Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease

Stephen B. Hanauer*, Carrie L. Wagner, Mohan Bala, Lloyd Mayer, Suzanne Travers, Robert H. Diamond, Allan Olson, Warren Bao, Paul Rutgeerts

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

570 Scopus citations


Background & Aims: The effect of different treatment regimens on antibody responses to infliximab and their clinical significance was examined by using data from ACCENT I. Methods: Patients with Crohn's disease (n = 573) received 5 mg/kg infliximab (week 0) and then were randomly assigned to blinded infusions at weeks 2 and 6 and every 8 weeks until week 46 of placebo (group I), 5 mg/kg infliximab (group II), or 5 mg/kg infliximab at weeks 2 and 6, followed by 10 mg/kg thereafter (group III). At week 14 or later, patients losing response could cross over to episodic infliximab treatment increased by 5 mg/kg. Samples for antibody determination were collected before the first infusion and at weeks 14, 22, 54, 62, 72, and, if applicable, before and after crossover. Results: Through week 72, antibodies to infliximab were detected in 30%, 10%, and 7% of groups I, II, and III, respectively (P < 0.0001). Patients receiving immunomodulators had a lower incidence of antibodies compared with patients receiving infliximab alone (10% and 18%, respectively; P = 0.02). Antibodies were associated with a 12% absolute increase in infusion reactions but no increase in serious infusion reactions or serum sickness - like reactions. In the overall population, similar proportions of antibody-positive and antibody-negative patients achieved clinical response (64% and 62%, respectively; P = NS) or clinical remission (41% and 39%, respectively; P = NS) at week 54. Notably, 86% of patients responded to retreatment, and 63% were in clinical response at week 54; however, fewer antibody-positive group I patients attained clinical remission (31%) compared with those who were antibody negative (37%) or antibody inconclusive (54%) (P = NS). Conclusions: Reduced antibody formation and greater clinical benefit were observed with an induction regimen followed by maintenance treatment compared with a single dose followed by episodic retreatment in Crohn's disease patients treated with infliximab.

Original languageEnglish (US)
Pages (from-to)542-553
Number of pages12
JournalClinical Gastroenterology and Hepatology
Issue number7
StatePublished - Jul 1 2004


  • 6-MP
  • 6-mercaptopurine
  • ACR20/50
  • American College of Rheumatology definition of 20% or 50% improvement
  • a Crohn's disease clinical trial evaluating infliximab in a new long-term treatment regimen in patients with Crohn's disease

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


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