P305 Effectiveness and Safety of Vedolizumab in Biologic-Naïve Patients: Real-World Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

Macaluso, F.(1);Fries, W.(2);Renna, S.(1);Viola, A.(2);Muscianisi, M.(2);Cappello, M.(3);Guida, L.(3);Siringo, S.(4);Camilleri, S.(5);Garufi, S.(5);Privitera, A.C.(6);Belluardo, N.(7);Giangreco, E.(7);Bertolami, C.(8);Vassallo, R.(9);Rizzuto, G.(1);Orlando, R.(1);Ventimiglia, M.(1);Orlando, A.(1);

(1)"Villa Sofia-Cervello" Hospital, IBD Unit, Palermo, Italy;(2)A.O.U. Policlinico "G. Martino”, IBD Unit, Messina, Italy;(3)A.O.U. Policlinico “G. Giaccone”, Gastroenterology and Hepatology Unit, Palermo, Italy;(4)A.R.N.A.S. “Garibaldi”, Gastroenterology Unit, Catania, Italy;(5)A.O.O.R. “S. Elia- M. Raimondi”, Gastroenterology Unit, Caltanissetta, Italy;(6)A.O. “Cannizzaro”, Inflammatory Bowel Disease Unit, Catania, Italy;(7)A.O. “Guzzardi”, Gastroenterology Unit, Vittoria, Italy;(8)A.O.O.R. “Papardo Piemonte”, Gastroenterology Unit, Messina, Italy;(9)A.O. “Buccheri La Ferla Fatebenefratelli”, Gastroenterology and Endoscopy Unit, Palermo, Italy Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)


Biologic-naïve patients treated with Vedolizumab (VDZ) are largely underrepresented in real-world cohorts. We performed a multicentre, observational, cohort study on the effectiveness and safety of VDZ as treatment for Crohn’s disease (CD) and ulcerative colitis (UC) among biologic-naïve subjects.


Data of consecutive biologic-naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The primary outcome was the clinical response at 14 and 52 weeks evaluated with Harvey Bradshaw Index in CD and partial Mayo score in UC.


This large, real-world, multicenter study demonstrated the effectiveness and safety of VDZ as a first-line biologic, showing high rates of clinical response and steroid-free remission at both induction and maintenance.


IFX doses higher than 5 mg/kg are needed during induction in children with IBD to facilitate the attainment of the TC target, thereby increasing the chance of long-term DR.