P505 Real word long-term efficacy and safety of vedolizumab in managing ulcerative colitis versus crohn’s disease: results from “long vedo” italian multicenter study
MocciMD FRCP, G.(1)*;Maconi , G.(2);Onidi, F.M.(1);Cataletti, G.(2);Elisei , W.(3);Scaldaferri, F.(4);Lorenzetti , R.(5);Pagnini, C.(6);Scarcelli, A.(7);Graziani , M.G.(6);Di Paolo , M.C.(8);Pranzo, G.(9);Luppino, I.(9);Monterubbianesi, R.(10);Faggiani, R.(3);Ferronato, A.(11);Savarino, E.(12);Pica, R.(13);Cocco, A.(13);Rodino, S.(14); Sebkova, L.(15);Zampaletta, C.(16);Gaiani, F.(17);Fanigliulo, L.(18);Allegretta , L.(19);Cuomo, A.(20);Donnarumma, L.(21);Della Valle , N.(22);Forti, G.(23);Antonelli, E.(24);Bassotti , G.(24);Iannelli, C.(25);Aragona, G.(26);Lauria, A.(27);Piergallini, S.(28);Colucci, R.(29);Binaghi, L.(1);Meucci, C.(30);Papa, A.(4);Tursi, A.(31);
(1)Arnas- Brotzu Hospital- Gastroenterology Unit, Department of Internal Medicine, Cagliari, Italy;(2)Division of Gastroenterology- “L. Sacco” University Hospital, Division of Gastroenterology- “L. Sacco” University Hospital, Milan, Italy;(3)A.O. “S. Camillo-Folanini”, Division of Gastroenterology- A.O. “S. Camillo-Forlanini”, Rome, Italy;(4)Division of Internal Medicine and Gastroenterology- Policlinico Universitario “A. Gemelli” IRCCS Foundation, Department of Medical and Surgical Sciences, Rome, Italy;(5)“Nuovo Regina Margherita” Territorial Hospital, 17 Division of Gastroenterology-, Rome, Italy;(6)Division of Gastroenterology- “S. Giovanni - Addolorata” Hospital, Division of Gastroenterology- “S. Giovanni - Addolorata” Hospital, Rome, Italy;(7)3 Division of Gastroenterology- “San Salvatore” Hospital-, 3 Division of Gastroenterology- “San Salvatore” Hospital-, Pesaro, Italy;(8)Division of Gastroenterology- “S. Giovanni - Addolorata” Hospital-, Division of Gastroenterology- “S. Giovanni - Addolorata” Hospital-, Rome, Italy;(9)Division of Gastroenterology- “Annunziata” Hospital-, Division of Gastroenterology- “Annunziata” Hospital-, Cosenza, Italy;(10)A.O. “S. Camillo-Forlanini”, Division of Gastroenterology- A.O. “S. Camillo-Forlanini”, Rome, Italy;(11)Digestive Endoscopy Unit- ULSS7 Pedemontana-, Digestive Endoscopy Unit- ULSS7 Pedemontana-, Santorso, Italy;(12)Gastroenterology Unit- Azienda Ospedale-Università di Padova AOUP-, Gastroenterology Unit- Azienda Ospedale-Università di Padova AOUP-, Padua, Italy;(13)Division of Gastroenterology- IBD Unit- “S. Pertini” Hospital, Division of Gastroenterology- IBD Unit- “S. Pertini” Hospital, Rome, Italy;(14)Division of Gastroenterology- “Ciaccio-Pugliese” Hospital- Catanzaro- Italy, Division of Gastroenterology- “Ciaccio-Pugliese” Hospital- Catanzaro- Italy, Catanzaro, Italy;(15)Division of Gastroenterology- “Belcolle” Hospital-, Division of Gastroenterology- “Belcolle” Hospital-, Viterbo, Italy;(16)Gastroenterology and Endoscopy Unit- Department of Medicine and Surgery- University of Parma-, Gastroenterology and Endoscopy Unit- Department of Medicine and Surgery- University of Parma, Parma, Italy;(17)Gastroenterology and Endoscopy Unit- Department of Medicine and Surgery- University of Parma-, Gastroenterology and Endoscopy Unit- Department of Medicine and Surgery- University of Parma-, Parma, Italy;(18)Division of Gastroenterology- “S.S. Annunziata” Hospital-, Division of Gastroenterology- “S.S. Annunziata” Hospital-, Taranto, Italy;(19)Division of Gastroenterology- “Santa Caterina Novella” Hospital-, Division of Gastroenterology- “Santa