P613 Comparative objective effectiveness of vedolizumab and ustekinumab in a real-life cohort of active Crohn’s disease patients failure to TNF inhibitors.

Onali, S.(1);Pugliese, D.(2);Caprioli, F.A.(3);Orlando, A.(4);Biancone, L.(5);Nardone, O.M.(6);Imperatore, N.(7);Fiorino, G.(8);Cappello, M.(9);Viola, A.(10);Principi, M.B.(11);Bezzio, C.(12);Aratari, A.(13);Carparelli, S.(14);Mazzuoli, S.(15);Manguso, F.(7);Grossi, L.(16);Bodini, G.(17);Ribaldone, D.(18);Mocci, G.(19);Minerba, L.(20);Favale, A.(21);Grova, M.(22);Scucchi, L.(23);Segato, S.(24);Fries, W.(25);Castiglione, F.(26);Armuzzi, A.(2);Fantini, M.C.(27);

(1)Università degli Studi di Cagliari, Scienze Mediche e Sanità Pubblica, Cagliari, Italy;(2)CEMAD – IBD UNIT - Unità Operativa Complessa di Medicina Interna e Gastroenterologia 2- Dipartimento di Scienze Mediche e Chirurgiche- Fondazione Policlinico Universitario "A. Gemelli" IRCCS- Rome- Italy., Dipartimento Universitario di Medicina e Chirurgia Traslazionale- Università Cattolica del Sacro Cuore., Roma, Italy;(3)Università degli Studi di Milano- Italy. Gastroenterology and Endoscopy Unit- Fondazione IRCCS Cà Granda- Ospedale Maggiore Policlinico di Milano- Italy, Department of Pathophysiology and Transplantation-, Milano, Italy;(4)IBD UNIT "Villa Sofia Cervello" Hospital- Palermo- Italy, ibd unit, palermo, Italy;(5)- University of Rome “ Tor Vergata”- Rome- Italy, Department of Systems Medicine, roma, Italy;(6)AOU Federico II Napoli- Italy, Department of Clinical Medicine and Surgery-, Napoli, Italy;(7)AORN A. Cardarelli of Naples- Italy, Gastroenterology and Endoscopy Unit, Napoli, Italy;(8)Humanitas University- Pieve Emanuele- Milan- Italy, Department of Biomedical Sciences, Milano, Italy;(9)University of Palermo- Sicily- Italy, IBD Clinic- Gastroenterology Section- Promise, Palermo, Italy;(10)University of Messina- Italy, IBD-Unit- Department. of Clinical and Experimental Medicine, Messina, Italy;(11)Policlinico-Università Bari- Italy, Gastroenterology Section D.E.T.O., Bari, Italy;(12)Asst Rhodense- Rho - Milan - Italy, Gastroenterology Unit, Milano, Italy;(13)Ospedale San Filippo Neri- Rome- Italy, Unità operativa semplice IBD, Roma, Italy;(14)Fondazione Casa Sollievo della Sofferenza - IRCCS - San Giovanni Rotondo- Italy, UOC di Gastroenterologia ed Endoscopia Digestiva, San Giovanni Rotondo, Italy;(15)Ospedale “Mons Raffaele Dimiccoli”- Barletta- Italy, UOC di Gastroenterologia-, Barletta, Italy;(16)G d'Annunzio University DSMOB Ospedale Spirito Santo Pescara- Italy, Gastroenterology Unit, Pescara, Italy;(17)Policlinico San Martino- Università degli studi di Genova- Genova- Italy, Gastroenterology Units-, Genova, Italy;(18)Università degli Studi di Torino- Italy, Dipartimento di Scienze Mediche, Torino, Italy;(19)G. Brotzu- Cagliari- Italy, Gastroenterologia ARNAS, Cagliari, Italy;(20)Università di Cagliari, Dip.Statistica Medica, Cagliari, Italy;(21)Università di Cagliari, UOC Gastroenterologia, Cagliari, Italy;(22)"Villa Sofia Cervello" Hospital-- Italy, IBD unit, Palermo, Italy;(23)University of Rome “ Tor Vergata”- Italy, Department of Systems Medicine-, Rome-, Italy;(24)Ospedale di Circolo e Fondazione Macchi –, Gastroenterologia ed Endoscopia Digestiva -, Varese, Italy;(25)University of Messina- Italy, IBD-Unit- Department. of Clinical and Experimental Medicine-, Messina, Italy;(26)AOU Federico II Napoli- Italy, Gastroenterology- Department of Clinical Medicine and Surgery, Napoli, Italy;(27)Università di Cagliari, Departement of Medical Science and Public Health, Cagliari, Italy;


The use of ustekinumab (UST) and vedolizumab (VDZ) as second line therapy in Crohn’s disease (CD) patients failing tumour necrosis factor alpha inhibitors is still debated. The aim of the study was to compare in a large multicentre observational retrospective cohort, the effectiveness of UST and VDZ as second line therapy as assessed by clinical and objective outcomes including endoscopy and gastro intestinal (GI)-imaging.


Clinical response, remission and steroid-free remission at week 26 and 52 were evaluated in a retrospective cohort of CD patients previously experienced TNF-alpha inhibitors (primary or secondary failure, and intolerant). Objective response and remission were evaluated by one or more techniques including ileocolonoscopy, magnetic resonance (MR)/computer tomography (CT) enteroclysis and small bowel ultrasound (US) performed within 3 months before the beginning of the treatment and after one year of therapy. Inverse propensity of treatment weighting (IPTW) and propensity score matching (PMS) methods were used for statistical analysis.


470 CD patients (239 UST and 231 VDZ) were included in the study. At week 26 clinical response, clinical remission and steroid free remission were similar between the two groups (Figure 1) At week 52, clinical remission and steroid-free remission rates were significantly higher in VDZ-treated patients (clinical remission: UST 42.5% vs VDZ 55.5%, p=0.01; steroid-free clinical remission UST 40.6% vs VDZ 51.1%, p=0.038; Figure 1). 302 patients (135 UST and 167 VDZ) had objective evaluation of disease activity at baseline and week 52. At week 52 objective response and remission rates were similar between the groups. (Figure 2). Clinical response at week 26 predicted steroid-free remission at week 52 in both UST- and VDZ-treated patients. Safety profiles were similar between the two groups.


One-year treatment with VDZ was associated with higher rate of clinical remission as compared to UST, but no difference was observed between the two groups when objective outcomes were investigated