The Food and Drug Administration (FDA) approved a regimen of eight-week maintenance therapy with Centocor Inc.'s Remicade (infliximab) for long-term use in patients with fistulizing Crohn's disease. Although Remicade has already been approved for use in people with Crohn's disease, this study addresses the issue of long-term maintenance.

The new application included results from a trial involving 296 patients with draining fistulae, which are openings that extend through the bowel wall into nearby organs or through the surface of the skin. All patients in the trial received three doses of Remicade during a six-week period. Patients who experienced fistula response at weeks 10 and 14 were then randomized to receive a maintenance dose of Remicade or placebo at week 14 and again every eight weeks through week 46.

Those assigned to Remicade lost fistula response 40 weeks after randomization versus 14 weeks after randomization in the placebo group. At week 54, 38% of Remicade-treated patients had no draining fistulae compared with 22% of placebo-treated patients.

Dr. Jerome Boscia, Vice President of Clinical Research & Development at Centocor, says, "For many patients, Remicade can reduce the number of fistulas, while potentially reducing the need for hospitalizations, and therefore, fills a significant unmet medical need."