Infliximab in ulcerative colitis: real-life analysis of factors predicting treatment discontinuation due to lack of response or colectomy: ECIA (ACAD Colitis and Infliximab Study).

ABSTRACT

OBJECTIVE: To describe clinical practice with infliximab (IFX) in ulcerative colitis (UC); identification of predictive factors for IFX treatment discontinuation due to insufficient response and for colectomy. MATERIAL AND METHODS: Retrospective, multicentric and observational study including every UC IFX-treated patient in 10 Spanish hospitals. Variables analyzed epidemiological data; variables for poor prognosis; IFX prior treatments; characteristics of the IFX treatment; time from the UC diagnosis to induction with IFX; time from induction to colectomy or until data collection. Predictive and protective factors for IFX discontinuation due to lack of response and for colectomy were analyzed with binary logistic regression and Cox analysis. RESULTS: Follow-up time from induction with IFX to the collection of data or colectomy 36.7 ± 25.7 months. Prior treatment with immunomodulator medications (IMM) 79%; IFX + immunosuppressant therapy 77%; discontinuation of IFX 26%, colectomy 16%. Independent predictive or protective factors for IFX discontinuation IMM resistance (OR 2.9, p = 0.022, 95% CI 1.2-7.2), prior use of leukocytapheresis (OR 3.3, p = 0.024, 95% CI 1.1-9.4), IFX + IMM therapy (OR 0.3, p = 0.022, 95% CI 0.1-0.9, and HR 0.4, p = 0.006, 95% CI 0.2-0.8) and corticosteroid use in induction (HR 1.9, p = 0.049, 95% CI 1.0-3.8). Independent predictive or protective factors for colectomy Use of leukocytapheresis (OR 3.0, p = 0.036, 95% CI 1.1-8.4), IFX + IMM therapy (OR 0.3, p = 0.022, 95% CI 0.1-0.8, and HR 0.3, p = 0.011, 95% CI 0.1-0.8) and severe cortico-resistant flare-up (HR 2.5, p = 0.032, 95% CI 1.1-5.9). CONCLUSIONS: Prior use of IMM and leukocytapheresis, the use of corticosteroids in induction and a severe cortico-resistant flare predict a worse response to IFX and the need for colectomy. Combination therapy is a protective factor for both.