Arthritis Rheum. 2008 Sep 15;59(9):1270-8.

Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period.

Braun J, Deodhar A, Dijkmans B, Geusens P, Sieper J, Williamson P, Xu W, Visvanathan S, Baker D, Goldstein N, van der Heijde D; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group.

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Rheumazentrum Ruhrgebiet, Herne, Germany. j.braun@rheumazentrum-ruhrgebiet.de

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 (>or=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.

PMID:: 18759257; [PubMed - indexed for MEDLINE]

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