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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/8550

Title: Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period
Authors: Braun, Juergen
Doedhar, Atul
Dijkmans, Ben
Geusens, Piet
Sieper, Joachim
Williamson, Paul
Xu, Weichun
Visvanathan, Sudha
Baker, Daniel
Goldstein, Neil
Van Der Heijde, Desiree
Issue Date: 2008
Publisher: WILEY-LISS
Abstract: Objective. To assess safety and efficacy of infliximab in patients with ankylosing spondylitis (AS) through 102 weeks. Methods. Patients (n = 279) with active AS were randomized to either group 1 (n = 78; placebo through week 24 and then infliximab 5 mg/kg from weeks 24 through 96) or group 2 (n = 201; infliximab 5 mg/kg through week 96). The primary efficacy end point at week 24 (>= 20% improvement in the Assessment in Ankylosing Spondylitis International Working Group criteria [ASAS20]) was assessed with an intent-to-treat analysis of observed data. Results. More patients in group 2 than group 1 achieved the ASAS20 response at week 24 (61.2% versus 19.2%; P < 0.001). By week 102, groups 1 and 2 were similar with regard to ASAS20 response (72.1% versus 73.9%); ASAS40 responses at week 102 were 45.9% versus 59.4%. No new safety issues were discerned. Conclusion. Infliximab demonstrated sustained efficacy and safety over 2 years in this large cohort of patients with active AS.
Notes: [Braun, Juergen] Rheumazentrum Ruhrgebiet, D-44652 Herne, Germany. [Doedhar, Atul] Oregon Hlth & Sci Univ, Portland, OR 97201 USA. [Dijkmans, Ben] Vrije Univ Amsterdam Med Ctr, Amsterdam, Netherlands. [Dijkmans, Ben] Jan Breemen Inst, Amsterdam, Netherlands. [Geusens, Piet] Univ Hasselt, Hasselt, Belgium. [Sieper, Joachim] Free Univ Berlin, Univ Klinikum Benjamin Franklin, D-1000 Berlin, Germany. [Williamson, Paul; Xu, Weichun; Visvanathan, Sudha; Baker, Daniel; Goldstein, Neil] Centocor Inc, Malvern, PA 19355 USA. [Van Der Heijde, Desiree] Leiden Univ, Ctr Med, Leiden, Netherlands.
URI: http://hdl.handle.net/1942/8550
DOI: 10.1002/art.24001
ISI #: 000259669700010
ISSN: 0004-3591
Category: A1
Type: Journal Contribution
Validation: ecoom, 2009
Appears in Collections: Research publications

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