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

Jürgen Braun, Atul Deodhar, Ben Dijkmans, Piet Geusens, Joachim Sieper, Paul Williamson, Weichun Xu, Sudha Visvanathan, Daniel Baker, Neil Goldstein, Désirée Van Der Heijde

Research output: Contribution to journalArticle

88 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1270-1278
Number of pages9
JournalArthritis Care and Research
Volume59
Issue number9
DOIs
StatePublished - Sep 15 2008

ASJC Scopus subject areas

  • Rheumatology

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    Braun, J., Deodhar, A., Dijkmans, B., Geusens, P., Sieper, J., Williamson, P., Xu, W., Visvanathan, S., Baker, D., Goldstein, N., & Van Der Heijde, D. (2008). Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Care and Research, 59(9), 1270-1278. https://doi.org/10.1002/art.24001