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P487. Infliximab in moderate-to-severe ulcerative colitis: efficacy and safety in a “real life” retrospective multicenter study from southern Italy

M. Cappello1, M. Mazza1, G. Costantino2, W. Fries2, A.C. Privitera3, M. Mastronardi4, F. Bossa5, F. Castiglione6, A. Rispo6, A. Lauria7, N. Buccianti8, R. Marasco9, P.L. Almasio1, 1Gastroenterology Section, Di.Bi.Mis, Palermo, Italy, 2Messina, Medicina Interna, Messina, Italy, 3Azienda Ospedaliera per l'Emergenza, Ospedale Cannizzaro, Catania, Italy, 4IRCSS Castella Grotte (BA), UOC Gastroenterologia ed Endoscopia Digestiva, Castellana Grotte (BA), Italy, 5Casa Sollievo della Sofferenza, Gastroenterologia, San Giovanni Rotondo (FG), Italy, 6Università Federico II, Gastroenterologia, Napoli, Italy, 7A. O. Bianchi-Melacrino-Morelli, Reggio Calabria, Gastroenterologia, Reggio Calabria, Italy, 8A. O. S. Carlo, Potenza, U.O.C. di Medicina Interna, Potenza, Italy, 9Policlinico Catanzaro, UOC Gastroenterologia, Catanzaro, Italy

Background

Infliximab (IFX) has been shown effective both for induction and maintenance of remission in moderate-to-severe ulcerative colitis (UC). The aim of this retrospective multicenter study is to provide data on short and long-term efficacy and safety of IFX in UC in “daily clinical practice” patients.

Methods

All consecutive patients with UC who received at least one infusion of IFX from January 2008 to June 2012 in nine centers from Southern Italy were evaluated. Clinical and demographic characteristics, IFX indications, concomitant medications, disease activity (Mayo score), date of colectomy, and adverse events were registered. Outcomes of efficacy were clinical and endoscopic responses at week 14 and 52, steroid-free remission and colectomy rate.

Results

The study included 257 adult patients with UC (58.4% males, mean age 35.7, range 10–78) treated with scheduled IFX 5 mg/kg. Median duration of UC diagnosis was 50 months (IQR 18–115), and the extension of disease was pancolitis in 185 (72.0%) subjects, left-sided colitis in 57 (22.2%), and proctosigmoiditis in 15 (5.8%). Indications to IFX were steroid dependence in 74.7% of patients, steroid-resistance in 23.0%, extra-intestinal complications in 2.3%. Thiopurine failure was reported in 40.5% of subjects. IFX was used as rescue therapy in 5.8% of patients with severe refractory UC. Patients received a median of 9 infusions (range 1–40) and median follow-up was 26 months. IFX optimization was necessary in 39 (15.2%). Overall median Mayo score was 9 (IQR 7–10) at enrolment, 5 (IQR 2–6) at 14 weeks and 3 (IQR 1–5) at 52 weeks (p < 0.001 by Anova). Remission rates were 32% at week 14, 39.4% at week 52. The rate of patients able to stop steroids was 42.0% at 14 weeks and 40.5% at 52 weeks. Mucosal healing was obtained in 56.7%. Colectomy was performed in 22 patients (8.6%). Median time to colectomy was 7.1 months. Adverse events were observed in 51 (19.8%) of patients: 20 infusion reactions, 22 opportunistic infections (7 patients with shingles). Four subjects developed “de novo” neoplasia (2 colo-rectal carcinoma).

Conclusion

This is the first report of a large open-label multicenter Italian series in a “real life” setting. Infliximab is a safe and effective treatment in avoiding colectomy and inducing both short and long-term clinical response and mucosal healing in moderate-to-severe UC.