Caterina Novella” Hospital-, Galatina, Italy;(20)Division of Gastroenterology- “Umberto I” Hospital- Nocera Inferiore, Division of Gastroenterology- “Umberto I” Hospital- Nocera Inferiore, Nocera Inferiore SA, Italy;(21)Division of Gastroenterology- “Umberto I” Hospital-, Division of Gastroenterology- “Umberto I” Hospital-, Nocera Inferiore SA, Italy;(22)Division of Gastroenterology- A.O. “Ospedali Riuniti”-, Division of Gastroenterology- A.O. “Ospedali Riuniti”-, Foggia, Italy;(23)Division of Digestive Endoscopy- “S. Maria Goretti” Hospital-, Division of Digestive Endoscopy- “S. Maria Goretti” Hospital-, Latina, Italy;(24)Gastroenterology & Hepatology Section- Department of Medicine & Surgery- University of Perugia-, Gastroenterology & Hepatology Section- Department of Medicine & Surgery- University of Perugia-, Perugia, Italy;(25)Department of Health Science- University of Catanzaro-, Department of Health Science- University of Catanzaro-, Catanzaro, Italy;(26)Division of Gastroenterology- “Guglielmo da Saliceto" Hospital-, Division of Gastroenterology- “Guglielmo da Saliceto" Hospital-, Piacenza, Italy;(27)Division of Gastroenterology- A.O. “Bianchi-Melacrino-Morelli”-, Division of Gastroenterology- A.O. “Bianchi-Melacrino-Morelli”-, Reggio Calabria, Italy;(28)Division of Gastroenterology- IBD Unit- “A. Murri” Hospital-, Division of Gastroenterology- IBD Unit- “A. Murri” Hospital-, Fermo, Italy;(29)Digestive Endoscopy Unit- “San Matteo degli Infermi” Hospital- Spoleto PG- Italy, Digestive Endoscopy Unit- “San Matteo degli Infermi” Hospital- Spoleto PG- Italy, Spoleto, Italy;(30)Division of Gastroenterology- “T. Maresca” Hospital-, Division of Gastroenterology- “T. Maresca” Hospital-, Torre del Greco Na, Italy;(31)Territorial Gastroenterology Service- ASL BAT, Territorial Gastroenterology Service- ASL BAT, Andria, Italy;
Background
Current data about long-term use of vedolizumab (VDZ) in ulcerative colitis (UC) versus Crohn’s disease (CD) patients are limited. We aimed to assess whether there are differences in term of long-term efficacy and safety of VDZ in UC vs. CD patients.
Methods
Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission within 6 month of treatment, maintenance of clinical remission during a long follow-up, and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), steroid discontinuation, and treatment optimization during the follow-up.
Results
The study group consisted of 729 patients (475 patients with UC and 254 CD patients with CD) with a median follow-up of 18 (interquartile range 6-36) months. Clinical remission at the 6th month of treatment was achieved in 488 (66.9%) patients, higher in CD patients (74.4 vs. 62.9, p<0.000) while, at the maximal follow-up, it was achieved and maintained in 81.5% of patients (UC vs. CD, p=0.667). At uni- and multivariate analysis, reaching clinical remission at the 6th month of treatment (p=0.001) and being naïve to biologics were significantly associated with longer clinical remission (p<0.0001). Long-term follow up clinical response was significantly higher in UC vs. CD (p=0.023) and surgery occurred more frequently in CD (p=0.04), while no difference were found between UC and CD about the other secondary endpoints
Conclusion
Overall, no significant differences were found about the long-term use of VDZ in UC vs. CD. However, we identified some parameters the can help the physician to predict the long-term efficacy of this drug.