Rita Monterubbianesi1, Annalisa Aratari2, Alessandro Armuzzi3, Marco Daperno4, Livia Biancone5, Maria Cappello6, Vito Annese7, Gabriele Riegler8, Ambrogio Orlando9, Angelo Viscido10, Gianmichele Meucci11, Antonio Gasbarrini12, Luisa Guidi13, Alessandro Lavagna14, Raffaello Sostegni15, Sara Onali16, Claudio Papi17, Anna Kohn18. 1. Gastroenterology Unit, S. Camillo-Forlanini Hospital, Rome, Italy. Electronic address: rita.monterubbianesi@gmail.com. 2. Gastroenterology & Hepatology Unit, S. Filippo Neri Hospital, Rome, Italy. Electronic address: aalisa@tin.it. 3. IBD Unit, Columbus-Gemelli Hospital, Catholic University, Rome, Italy. Electronic address: alearmuzzi@yahoo.com. 4. Gastroenterology Division, AO Ordine Mauriziano, Turin, Italy. Electronic address: mdaperno@teletu.it. 5. Department of Internal Medicine, "TorVergata" University, Rome, Italy. Electronic address: biancone@med.uniroma2.it. 6. Gastroenterology Section, Di.Bi.Mis, University of Palermo, Palermo, Italy. Electronic address: cmarica@tin.it. 7. Division of Gastroenterology, Dept. of Medical & Surgical Sciences, University Hospital Careggi, Florence, Italy. Electronic address: annesev@aou-careggi.toscana.it. 8. Gastroenterology Unit, University of Naples, Naples, Italy. Electronic address: gabriele.riegler@unina2.it. 9. Dept. of Internal Medicine, AO Villa Sofia-Cervello, Palermo, Italy. Electronic address: ambrogiorlando@gmail.com. 10. Gastroenterology Unit, Department of Internal Medicine and Public Health, University of L'Aquila, L'Aquila, Italy. Electronic address: angviscido@yahoo.it. 11. Gastroenterology Unit, S. Giuseppe Hospital, Milan, Italy. Electronic address: g.meucci@teletu.it. 12. IBD Unit, Columbus-Gemelli Hospital, Catholic University, Rome, Italy. Electronic address: agasbarrini@rm.unicatt.it. 13. IBD Unit, Columbus-Gemelli Hospital, Catholic University, Rome, Italy. Electronic address: lguidi@rm.unicatt.it. 14. Gastroenterology Division, AO Ordine Mauriziano, Turin, Italy. Electronic address: alexlava@me.com. 15. Gastroenterology Division, AO Ordine Mauriziano, Turin, Italy. Electronic address: mdaperno@gmail.com. 16. Department of Internal Medicine, "TorVergata" University, Rome, Italy. Electronic address: sara.onali@uniroma2.it. 17. Gastroenterology & Hepatology Unit, S. Filippo Neri Hospital, Rome, Italy. Electronic address: c.papi@sanfilipponeri.roma.it. 18. Gastroenterology Unit, S. Camillo-Forlanini Hospital, Rome, Italy. Electronic address: akohn@scamilloforlanini.rm.it.
Abstract
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. The aim of the present study was to evaluate short- and long-term colectomy rate in a cohort of patients with severe corticosteroid-refractory ulcerative colitis who received a three-dose infliximab induction regimen. METHODS: One hundred and thirteen patients admitted to 11 Italian IBD referral centres and treated with infliximab according to an intention to treat three-dose regimen were included. The 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: The 3- and 12-month colectomy rates 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 60months 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. CONCLUSIONS: 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 appear to be predictor of short- and long-term colectomy.
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. The aim of the present study was to evaluate short- and long-term colectomy rate in a cohort of patients with severe corticosteroid-refractory ulcerative colitis who received a three-dose infliximab induction regimen. METHODS: One hundred and thirteen patients admitted to 11 Italian IBD referral centres and treated with infliximab according to an intention to treat three-dose regimen were included. The 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: The 3- and 12-month colectomy rates 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 60months 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. CONCLUSIONS: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 appear to be predictor of short- and long-term colectomy.
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059
Authors: Matthew C Choy; Dean Seah; David M Faleck; Shailja C Shah; Che-Yung Chao; Yoon-Kyo An; Graham Radford-Smith; Talat Bessissow; Marla C Dubinsky; Alexander C Ford; Leonid Churilov; Neville D Yeomans; Peter P De Cruz Journal: Inflamm Bowel Dis Date: 2019-06-18 Impact factor: 5.325
Authors: Nienke Z Borren; Hamed Khalili; Jay Luther; Francis P Colizzo; John J Garber; Ashwin N Ananthakrishnan Journal: Inflamm Bowel Dis Date: 2019-03-14 Impact factor: 5.325
Authors: Christopher Ma; Candace L Beilman; Vivian W Huang; Darryl K Fedorak; Karen Wong; Karen I Kroeker; Levinus A Dieleman; Brendan P Halloran; Richard N Fedorak Journal: Can J Gastroenterol Hepatol Date: 2016-07-11