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 the first year of release were prospectively registered. Disease activity was scored at initial infusion, and at 1, 3, 7, and 12 wk. Results were tabulated 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 number 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 infusion 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-mercaptopurine 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. Steroid tapering was seen in >90%, with 54% completely off steroids after a second infusion. Infusion-related reactions were seen in up to 24% of patients. The incidence of side effects did not differ if on concurrent immunomodulatory therapy.
Conclusions: Clinical experience with infliximab closely parallels the results of the controlled clinical trials, and includes steroid-sparing effects.