title: Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period.
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.
  
  
  CONCLUSIONS
  Infliximab demonstrated sustained efficacy and safety over 2 years in this large cohort of patients with active AS.
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany. j.braun@rheumazentrum-ruhrgebiet.de
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.forename: Atul
authors.initials: A
authors.lastname: Deodhar
authors.forename: Ben
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authors.lastname: Dijkmans
authors.forename: Piet
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authors.lastname: Geusens
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.forename: Paul
authors.initials: P
authors.lastname: Williamson
authors.forename: Weichun
authors.initials: W
authors.lastname: Xu
authors.forename: Sudha
authors.initials: S
authors.lastname: Visvanathan
authors.forename: Daniel
authors.initials: D
authors.lastname: Baker
authors.forename: Neil
authors.initials: N
authors.lastname: Goldstein
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde