Clinical experience with infliximab therapy in 100 patients with Crohn's disease

OBJECTIVE: The aim of this study was to assess our clinical experience with infliximab, a monoclonal antitumor necrosis factor antibody, following its approval for treatment of refractory Crohn's disease (CD). METHODS: We followed 100 consecutive patients with CD (53 women and 47 men; mean age, 41 yr) who received a total of 233 infliximab (5 mg/kg) infusion s. Adverse events were noted and clinical response assessed every 2 wk for 6 months after each infusion using the Harvey Bradshaw Index (HBI) for acti ve disease, the Perianal Disease Activity Index (PDAI) for fistulous diseas e, and steroid withdrawal rates for steroid-sparing efficacy. RESULTS: Indications for therapy were active disease (n = 57), perianal fis tulous disease (n = 33), and steroid dependency (n = 10). Significant infus ion reactions occurred in 16 patients (6.9% of infusions) including anaphyl actic shock in one patient. Fourteen patients experienced infectious advers e events, 13 of whom were on concurrent steroids. Sixty percent of patients with active disease experienced greater than or equal to 50% HBI reduction at 2 wk; mean duration of response, 8.2 wk. Three of 26 first-time nonresp onders with active disease (12%) responded to a second infusion. Sixty-nine percent of patients with fistulous disease experienced >50% reduction in t heir PDAI at 2 wk; mean duration of response, 10.9 wk. Four of 10 steroid-d ependent patients (40%) discontinued steroid therapy, one of whom recommenc ed steroid therapy at 24 wk. CONCLUSIONS: Our clinical response rates mirror the efficacy reported in th e controlled trials for active and fistulous disease. Steroid-sparing effic acy was seen in 40% of steroid-dependent patients. Concurrent steroids did not reduce the risk of significant infusion reactions (6.9%), but did incre ase the risk of infections. (C) 2000 by Am. Cell. of Gastroenterology.