Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis

Abstract

Objective: To evaluate the long-term safety and efficacy of adalimumab in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA).

Design: Patients (n = 315) with active AS were randomised in a 2:1 ratio to receive adalimumab 40 mg every other week or placebo for 24 weeks followed by open-label adalimumab for up to 5 years. Two-year efficacy and safety data for 11 patients with investigator-defined TSA were evaluated. The primary end point was the ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at Week 12. On or after Week 12, ASAS20 non-responders could switch to open-label adalimumab. Other efficacy measurements included ASAS40, ASAS 5/6, ASAS partial remission, and 50% improvement in the Bath AS Disease Activity Index (BASDAI 50).

Results: 6 of 11 TSA patients were randomised to adalimumab and 5 to placebo. At Week 12, 50% of the adalimumab-treated patients achieved an ASAS20 response and 33% achieved an ASAS40, ASAS 5/6 and BASDAI 50. No placebo-treated patients achieved any response criteria at Week 12. 4 placebo- and 2 adalimumab-treated patients switched to open-label adalimumab before Week 24. After 1 year of adalimumab treatment, 8 of 11 patients achieved an ASAS20 response. After 2 years, 6 of the remaining 8 patients with TSA reported an ASAS20 response. There were no serious adverse events or adverse event-related study discontinuations.

Conclusion: In patients with TSA, adalimumab treatment resulted in rapid and clinically significant improvement in the signs and symptoms of active disease. Adalimumab effectiveness and safety were sustained for at least 2 years.

Trial registration number: NCT00085644.

Conflict of interest statement

Competing interests: DvdH has received consulting fees, research grants and speaking fees from Abbott Laboratories, Amgen, Aventis, Bristol-Myers Squibb, Centocor, Pfizer, Roche, Schering-Plough, UCB and Wyeth. ALP is an employee of Abbott. MHS has received reimbursements, speaking fees, research funds and consulting fees from Abbott Laboratories, Amgen, Bristol-Myers Squibb, Centocor, Genetech, Roche, Targeted Genetics, UCB and Wyeth. JB has received reimbursements, fees and grants from Abbott, Schering-Plough, Wyeth, Centocor and Amgen. 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. MB, JT and EC declared no competing interests.