Clinical-alimentary tractComparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease☆
Section snippets
Patients
This multicenter, randomized, double-blind trial was carried out at 55 sites. The protocol was approved by the institutional review boards at participating sites. Written informed consent was obtained from all patients.
Eligible patients had Crohn’s disease of at least 3 months duration with a Crohn’s Disease Activity Index (CDAI)12 score between 220 and 400. Patients receiving 5-aminosalicylates, corticosteroids, or azathioprine/6-mercaptopurine (6-MP) were eligible as described previously.11
Baseline characteristics
Five hundred eighty patients were enrolled at 55 study centers (40 North America, 13 Europe, and 2 Israel) and began treatment with 5 mg/kg of infliximab at week 0. Seven patients discontinued the study prior to randomization, and, thus, data for these patients are not included in the analysis population.
At week 2, a total of 573 patients were randomly assigned to 1 of the 3 treatment strategies: episodic (188 patients), 5 mg/kg scheduled treatment (192 patients), or 10 mg/kg scheduled
Discussion
In this analysis, data from the 54-week ACCENT I trial have been evaluated to compare 3 treatment strategies that simulate current clinical practice: an episodic treatment strategy and 2 scheduled treatment strategies. Data from all patients participating, including data from responders and nonresponders, and from the entire 54-week trial, including data following crossover to episodic treatment, were included in this analysis.
When compared with the episodic treatment strategy, infliximab
Acknowledgements
The authors thank Robert Diamond, M.D., for his critical review of this manuscript; Mary Ann Thomas, R.N., B.S.N., and Mary Whitman, Ph.D., for their writing assistance; and Kamlesh Patel, M.S., for providing statistical support.
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Support for this study was provided by Centocor, Inc. The following authors have served as consultants, received honoraria, and/or received research grants from Centocor, Inc.: P. Rutgeerts, B.G. Feagan, G.R. Lichtenstein, L.F. Mayer, S. Schreiber, J.F. Colombel, D. Rachmilewitz, D.C. Wolf, and S.B. Hanauer. A. Olson and W. Bao are employees of Centocor, Inc.