Maintenance infliximab does not result in increased abscess development in fistulizing Crohn's disease: results from the ACCENT II study
Article first published online: 30 MAR 2006
Alimentary Pharmacology & Therapeutics
Volume 23, Issue 8, pages 1127–1136, April 2006
How to Cite
SANDS, B. E., BLANK, M. A., DIAMOND, R. H., BARRETT, J. P. and VAN DEVENTER, S. J. (2006), Maintenance infliximab does not result in increased abscess development in fistulizing Crohn's disease: results from the ACCENT II study. Alimentary Pharmacology & Therapeutics, 23: 1127–1136. doi: 10.1111/j.1365-2036.2006.02878.x
- Issue published online: 30 MAR 2006
- Article first published online: 30 MAR 2006
- Publication data Received 5 December 2005 First decision 21 December 2005 Resubmitted 5 February 2006 Accepted 6 February 2006
Background Rapid fistula healing may predispose Crohn's disease patients to abscess development.
Aim Data from ACCENT II were analysed to determine whether fistula-related abscess development is affected by infliximab exposure.
Methods Following infliximab 5 mg/kg infusions at weeks 0, 2 and 6, patients were evaluated for fistula response for two consecutive visits at least 4 weeks apart. Patients (N = 282) were randomized at week 14 to either placebo or infliximab 5 mg/kg every 8 weeks through week 46. If response was lost at or after week 22, patients could crossover to a 5 mg/kg higher infliximab dose. Fistula-related abscesses were diagnosed by physical examination or by imaging procedures according to usual practice.
Results Infliximab exposure was approximately twofold higher for the infliximab maintenance group. Twenty-one (15%) patients in the infliximab maintenance group had at least one newly developed fistula-related abscess compared with 27 (19%) in the placebo maintenance group (P = 0.526). The proportion of patients with a new fistula-related abscess was similar regardless of whether or not patients crossed over to a 5 mg/kg higher infliximab dose. The number of fistula-related abscesses diagnosed over time did not differ between groups.
Conclusion Abscess development in patients with fistulizing Crohn's disease is not dependent on cumulative infliximab exposure.