Document Detail

Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study.
MedLine Citation:
PMID:  21415053     Owner:  NLM     Status:  MEDLINE    
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.
I-H Song; F Heldmann; M Rudwaleit; H Haibel; A Weiss; J Braun; J Sieper
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2011-03-17
Journal Detail:
Title:  Annals of the rheumatic diseases     Volume:  70     ISSN:  1468-2060     ISO Abbreviation:  Ann. Rheum. Dis.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-04     Completed Date:  2011-07-13     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  0372355     Medline TA:  Ann Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  1108-10     Citation Subset:  IM    
Department of Rheumatology, Charité Medical University, Campus Benjamin Franklin, Berlin, Germany.
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MeSH Terms
Antirheumatic Agents / administration & dosage,  adverse effects,  therapeutic use*
Drug Administration Schedule
Epidemiologic Methods
Immunoconjugates / administration & dosage,  adverse effects,  therapeutic use*
Immunosuppressive Agents / adverse effects,  therapeutic use*
Middle Aged
Spondylitis, Ankylosing / drug therapy*
Treatment Outcome
Tumor Necrosis Factor-alpha / antagonists & inhibitors
Reg. No./Substance:
0/Antirheumatic Agents; 0/Immunoconjugates; 0/Immunosuppressive Agents; 0/Tumor Necrosis Factor-alpha; 7D0YB67S97/abatacept

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