Su1238 Anemia and Inflammatory Bowel Disease: Effects of High-Dose Intravenous Iron Treatment on Hemoglobin, Activity Index and Quality of Life

Background and aim: Infliximab (IFX) has been shown effective both for induction and maintenance of remission in moderate-to-severely active 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 a "real life" setting. Methods: data were extracted from clinical records of consecutive patients with biopsy proven UC who received at least one infusion of IFX from January 2008 to June 2012 in nine referral centers from Southern Italy. 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, mucosal healing and colectomy rate. Result: 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 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%). Indication to IFX were steroid dependence in 74.7% of patients, steroid-resistance in 23.0%, extra-intestinal complications in 2.3%. Thiopurine failure or intolerance was reported in 40.5%. 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 for loss of response 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 were 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 "daily clinical practice". 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.