Comparison of Scheduled and Episodic Treatment Strategies of Infliximab in Crohn's Disease

Paul Rutgeerts*, Brian G. Feagan, Gary R. Lichtenstein, Lloyd F. Mayer, Stefan Schreiber, Jean Frederic Colombel, Daniel Rachmilewitz, Douglas C. Wolf, Allan Olson, Weihang Bao, Stephen B. Hanauer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

822 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)402-413
Number of pages12
JournalGastroenterology
Volume126
Issue number2
DOIs
StatePublished - Feb 2004

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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