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

Author(s): 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

Affiliation(s): Rheumazentrum Ruhrgebiet, Herne, Germany. j.braun@rheumazentrum-ruhrgebiet.de

Publication date & source: 2008-09-15, Arthritis Rheum., 59(9):1270-8.

Publication type: Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2008-11-03

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