Long-term infliximab maintenance therapy for ulcerative colitis: The ACT-1 and -2 extension studies
Article first published online: 11 APR 2011
Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 18, Issue 2, pages 201–211, February 2012
How to Cite
Reinisch, W., Sandborn, W. J., Rutgeerts, P., Feagan, B. G., Rachmilewitz, D., Hanauer, S. B., Lichtenstein, G. R., de Villiers, W. J.S., Blank, M., Lang, Y., Johanns, J., Colombel, J. F., Present, D. and Sands, B. E. (2012), Long-term infliximab maintenance therapy for ulcerative colitis: The ACT-1 and -2 extension studies. Inflamm Bowel Dis, 18: 201–211. doi: 10.1002/ibd.21697
- Issue published online: 10 JAN 2012
- Article first published online: 11 APR 2011
- Manuscript Received: 31 JAN 2011
- Manuscript Accepted: 31 JAN 2011
- ulcerative colitis;
- long-term maintenance therapy;
- ACT extension study
The aim was to evaluate long-term efficacy, quality of life, and safety in ulcerative colitis patients who received infliximab during the ACT-1 and -2 extension studies.
Adults with moderate-to-severely active ulcerative colitis in the 54-week ACT-1 and 30-week ACT-2 studies who achieved benefit from infliximab were eligible to participate in extension studies and receive up to 3 additional years of therapy. Patients received randomized study medication until all sites were unblinded; placebo-treated patients were discontinued. Patients receiving 5 or 10 mg/kg infliximab continued to receive open-label infliximab every 8 weeks. Patients receiving infliximab 10 mg/kg could decrease to 5 mg/kg; patients receiving infliximab 5 mg/kg could increase to 10 mg/kg if response was lost.
A total of 229 of 484 infliximab-treated patients from the ACT-1 and ACT-2 main studies entered the long-term extensions. Overall, 70 (30.6%) patients discontinued infliximab infusions for adverse events (24 [10.5%]), lack of efficacy (11 [4.8%]), required a colectomy (1 [0.4%]), or for other reasons (34 [14.8%]). Proportions of patients whose Physician's Global Assessment scores were indicative of no or mild disease (score = 0 or 1) were maintained during the extension studies; 76.5% at Extension week 0 and ranged between 90.0% and 94.3% through Extension week 152. Improvement in Inflammatory Bowel Disease Questionnaire scores observed in the main studies was maintained. During the long-term extension, the infliximab safety profile was consistent with that of the main studies; no new or unexpected safety signals were observed.
Long-term treatment with infliximab for up to 3 additional years was effective and well tolerated. (Inflamm Bowel Dis 2011;)