Infliximab in Crohn's disease: First anniversary clinical experience

OBJECTIVE: The aim of this study is to report on the first year experience with infliximab for Crohn's disease. METHODS: All Crohn's patients receiving infliximab at our institution in th e first year of release were prospectively registered. Disease activity was scored at initial infusion, and at 1,3,7, and 12 wk. Results were tabulate d separately for patients with luminal (L) or fistulous (F) Crohn's disease . Steroid withdrawal and adverse events were tabulated. RESULTS: One hundred twenty-nine patients were treated (81 L, 48 F). Mean n umber of infusions/patient were 2.38 L, 3.23 F. Median time to response and remission was 8 and 9 days L; 9 and 10 days F, respectively. Initial infus ion course response and remission rates at 3 wk were 65% and 31% L; 78% and 24% F, respectively. Rates were higher if concurrently treated with 6-merc aptopurine or azathioprine and improved with subsequent infusions. Relapse occurred in 78% at a mean 8.5 wk L and in 71% at a mean of 12.2 wk F. Stero id tapering was seen in >90%, with 54% completely off steroids after a seco nd infusion. Infusion-related reactions were seen in up to 24% of patients. The incidence of side effects did not differ if on concurrent immunomodula tory therapy. CONCLUSIONS: Clinical experience with infliximab closely parallels the resu lts of the controlled clinical trials, and includes steroid-sparing effects . (C) 2000 by Am. Cell. of Gastroenterology.