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P445. Infliximab three-dose induction regimen in severe corticosteroid-refractory ulcerative colitis: early and late outcome and predictors of colectomy

R. Monterubbianesi1, A. Aratari2, A. Armuzzi3, M. Daperno4, L. Biancone5, M. Cappello6, V. Annese7, G. Riegler8, A. Orlando9, A. Viscido10, G.M. Meucci11, A. Gasbarrini3, L. Guidi3, A. Lavagna4, R. Sostegni4, S. Onali5, C. Papi2, A. Kohn1, 1A.O.San Camillo Forlanini, Gastroenterology Unit, Rome, Italy, 2A.O.San Filippo Neri, Gastroenterology and Hepatology Unit, Rome, Italy, 3Columbus-Gemelli Hospital, IBD Unit, Rome, Italy, 4AO Ordine Mauriziano, Gastroenterology Division, Turin, Italy, 5Tor Vergata University, Internal Medicine, Rome, Italy, 6University of Palermo, Gastroenterology Section, Palermo, Italy, 7A.O. Careggi, Gastroenterology Division, Florence, Italy, 8University of Naples, Gastroenterology Unit, Naples, Italy, 9AO Villa Sofia-Cervello, Internal Medicine, Palermo, Italy, 10University of L'Aquila, Internal Medicine, L'Aquila, Italy, 11S. Giuseppe Hospital, Gastroenterology Unit, Milan, Italy

Background

Infliximab is effective as rescue therapy in severe corticosteroid-refractory ulcerative colitis. The optimal dose regimen and the long term benefits are not well defined, and open label series with different lengths of follow up and different infliximab dose regimens report an overall colectomy rate ranging from 18% to 75%. Aim of the present study was to evaluate short- and long-term colectomy rate in a prospective cohort of patients with severe corticosteroid-refractory ulcerative colitis who received a three-dose infliximab induction regimen.

Methods

From March 2003 to October 2009 all consecutive patients admitted to 11 Italian IBD referral centres and treated with infliximab according to an intention to treat three-dose regimen were enrolled. All patients were hospitalized and were candidates for colectomy because of resistance to intensive intravenous glucocorticoid treatment. Co-primary endpoints were 3- and 12-month colectomy rate. The secondary end-points were the overall colectomy-free survival and the identification of predictors of colectomy.

Results

One hundred and thirteen patients (57% female, median age 37 years) were enrolled. The vast majority of patients had extensive colitis (70.8%) and were no smokers or ex-smokers (93%). The median duration of disease was 36 months. Eighty-one out of 113 patients (72%) had severe endoscopic activity at baseline flexible sigmoidoscopy, and 39 out of 113 (34.5%) were receiving immunosuppressant treatment at the time of hospital admission. No patient had received previous infliximab therapy. The 3- and 12-month colectomy rate were 18.6% (95% CI 11.8%-26.9%) and 25.6% (95% CI 17.9%-34.7%) respectively. High CRP values and severe endoscopic lesions were associated with the risk of colectomy: Risk Ratio (RR) = 2.15 (95% CI 1.05–4.36), and RR = 5.13 (95% CI 1.55–16.96), respectively. In patients escaping early colectomy, the probability of a colectomy-free course at 12, 24, 36 and 60 months was 91%, 85%, 81% and 73%, respectively. Endoscopic severity was the only predictor of long term colectomy (RR = 7.0; 95% CI 1.09–44.7). Adverse events occurred in 16 patients (14%); there was one death (0.88%) due to pulmonary abscess.

Conclusion

Infliximab is an effective and safe rescue therapy for severe corticosteroid-refractory ulcerative colitis. A three-dose induction regimen seems to be the treatment of choice for preventing early colectomy. Severe endoscopic lesions appears to be predictor of short- and long-term colectomy.