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P412 The Sicilian network of biological therapy in inflammatory bowel disease: preliminary data on efficacy

Orlando A.1, Macaluso F.S.*1, Fries W.2, Privitera A.C.3, Cappello M.4, Siringo S.5, Inserra G.6, Magnano A.7, Di Mitri R.8, Belluardo N.9, Scarpulla G.10, Magrì G.11, Trovatello N.12, Carroccio A.13, Genova S.14, Calandruccio G.15, Vassallo R.16, Romano C.17, Pellegrino S.17, Citrano M.18, Accomando S.19, Ventimiglia M.1, Renna S.1, Orlando R.1, Rizzuto G.1, Vinci E.1, Cottone M.1

1Division of Internal Medicine, “Villa Sofia-Cervello” Hospital, Palermo, Italy 2Inflammatory bowel disease Unit, A.O.U. Policlinico “G. Martino”, Messina, Italy 3IBD Unit, A.O. “Cannizzaro”, Catania, Italy 4Gastroenterology and Hepatology Unit, A.O.U. Policlinico “G. Giaccone”, Palermo, Italy 5Gastroenterology Unit, A.R.N.A.S. “Garibaldi”, Catania, Italy 6Internal Medicine Unit, A.O.U. Policlinico “Vittorio Emanuele”, Catania, Italy 7Gastroenterology Unit, A.O.U. Policlinico “Vittorio Emanuele”, Catania, Italy 8Gastroenterology and endoscopy Unit, A.R.N.A.S. “Civico Di Cristina Benfratelli”, Palermo, Italy 9Gastroenterology Unit, A.O. “Guzzardi”, Vittoria, Italy 10Gastroenterology Unit, A.O.O.R. “S. Elia- M. Raimondi”, Caltanissetta, Italy 11Gastroenterology Unit, A.O. “Santa Marta e S. Venera”, Acireale, Italy 12Surgery Unit, A.O. “Umberto I”, Siracusa, Italy 13Internal Medicine Unit, A.O. “Giovanni Paolo II”, Sciacca, Italy 14Gastroenterology and Endoscopy Unit, A.O. “S. Antonio Abate”, Trapani, Italy 15Gastroenterology Unit, A.O.O.R. “Papardo Piemonte”, Messina, Italy 16Gastroenterology and Endoscopy Unit, A.O. “Buccheri La Ferla Fatebenefratelli”, Palermo, Italy 17Pediatric Gastroenterology Unit, A.O.U. Policlinico “G. Martino”, Messina, Italy 18Pediatric Unit, A.O.O.R. “Villa Sofia-Cervello”, Palermo, Italy 19Pediatric Unit, A.O.U. Policlinico “G. Giaccone”, Palermo, Italy

Background

The monitoring of appropriateness, costs, and clinical outcomes of biological therapy in inflammatory bowel disease (IBD) is a relevant need. We aimed to evaluate all these issues in Sicily through a web based network of all prescribing centers.

Methods

From January 2013, all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data of incident cases about the efficacy of biological therapy after twelve weeks and one year of treatment.

Results

From January 2013 to October 2016, 1475 patients were included. Incident cases were 1090. Considering that 16% of patients experienced more than one line of therapy, a total of 1351 treatments were reported. Adalimumab was used in 622 Crohn's disease (CD) patients and in 83 ulcerative colitis (UC)/unclassified colitis patients. Infliximab was prescribed in 275 CD patients (80 biosimilars) and in 279 UC patients (50 biosimilars). Golimumab was used in 32 UC patients, while vedolizumab in 40 CD patients and in 20 UC patients. In patients with CD, after twelve weeks and one year of therapy, the rates of remission with adalimumab were 43.9% and 60.2%, respectively, and the rates of response 40.9% and 25.8%, while the rates of remission with infliximab originator were 46.2% and 50.0%, and the rates of response 40.9% and 32.9% (biosimilars: remission 31.0% and response 51.7% after 12 weeks; remission 45.5% and response 36.4% after one year). In UC, after twelve weeks and one year of therapy, the rates of remission with adalimumab were 43.3% and 57.1%, respectively, and the rates of response 36.7% and 19.0%; the rates of remission with infliximab originator were 41.6% and 48.4%, and the rates of response 35.6% and 32.3% (biosimilars: remission 30.0% and response 63.3% after 12 weeks; remission 20.0% and response 40.0% after one year); the rate of remission after 12 weeks of therapy with Golimumab was 22.2%, and the rate of response was 33.3%. After twelve weeks of therapy with Vedolizumab, 28.6% of CD patients were in remission and 32.0% had a response, while the rates of remission and response in UC patients were 33.3% and 22.0%, respectively. Multivariable logistic regression analysis showed that age >50 years was independently linked to lower rates of remission/response at 12 weeks in CD patients (OR 0.613, p=0.046).

Conclusion

In one of the largest series of IBD patients on biological therapy reported to date, CD patients older than 50 years showed a higher rate of non response at 12 weeks of treatment. Efficacy of biosimilars was overall comparable to that reported for infliximab originator.