Infliximab is an effective maintenance therapy for patients with Crohn's disease without fistulas. However, it is not known whether infliximab is an effective maintenance therapy for patients with fistulizing disease.
In this study, doctors from Europe and North America evaluated the efficacy of infliximab maintenance therapy in 306 adult patients with Crohn's disease. All patients had 1 or more draining abdominal or perianal fistula of at least 3 months' duration.
The patients received 5 mg of infliximab per kilogram of body weight intravenously on weeks 0, 2, and 6.
|36% of patients in the infliximab maintenance group had a complete absence of fistulas.|
|New England Journal of Medicine|
The team randomly assigned 195 patients who had a response at weeks 10 and 14 and 87 non-responding patients to receive either placebo or infliximab (5mg per kg) every 8 weeks.
Patients were followed for 54 weeks.
The team measured the time to the loss of response in patients who had a response at week 14 and underwent randomization.
They found that the time to loss of response was greater in patients who received infliximab maintenance therapy than in those who received placebo (>40 weeks versus 14 weeks).
At week 54, 19% of patients in the placebo group had a complete absence of draining fistulas, compared with 36% of patients in the infliximab maintenance group.
Dr Bruce Sands and colleagues concluded, "Patients with fistulizing Crohn's disease who have a response to induction therapy with infliximab have an increased likelihood of a sustained response over a 54-week period if infliximab treatment is continued every 8 weeks".