Objective To prospectively explore the short-term efficacy and safety of abatacept in patients with ankylosing spondylitis (AS).
Methods In this prospective open-label pilot study, abatacept (10 mg/kg) was administered intravenously on days 1, 15, 29 and every 28 days thereafter up to week 24 in 15 tumour necrosis factor α (TNFα)-inhibitor naive patients (group 1) and 15 patients with inadequate response to TNFα inhibitors (group 2) with active AS. The primary end point was the proportion of patients with 40% improvement according to the Assessment of SpondyloArthritis international Society criteria (ASAS40) in both groups at week 24.
Results At week 24, ASAS40 was reached by 13% of group 1 and 0% of group 2; 20% improvement (ASAS20) was reached by 27% and 20%, respectively. There was no significant change of Bath Ankylosing Spondylitis Disease Activity Index score, patient global assessment or C reactive protein. Overall, abatacept was well tolerated.
Conclusions In this pilot open-label AS study a major response was not observed.
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Funding This study was supported by an unrestricted grant from Bristol-Myers Squibb.
Competing interests I-HS and HH: consulting fees or other remuneration from Wyeth/Pfizer Pharmaceuticals, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals. FH: consulting fees or other remuneration from Merck Sharp Dohme/Schering Plough. MR, JB and JS: Wyeth/Pfizer, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals, UCB. AW: none.
Ethics approval Approval was obtained from the local ethics committee (Landesamt für Gesundheit und Soziales, Geschäftsstelle der Ethik-Kommission des Landes Berlin, Sächsische Straße 28, 10707 Berlin, Germany).
Provenance and peer review Not commissioned; externally peer reviewed.