doi:10.1093/ibd/izab357engChaparro, MaríaBaston-Rey, IriaFernández-Salgado, EstelaGonzález García, JavierRamos, LauraDiz-Lois Palomares, María TeresaArgüelles-Arias, FedericoIglesias Flores, EvaCabello, MercedesRubio Iturria, SaioaNúñez Ortiz, AndreaCharro, MaraGinard, DanielDueñas Sadornil, CarmenMerino Ochoa, OlgaBusquets, DavidIyo, EduardoGutiérrez Casbas, AnaRamírez de la Piscina, PatriciaBoscá-Watts, Marta MaiaArroyo, MaiteGarcía, María JoséHinojosa, EstherGordillo, JordiMartínez Montiel, PilarVelayos Jiménez, BenitoQuílez Ivorra, CristinaVázquez Morón, Juan MaríaMaría Huguet, JoséGonzález-Lama, YagoMuñagorri Santos, Ana IsabelAmo, Víctor ManuelMartín-Arranz, María DoloresBermejo, FernandoMartínez Cadilla, JesúsRubín de Célix, CristinaFradejas Salazar, PaolaSan Román, Antonio LópezJiménez, NuriaGarcía López, SantiagoFiguerola, AnnaJiménez, ItxasoMartínez Cerezo, Francisco JoséTaxonera, CarlosVarela, Pilarde Francisco, RuthMonfort, DavidMolina Arriero, GemaHernández Camba, AlejandroGarcía-Alonso, Francisco JavierVan Domselaar, ManuelPajares Villarroya, RamónNúñez, AlejandroRodríguez Moranta, FranciscoMarín-Jiménez, IgnacioRobles Alonso, VirginiaMartín Rodríguez, María del MarCamo-Monterde, PatriciaGarcía Tercero, IvánNavarro Llavat, MercedesArias García, LaraHervías Cruz, DanielSulleiro, SaraNovella, CynthiaVispo, EugeniaBarreiro-de Acosta, ManuelGisbert, Javier PLong-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN StudyART-2022-131827Background Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn’s disease (CD) patients in real-world clinical practice. Methods A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. Results A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). Conclusions Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.2022http://zaguan.unizar.es/record/12117510.1093/ibd/izab357http://zaguan.unizar.es/record/121175oai:zaguan.unizar.es:121175INFLAMMATORY BOWEL DISEASES 28, 11 (2022), 1725-1736by-nc-ndhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccess