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Maintenance Infliximab for Fistulizing Crohn Disease

Infliximab maintenance treatment is effective for fistulizing Crohn disease.

Infliximab is effective as maintenance therapy for patients with Crohn disease (CD) without fistulas. In this international, multicenter, industry-supported study, researchers examined the efficacy of infliximab as maintenance therapy in 306 adult CD patients with fistulas. All patients received induction infusions of infliximab (5 mg/kg) at the start of the study and 2 and 6 weeks later; the 195 patients who had a response (>50% reduction in number of draining fistulas at two consecutive visits) to the induction regimen at both weeks 10 and 14 and the 87 patients who did not (24 patients were excluded) were then randomized to receive repeated infliximab infusions (5 mg/kg; 139 patients) or placebo (143 patients) every 8 weeks and were followed until week 54.

Patients randomized to receive infliximab maintenance who lost their response were allowed to increase infliximab infusions to 10 mg/kg (28 patients), and those randomized to receive placebo who lost their response (50 patients) were allowed to cross over to infliximab infusions of 5 mg/kg. Among patients with a response to induction therapy, 62% of patients in the placebo group, versus 42% in the infliximab group, had a loss of response after randomization. In most cases, loss of response was defined by the need to initiate antibiotics or corticosteroids. Recrudescence of fistulas occurred in 16% and 22% of infliximab and placebo recipients, respectively. The median time to loss of response was significantly longer in the infliximab group than in the placebo group (40 vs. 14 weeks). Improvement in CD activity index was significantly better in the infliximab group than in the placebo group (36% vs. 6%). Among patients who had no response to the infliximab induction regimen, there was no difference in response to maintenance treatment between those randomized to infliximab and those randomized to placebo. Adverse events in the infliximab group included one death from sepsis, one death from multisystem organ failure, and two cases of cancer, but none of these were clearly related to infliximab therapy. One patient in the placebo group developed multiple sclerosis, and 5% of all placebo and infliximab recipients had serious infections. Infusion reactions were more likely to occur in the infliximab group than in the placebo group (4% vs. 1%; P<0.001). One patient in the infliximab group developed a lupus-like syndrome.

Comment: Although these results indicate that infliximab maintenance treatment is effective for fistulizing CD, they do not prove that the benefits of maintenance therapy outweigh the lower cost and lower risk for infusion reactions associated with as-needed treatment after initial induction of remission.

— Douglas K. Rex, MD

Published in Journal Watch Gastroenterology March 17, 2004

Citation(s):

Sands BE et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004 Feb 26; 350:876-85.

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