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.
Trial registration: ClinicalTrials.gov NCT00207701.