Efficacy of Infliximab in Ulcerative Colitis in a Clinical Practice Setting

Abstract

Purpose: Infliximab has recently been approved for use in moderate and severely active ulcerative colitis(UC) on the basis of two randomized controlled trials. We aim to evaluate the drug in routine practice to ascertain if outcomes are similar in everyday clinical use. Methods: We reviewed the charts of patients treated with infliximab for UC at one center over 3 years. Results: We identified 42 patients (20 male, 22 female), with an average age of 36.9 years, who received 146 infusions. The average duration of disease prior to first infusion was 7.5 years (3 months-27 years). The leading indications for infliximab use were steroid refractory or steroid dependent disease. 67% of patients were being treated with concurrent immunomodulators at baseline. 32 patients had sufficient data for follow-up of symptoms after infusion of infliximab and a modified Mayo score measuring stool frequency and rectal bleeding (range 0–6, with 6 being most severe) was calculated from data collected at baseline and follow-up visits. The mean time to follow-up after 1st infusion was 11 weeks. Sigmoidoscopy or colonoscopy was documented in 14 patients within 3 months prior to therapy; 6 had pancolitis, 6 – left sided colitis, 1 – proctitis and 1 – pouchitis. 23 patients were on steroids at time of 1st infusion at a mean dose of 24.7 mg of prednisone. At follow-up, the mean dose of steroids had decreased to 19.9mg of prednisone. 17% of patients were able to discontinue steroids. 71% of patients had a clinical response as measured by decrease in stool frequency and/or bleeding. 22% of patients were in remission as defined by normal stool frequency, absence of rectal bleeding and no use of steroids. The mean modified Mayo score decreased from 3.9 at baseline to 1.4 at follow-up. However, 22% of patients required colectomy at a mean of 43 days after 1st infusion. 12% of patients required dose escalation to maintain response. Conclusions: Our data show that the majority of patients have some improvement after infliximab. However, the important clinical endpoints of remission or steroid withdrawal occur in less than a quarter of patients. In this short term study 22% of patients required a colectomy. These findings are consistent with data obtained in larger randomized controlled studies and suggests those results can be applied to patients encountered in clinical practice.