P583 Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn’s disease: results from a large Italian cohort study

Mocci, G.(1);Cuomo, A.(2);Allegretta, L.(3);Aragona, G.(4);Colucci, R.(5);Della Valle, N.(6);Ferronato, A.(7);Forti, G.(8);Gaiani, F.(9);Graziani, M.G.(10);Lorenzetti, R.(11);Luzza, F.(12);Penna, A.(13);Pica, R.(14);Piergallini, S.(15);Rodinò, S.(16);Scarcelli, A.(17);Zampaletta, C.(18);Cicerone, C.(19);Cocco, A.(20);De Angelis, G.(9);Donnarumma, L.(2);Pranzo, G.(21);Franceschi, M.(7);Gallina, S.(18);Grasso, G.(3);Larussa, T.(12);Luppino, I.(22);Faggiani, R.(23);Fanigliulo, L.(24);Pagnini, C.(10);Perazzo, P.(4);Sacco, R.(6);Sebkova, L.(16);Serio, M.E.(25);De Monti, A.(26);Picchio, M.(27);Elisei, W.(28);Maconi, G.(26);Tursi, A.(29);

(1)Gastroenterology Unit, Internal Medicine- Brotzu Hospital, Cagliari, Italy;(2)Division of Gastroenterology, Umberto I” Hospital, Nocera Inferiore, Italy;(3)Division of Gastroenterology, "Santa caterina Novella" Hospital, Galatina, Italy;(4)Division of Gastroenterology, "Guglielmo da Saliceto" Hospital, Piacenza, Italy;(5)Digestive Endoscopy Unit, "San Matteo degli Infermi" Hospital, Spoleto, Italy;(6)Division of Gastroenterology, "Ospedali Riuniti" Hospital, Foggia, Italy;(7)Digestive Endoscopy Unit, ULSS7 Pedemontana, Santorso, Italy;(8)Digestive Endoscopy Unit, "S. Maria Goretti" Hospital, Latina, Italy;(9)Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery- University of Parma, Parma, Italy;(10)Division of Gastroenterology, "san Giovanni-Addolorata" Hospital, Rome, Italy;(11)Division of Gastroenterology, "Nuovo regina margherita" Territorial Hospital, Rome, Italy;(12)Department of Health Science, University of Catanzaro, Catanzaro, Italy;(13)Territorial Gastroenterology Service, Azienda Sanitaria Locale BA, Bari, Italy;(14)Division of Gastroenterology- IBD Unit, "S. Pertini"Hospital, Rome, Italy;(15)Division of Gastroenterology- IBD Unit, "A. Murri" Hospital, Fermo, Italy;(16)Division of Gastroenterology, "Ciaccio-Pugliese" Hospital, Catanzaro, Italy;(17)Division of Gastroenterology, "San Salvatore" Hospital, Pesaro, Italy;(18)Division of Gastroenterology, "Belcolle" Hospital, Viterbo, Italy;(19)Ambulatory of Territorial Gastroenterology, Sanitary Territorial Agency, Cosenza, Italy;(20)Division of Gastroenterology- IBD Unit, "S. Pertini" Hospital, Rome, Italy;(21)Ambulatory for IBD Treatment, "Valle D'Itria" Hospital, Martina Franca, Italy;(22)Division of Gastroenterology, "Annunziata Hospital", Cosenza, Italy;(23)Division of Gastroenterology, "San Camillo Forlanini" Hospital, Rome, Italy;(24)Division of Gastroenterology, "SS Annunziata" Hospital, Taranto, Italy;(25)Division of Gastroenterology, "San Salvatore" Hospital, Pesaro, Italy;(26)Division of Gastroenterology, "L. Sacco" University Hospital, Milan, Italy;(27)Division of General Surgery, "P. Colombo" Hospital- Roma 6, Rome, Italy;(28)Division of Gastroenterology, "S. Camillo Forlanini" Hospital, Rome, Italy;(29)Territorial Gastroenterology Service, Azienda Sanitaria Locale BAT, Andria, Italy


Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn’s Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics


194 CD patients (108 males and 86 females, mean age 48 years (range 38-58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients


At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up.
A logistic regression, UST therapy as thirdline therapy (after both anti-TNFα and vedolizumab), FC >200 μg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment


Ustekinumab seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.