Chaparro, MariaBaston-Rey, IriaFernandez-Salgado, EstelaGonzalez-Garcia, JavierRamos, LauraDiz-Lois Palomares, Maria TeresaArguelles-Arias, FedericoIglesias-Flores, EvaCabello, MercedesRubio-Iturria, SaioaNuñez-Ortiz, AndreaCharro, MaraGinard, DanielDueñas-Sadornil, CarmenMerino-Ochoa, OlgaBusquets, DavidIyo, EduardoGutierrez-Casbas, AnaRamirez-de-la-Piscina, PatriciaBosca-Watts, Marta MaiaArroyo, MaiteGarcia, Maria JoseHinojosa, EstherGordillo, JordiMartinez-Montiel, PilarVelayos-Jimenez, BenitoQuilez-Ivorra, CristinaVazquez-Moron, Juan MariaMaria-Huguet, JoseGonzalez-Lama, YagoMuñagorri-Santos, Ana IsabelAmo, Victor ManuelMartin-Arranz, Maria DoloresBermejo, FernandoMartinez-Cadilla, JesusRubin-de-Celix, CristinaFradejas-Salazar, PaolaLopez-San-Roman, AntonioJimenez, NuriaGarcia-Lopez, SantiagoFiguerola, AnnaJimenez, ItxasoMartinez-Cerezo, Francisco JoseTaxonera, CarlosVarela, Pilarde-Francisco, RuthMonfort, DavidMolina-Arriero, GemaHernandez-Camba, AlejandroGarcia-Alonso, Francisco JavierVan-Domselaar, ManuelPajares-Villarroya, RamonNuñez, AlejandroRodriguez-Moranta, FranciscoMarin-Jimenez, IgnacioRobles-Alonso, VirginiaMartin-Rodriguez, Maria Del MarCamo-Monterde, PatriciaGarcia-Tercero, IvanNavarro-Llavat, MercedesArias-Garcia, LaraHervias-Cruz, DanielSulleiro, SaraNovella, CynthiaVispo, EugeniaBarreiro-de-Acosta, ManuelGisbert, Javier P2023-05-032023-05-032022-02-15Chaparro M, Baston-Rey I, Fernández-Salgado E, González García J, Ramos L, Diz-Lois Palomares MT, et al. Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study. Inflamm Bowel Dis. 2022 Nov 2;28(11):1725-1736http://hdl.handle.net/10668/19795Large 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. 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. 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). Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/Crohn’s diseaseEffectivenessReal-world evidenceSafetyUstekinumabÁrea de Gestión Sanitaria Norte de AlmeríaÁrea de Gestión Sanitaria Sur de SevillaÁrea de Gestión Sanitaria Norte de AlmeríaÁrea de Gestión Sanitaria Sur de SevillaÁrea de Gestión Sanitaria Sur de SevillaHumansUstekinumabCrohn diseaseRetrospective studiesRemission inductionImmunosuppressive agentsTreatment outcomeresearch article35166347open accessEnfermedad de CrohnEstudios retrospectivosInducción de remisiónInmunosupresoresResultado del tratamiento10.1093/ibd/izab3571536-4844PMC9629456https://academic.oup.com/ibdjournal/advance-article-pdf/doi/10.1093/ibd/izab357/42535184/izab357.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9629456/pdf