Immunomodulators and "on demand" therapy with infliximab in Crohn's disease: Clinical experience with 400 infusions

OBJECTIVES: Infliximab has been proven effective for treatment of active Crohn's and fistulizing Crohn's disease. We reviewed our experience with infliximab in patients with Crohn's disease to determine if its combination with immunomodulators leads to better response and longer periods of disease quiescence. METHODS: We performed a retrospective chart review of 122 patients with Crohn's disease who received infliximab infusions. Data were collected on patient demographics, clinical response to infliximab, fistula response, prednisone dose, infusion reactions/side effects, concomitant immunomodulator therapy, and time intervals between infliximab infusions. RESULTS: Of 122 patients receiving infliximab infusions, 117 completed more than 2 wk of follow-up (400 infusions), and five patients had no follow-up. Co-therapies included azathioprine (AZA) in 47 (40.2%) patients, 6-mercaptopurine (6-MP) in 11 (9.4%), methotrexate (MTX) in 23 (19.7%), prednisone in 64 (54.7%), mesalamine in 51 (43.6%), and antibiotics in 16 (13.7%). Mean follow-up was 52 wk (14-864 days). Overall response rate to infliximab was similar between patients receiving immunomodulators (AZA/6-MP 87.9%, MTX 82.6%) and patients receiving infliximab alone (75%), although there was a trend toward higher response with AZA/6-MP (p = 0. 10). More frequent drug reactions/side effects occurred in the infliximab alone group (22.2%) compared with patients receiving MTX (13.0%) and AZA/6-MP (13.8%), but this was not statistically significant. Prednisone dosage was reduced from a mean of 19.5 mg to 7.5 mg per day overall (p < 0.05) . Fistula response and dosing intervals were not affected by concomitant immunosuppression. CONCLUSIONS: Concomitant use of immunomodulators with infliximab in patients with Crohn's disease did not improve patient response to several parameters measured, including clinical response rate, dose reduction of prednisone, fistula response, and mean intervals between infliximab infusions.