A prospective open-label trial of Remicade® in patients with severe exacerbation of Crohn's disease requiring hospitalization -: A comparison with outcomes previously observed in patients receiving intravenous hydrocortisone

Purpose: To evaluate treatment response to intravenous (IV) infliximab (IFX) as a first-line therapy in patients hospitalized for severe Crohn's disease and compare it with our earlier data using IV hydrocortisone. Methods: Seventeen cases received IFX (5mg/kg) and were matched for the same goal of therapy to those who had received hydrocortisone (300 mg/d). The Crohn's and Colitis Foundation of America-International Organization of Inflammatory Bowel Disease (CCFA-IOIBD) score was obtained for the IFX-treated cases on admission and daily and the Crohn's disease activity index (CDAI) score weekly throughout the hospitalization and compared with those who received hydrocortisone. Discharge was guided by the same criteria in both groups. Results: For the IFX group, the admission mean CCFA-IOIBD score was 13.5 (+/- 4.4). Eight of 17 patients achieved a clinical response with a mean score of 4 (+/- 1.5), representing a >= 50% reduction from baseline to discharge. The mean admission score for the hydrocortisone group was 17.75 (+/- 7.1) with 13 of 16 achieving a mean score of 4.5 (+/- 2.3). The mean discharge score for the 17 IFX patients was 6.9 (+/- 3) and for the hydrocortisone group was 5.9 (+/- 3.2). Median length of hospitalization for the IFX patients was 4 days (range 1 to 9) and 7.5 (5 to 15) days for the hydrocortisone group (P < 0.001). Conclusions: IFX therapy was an effective first-line agent in patients with severe Crohn's disease who require hospitalization and therefore a primary treatment option. Most patients receiving IFX can anticipate a briefer hospitalization than with IV hydrocortisone. Failure of an early response can provide an opportunity to consider an alternate form of therapy sooner with IFX than with hydrocortisone.