Retreatment and maintenance therapy with infliximab in fistulizing Crohn's disease.

OBJECTIVES: Infliximab has clearly demonstrated its efficacy in the short-term treatment of fistulizing Crohn's disease. We present here the results of retreatment and long-term maintenance therapy. PATIENTS AND METHODS: Eighty one consecutive patients with active fistulizing Crohn's disease, in whom previous treatments had failed, were treated with infliximab. All patients received as the initial treatment of 5 mg/kg i.v. infusions (weeks 0, 2, and 6). Those patients who failed to respond after the initial cycle (group 1, n = 25), or those who relapsed after having responded (group 2, n = 13), received retreatment with three similar doses (weeks 0,2, and 6). Those who responded to retreatment were included in a long-term maintenance programme (n = 44), with repeated doses (5 mg/kg i.v. infusions) every eight weeks for 1-2 years. RESULTS: In the initial treatment 56% of the patients responded partially; this response being complete in 44%. In the retreatment, 28% of group 1 (non-responders) presented a complete response, compared to 77% in group 2 (relapsers) (p < 0.0001). In the maintenance treatment, the global response was 88% (39/44). The mean number of doses per patient was 4.4 +/- 2 (range 1-9) with a duration of 36 +/- 12 weeks (range 8-72). Adverse effects were not significantly increased in either treatment. CONCLUSIONS: Both retreatment and long-term maintenance therapy with infliximab, are highly effective and well tolerated in fistulizing Crohn's disease patients.

Infliximab improves quality of life in the short-term in patients with fistulizing Crohn's disease in clinical practice.

OBJECTIVES: To assess the effect of infliximab on quality of life in a series of patients with fistulizing Crohn's disease. PATIENTS AND METHODS: A prospective observational study was made. A total of 25 patients with single or multiple draining abdominal or perianal fistulas were selected for the study. All received an intravenous infusion of infliximab at a dose of 5 mg per kilogram of body weight in weeks 0, 2, and 6. The clinical activity was calculated every two weeks over a 10-week follow-up. HRQOL (SF-36 and IBDQ scores) were compared at baseline and at weeks 4 and 10. RESULTS: Sixty-four percent of patients had a clinical response to treatment with infliximab, with complete closure of fistulas. The mean values of CDAI decreased during follow-up, with a significant difference between weeks 0 and 10 (p < 0.01). Health-related quality of life (HRQOL), as measured by means of SF-36, showed an overall improvement in the physical domain (PCS) after 4 and 10 weeks (p < 0.05). An increase was also observed in IBDQ overall score on comparing the results obtained at week 0 and week 4 (p < 0.01). The social functioning domain of IBDQ was not significantly changed with treatment. CONCLUSIONS: Treatment with infliximab in active fistulizing Crohn's disease results in a significant increase in the quality of life of patients at short-term.