Drs. Braun and Brandt contributed equally to this work.
Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: An open, observational, extension study of a three-month, randomized, placebo-controlled trial†
Article first published online: 1 AUG 2003
Copyright © 2003 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 48, Issue 8, pages 2224–2233, August 2003
How to Cite
Braun, J., Brandt, J., Listing, J., Zink, A., Alten, R., Burmester, G., Golder, W., Gromnica-Ihle, E., Kellner, H., Schneider, M., Sörensen, H., Zeidler, H., Reddig, J. and Sieper, J. (2003), Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: An open, observational, extension study of a three-month, randomized, placebo-controlled trial. Arthritis & Rheumatism, 48: 2224–2233. doi: 10.1002/art.11104
Schering-Plough had no role in the study design or in the collection, analysis, or interpretation of the data. Essex Pharma, Munich, Germany, provided the study drug.
- Issue published online: 1 AUG 2003
- Article first published online: 1 AUG 2003
- Manuscript Accepted: 14 APR 2003
- Manuscript Received: 14 FEB 2003
- Schering-Plough USA, Kenilworth, NJ
Treatment of ankylosing spondylitis (AS) with infliximab, an anti–tumor necrosis factor α monoclonal antibody, was shown to be efficacious in patients with active disease during a 3-month treatment period. The purpose of this study was to evaluate the efficacy and safety of infliximab treatment of AS for a 1-year period.
This study was an open, observational, extension study of a 3-month, randomized, placebo-controlled trial. All patients who had tolerated infliximab (infliximab/infliximab group) or placebo (placebo/infliximab 12-week crossover group) therapy for 3 months entered the open extension trial (n = 65). Infliximab was administered at a dosage of 5 mg/kg every 6 weeks after the induction phase (weeks 0, 2, and 6). The primary end point was a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
At week 54, a total of 54 of the 69 patients (78%) continued to take infliximab. The intent-to-treat primary efficacy analysis at week 54 showed that 47% of patients in the infliximab/infliximab group (95% confidence interval 31–63) and 51% of the patients in the placebo/infliximab group (95% confidence interval 36–67) achieved 50% improvement in BASDAI scores. In the analysis of those who completed the study, the mean BASDAI scores improved between weeks 0 and 54 in both treatment groups: from 6.6 to 2.4 in the infliximab/infliximab group and from 6.3 to 2.6 in the placebo/infliximab group. The dosage of nonsteroidal antiinflammatory drugs was reduced in ∼70% of the patients. There were significant improvements in measures of functioning, metrologic parameters, and quality of life. Between weeks 12 and 54, a total of 4 patients had serious adverse events that were possibly related to infliximab and resulted in their discontinuing the study.
Infliximab therapy in AS patients resulted in a rapid and significant improvement in BASDAI scores (>50% improvement) and a durable response for 1 year. The safety profile of infliximab in AS was comparable to that observed in the postmarketing experience for the approved indications.