AS and induced partial remission for up to 2 years. The long-term safety profile was similar to the short-term safety profile.
Trial registration information: NCT00085644
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Competing interests: DvdH has received consulting fees, research grants and/or speaking fees from Abbott Laboratories, Amgen, Aventis, Bristol Meyers Squibb, Centocor, Pfizer, Roche, Schering-Plough, UCB and Wyeth. MHS has received reimbursements, speaking fees, research funds and consulting fees. JS has received consulting fees, research grants and/or speaking fees from Abbott Laboratories, Bristol Meyers Squibb, Centocor, Pfizer, Roche, Schering-Plough, UCB and Wyeth. AJK has received consulting fees, research grants and/or speaking fees from Abbott Laboratories, Amgen, Bristol Meyers Squibb, Pfizer, Roche, Novartis, Schering-Plough, UCB and Wyeth. BACD has received research grants from Abbott, Schering-Plough and Wyeth. PJM has received research grants and speaker’s bureau honorarium from Abbott Laboratories and has served as a consultant for Abbott Laboratories. JCD has received speaking fees from Abbott and served as the University of California San Francisco primary investigator for the ATLAS study. RLW and HK are employees of Abbott and own shares of Abbott stock.
Funding: The research reported here and the preparation of this manuscript were funded by Abbott Laboratories. The ATLAS Study Group included experts from academic institutions in Europe and the USA 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.
Ethics approval: Ethics approval was obtained.
Patient consent: Obtained.