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P255. Long-term infliximab treatment in Crohn's disease – Efficacy and safety

W. Fries1, A.C. Privitera2, A. Belvedere1, M. Mastronardi3, M. Cappello4, L. Grossi5, A. Lauria6, M. Principi7, N. della Valle8, N. Buccianti9

1Dept. of Internal Medicine, University of Messina, Messina, Italy; 2Dip di Scienze Chirurgiche, University of Catania, Catania, Italy; 3UOC Gastroenterologia ed Endoscopia Digestiva, IRCCS, Castellana Grotte (BA), Italy; 4Gastroenterologia ed Epatologia, Policlinico, Università di Palermo;, Palermo, Italy; 5Unità di Fisiopatologia Digestiva, Università di Chieti-Pescara, Pescara, Italy; 6Gastroenterologia e Endoscopia Digestiva, AO Bianchi-Melacrino-Morelli, Reggio Calabria, Italy; 7Gastroenterologia ed Endoscopia Digestiva, Università di Bari, Bari, Italy; 8Gastroenterologia, Università di Foggia, Foggia, Italy; 9UOC di Medicina Interna, AO S. Carlo, Potenza, Italy

The biologic agent Infliximab is widely used in Italy for therapy of Crohn's disease (CD). Clinical observations on treatment success and safety are mainly limited to 1 year. The aim of this study was to evaluate the clinical and endoscopic response to infliximab (Ifx) and safety in patients treated longer than 2 years.

Methods: Data from 9 centres of Southern Italy were analyzed retrospectively. We identified patients with more than 2 years treatment and extracted demographics, Harvey-Bradshaw index (HBI), C-reactive protein (CRP) levels, indications for treatment, surgery, concomitant therapies, and endoscopy, before Ifx therapy and at 1, 2, and 3 years; adverse events (AE) and withdrawal of therapy were recorded. Data are mean values ± SD or median (range).

Results: We identified 91 patients (M 54; mean age 37 yrs ± 8) with 15 or more infusions. The patients received together 1851 single infusions (median infusions/patient: 24); median duration of disease was 6 years (range 0.5–23 yrs); Twenty-six out of 91 had undergone at least 1 surgical resection. After Ifx start HBI dropped from 10.5±4.1 (before treatment) to 2.6±0.9 at 1 year, 2.7±0.7 at 2 years, and 2.9±1.2 at 3 years (all: p < 0.001 vs pre-treatment). Prior to Ifx 62/91 patients were on steroids (68%), 57 patients were off steroids at 1 year (p < 0.001). Statistically significant steroid-free treatment was maintained at 2 and at 3 years. Endoscopic evaluation was available from 80/91 before treatment classifying arbitrarily 19 patients as severe and 37 as moderate. Endoscopy after 2 years of treatment was available in 48/91 showing endoscopic healing in 24 (26%), partial healing in 21 (23%) and no healing in 13 patients (14%). Dose optimization (dose increase or interval reduction) was needed in 13/91 (18%) at least at one time-point. Treatment was stopped in 28 patients (31%) (14 loss of response, 4 intolerance, 2 severe infections, 2 adverse events, 1 Guillain-Barré syndrome, 3 arbitrary, 1 lost to follow-up, 1 death due to car injury); mild AE were seen in 13 patients (6 infusion reactions, 7 infections).

Conclusions: In this real live experience long term scheduled Ifx therapy showed clinical efficacy by maintaining clinical steroid-free remission. Endoscopic healing or improvement were observed in approximately half of the patients. Severe therapy-related AEs were observed in 9 (10%) patients leading to withdrawal of the biologic agent.