Efficacy and safety of repeated infliximab infusions for Crohn's disease: 1-year clinical experience

Data from clinical trials suggest the efficacy of the chimeric tumor necros is factor alpha monoclonal antibody infliximab in improving clinical, endos copic, and histologic outcomes in patients with moderately to severely acti ve Crohn's disease (CD) and fistulizing CD. To determine whether the effica cy and safety record of infliximab reported in clinical trials would be ref lected in clinical use, clinical experience with infliximab was assessed in patients with CD at the University of Chicago, Chicago, Illinois. All pati ents with CD at this institution receiving infliximab in the first year of its release were prospectively followed up for 1 year. Disease activity was scored at the time of the initial infusion and at 1, 3, 7, and 12 weeks af ter infusion. Results were analyzed separately for patients with luminal or fistulous CD. Clinical response, remission, corticosteroid tapering, and a dverse event data were collected. A total of 129 patients with luminal (n = 81) or fistulous (n = 48) disease received a mean of 2.38 and 3.23 infusio ns of infliximab per patient, respectively. After the initial infusion cour se, clinical response and remission rates at 3 weeks were 65% and 31% for p atients with luminal disease and 78% and 24% for patients with fistulous di sease, respectively. Clinical response and remission after the first infusi on occurred at a median of 8 days and 9 days, respectively. In those patien ts who subsequently relapsed, relapses occurred after a mean of 8.5 weeks a nd 12.2 weeks in patients with luminal and fistulizing disease, respectivel y. Corticosteroid tapering was possible in > 90% of patients (luminal disea se) after the initial infusion and complete withdrawal in 54% after the sec ond infusion, with a sustained median steroid dose of 0 mg from the 4-month time-point onward. Infusion reactions or adverse events occurred in 5-13% of patients during or immediately after the initial infusion of infliximab; most were mild and easily managed and did not increase in incidence with s ubsequent infusions. Clinical experience with infliximab closely mirrors th e findings of controlled clinical trials. Repeated administration of inflix imab was efficacious and relatively well tolerated in patients with CD and demonstrated corticosteroid-sparing benefits.