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P447. Infliximab in the treatment of moderate-to-severe ulcerative colitis: Results of a large multicenter Italian survey

M. Cappello1, M. Mazza1, G. Costantino2, W. Fries2, A.C. Privitera3, M. Mastronardi4, F. Bossa5, A. Rispo6, F. Castiglione6, A. Lauria7, N. Buccianti8, R. Marasco9, L. Grossi10, M.B. Principi11, 1University of Palermo, Gastroenterology Section, DiBiMis, Palermo, Italy, 2University of Messina, Dipartimento di Medicina Interna e Terapia Medica, Messina, Italy, 3Ospedale Cannizzaro, Catania, Azienda Ospedaliera per l'Emergenza, Catania, Italy, 4IRCCS, Castellana Grotte (BA), UOC Gastroenterologia ed Endoscopia Digestiva, Castellana Grotte (BA), Italy, 5Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Gastroenterologia, S. Giovanni Rotondo (FG), Italy, 6Università Federico II, Napoli, Gastroenterologia, Napoli, Italy, 7A. O. Bianchi-Melacrino-Morelli, Reggio Calabria, Gastroenterologia e Endoscopia Digestiva, Reggio Calabria, Italy, 8A.O.S. Carlo, Potenza, U.O.C. di Medicina Interna, Potenza, Italy, 9Policlinico Catanzaro, UOC Gastroenterologia, Catanzaro, Italy, 10Ospedale Spirito Santo, Pescara, Fisiopatologia Digestiva, Pescara, Italy, 11Policlinico, Bari, Gastroenterologia, Bari, Italy

Background

Infliximab (IFX) has been proven effectivein RCTs both for induction of remission and maintenance in moderate-to-severe ulcerative colitis (UC). The aim of this study is to provide data on IFX efficacy in UC in everyday clinical practice.

Methods

Eleven referral and non-referral centers from Southern Italy participated in the study. All patients with UC who received at least one infusion of IFX from January 2008 to June 2012 were recruited. Clinico-demographic characteristics, IFX indications, concomitant therapy anddisease activity were registered. Outcomes evaluated were clinical and endoscopic responses at week 14 and 52, steroid-free remission, colectomy rate.

Results

319 patients (60.2% males, mean age 35.4) were enrolled. Extent of disease was pancolitis in 67.1%, left-sided colitis in 24.8%, proctosigmoiditis in 8.2%. Median duration of disease was 51 months. Median follow-up was 23 months. Indication to IFX were steroid dependence in 75.3%, steroid-resistance in 16.9%, extra-intestinal complications in 2.2%, rescue therapy for severe refractory UC in 5.6%. Patients received a median of 10 (range 5–16) infusions. Mayo score was 8.3 at enrolment, 4.3 at 14 weeks and 3.2 at 52 weeks (p < 0.001). Steroids were used in 93.5% at baseline, 44.4% at week 14 and 26% at week 52. Mucosal healing was obtained in 77.3%. Colectomy rate was 8.3%. Median time to colectomy was 5 months. Results were compared in steroid dependent versus steroid-resistantpatients, IFX monotherapyversus combo and long-lasting versus recent disease. Colectomy rate was significantly higher in steroid-resistant (p = 0.0003) patients; steroid-free remission was less common in long-lasting disease.

Conclusion

Infliximab is effective in inducing short and long-term clinical response, mucosal healing, steroids sparing and in reducing colectomy rate in moderate-to-severe UC. Steroid-dependent disease is the most frequent indication in the “real-life” with favourable outcomes and a lower rate of colectomy.