Gastroenterology

Gastroenterology

Volume 126, Issue 2, February 2004, Pages 402-413
Gastroenterology

Clinical-alimentary tract
Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease

https://doi.org/10.1053/j.gastro.2003.11.014Get rights and content

Abstract

Background & aims: This analysis of Crohn’s disease patients treated with infliximab in ACCENT I compared episodic and scheduled treatment strategies under conditions that simulate clinical practice. Methods: After 5 mg/kg infliximab at week 0, 573 patients were randomized to infusions at weeks 2 and 6 and every 8 weeks until week 46 of placebo (episodic), infliximab 5 mg/kg at weeks 2 and 6 followed by 5 mg/kg (5 mg/kg scheduled) every 8 weeks, or infliximab 5 mg/kg at weeks 2 and 6 followed by 10 mg/kg (10 mg/kg scheduled) every 8 weeks. At or after week 14, treatment could be given with a dose of infliximab 5 mg/kg higher upon loss of response. Results: The efficacy of scheduled infliximab therapy was better than episodic treatment. Crohn’s Disease Activity Index (CDAI) scores were consistently significantly better in the 10 mg/kg scheduled maintenance group from weeks 10 to 54, and response and remission rates (combined scheduled) were significantly higher from weeks 10 to 30. A greater proportion of patients achieved complete mucosal healing at week 54 (P = 0.041). A lower proportion developed antibodies to infliximab in the scheduled groups than in the episodic group (9% [5 mg/kg], 6% [10 mg/kg], 28% [episodic], respectively). Scheduled strategy patients had fewer Crohn’s disease-related hospitalizations (P = 0.014) and surgeries (P = 0.01) than episodic strategy patients. Conclusions: The scheduled infliximab groups, particularly the 10 mg/kg group, had better CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ) responses than those in the episodic group. Both scheduled groups had fewer hospitalizations, higher rates of mucosal healing, and fewer developed antibodies than those in the episodic group, with no increase in side effects.

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.

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