Long-term outcome after infliximab for refractory ulcerative colitis

Infliximab (IFX) has been shown efficacious for moderate-to-severe ulcerative colitis (UC), but data on long-term efficacy are lacking. We investigated long-term outcome including colectomy rates in outpatients treated with IFX for refractory UC in a single referral centre, and evaluated if predictors could be identified.

The first 121 outpatients (median age 38.0 years) with refractory UC treated with IFX were included. The primary outcome was colectomy-free survival. Secondary measures were sustained clinical response and serious adverse events.

From the 81 patients (67%) with an initial clinical response to IFX, 68% had a sustained clinical response. No independent predictors of sustained clinical response could be identified. Over a median (IQR) follow-up period of 33.0 (17.0-49.8) months, 21 patients (17%) came to colectomy. Independent predictors of colectomy were absence of short-term clinical response [Hazard ratio 10.8 (95% CI 3.5-32.8), p<0.001], a baseline CRP level ≥5 mg/L [Hazard ratio 14.5 (95% CI 2.0-108.6), p=0.006] and previous IV treatment with corticosteroids and/or cyclosporine [Hazard ratio 2.4 (95% CI 1.1-5.9), p=0.033]. Six patients developed a serious infection, three a malignancy, two a post-operative complication and one patient died (suicide).

With a median follow-up of 33.0 months after start of IFX, 17% of patients with refractory UC needed colectomy, while sustained clinical response was present in 68% of initial responders.