Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study.

Abstract

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.

• Authors: I-H Song, F Heldmann, M Rudwaleit, H Haibel, A Weiss, J Braun, J Sieper
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 70 Issue 6 Pg. 1108-10 (Jun 2011) ISSN: 1468-2060 [Electronic] England
• PMID: 21415053 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Immunoconjugates
• Immunosuppressive Agents
• Tumor Necrosis Factor-alpha
• Abatacept

Topics

• Abatacept
• Adult
• Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use)
• Drug Administration Schedule
• Epidemiologic Methods
• Female
• Humans
• Immunoconjugates (administration & dosage, adverse effects, therapeutic use)
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Male
• Middle Aged
• Spondylitis, Ankylosing (drug therapy)
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)