121175 20240319081015.0 doi 10.1093/ibd/izab357 sideral 131827 ART-2022-131827 eng Chaparro, María Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN Study 2022 Access copy available to the general public Unrestricted Background 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. info:eu-repo/semantics/openAccess by-nc-nd http://creativecommons.org/licenses/by-nc-nd/3.0/es/ 4.9 2022 GASTROENTEROLOGY & HEPATOLOGY 28 / 93 = 0.301 2022 Q2 T1 1.834 2022 Immunology and Allergy 2022 Q1 Gastroenterology 2022 Q1 10.1 2022 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Baston-Rey, Iria Fernández-Salgado, Estela González García, Javier Ramos, Laura Diz-Lois Palomares, María Teresa Argüelles-Arias, Federico Iglesias Flores, Eva Cabello, Mercedes Rubio Iturria, Saioa Núñez Ortiz, Andrea Charro, Mara Ginard, Daniel Dueñas Sadornil, Carmen Merino Ochoa, Olga Busquets, David Iyo, Eduardo Gutiérrez Casbas, Ana Ramírez de la Piscina, Patricia Boscá-Watts, Marta Maia Arroyo, Maite García, María José Hinojosa, Esther Gordillo, Jordi Martínez Montiel, Pilar Velayos Jiménez, Benito Quílez Ivorra, Cristina Vázquez Morón, Juan María María Huguet, José González-Lama, Yago Muñagorri Santos, Ana Isabel Amo, Víctor Manuel Martín-Arranz, María Dolores Bermejo, Fernando Martínez Cadilla, Jesús Rubín de Célix, Cristina Fradejas Salazar, Paola San Román, Antonio López Jiménez, Nuria García López, Santiago Universidad de Zaragoza (orcid)0000-0003-3970-5457 Figuerola, Anna Jiménez, Itxaso Martínez Cerezo, Francisco José Taxonera, Carlos Varela, Pilar de Francisco, Ruth Monfort, David Molina Arriero, Gema Hernández Camba, Alejandro García-Alonso, Francisco Javier Van Domselaar, Manuel Pajares Villarroya, Ramón Núñez, Alejandro Rodríguez Moranta, Francisco Marín-Jiménez, Ignacio Robles Alonso, Virginia Martín Rodríguez, María del Mar Camo-Monterde, Patricia García Tercero, Iván Navarro Llavat, Mercedes Arias García, Lara Hervías Cruz, Daniel Sulleiro, Sara Novella, Cynthia Vispo, Eugenia Barreiro-de Acosta, Manuel Gisbert, Javier P 1007 610 Universidad de Zaragoza Dpto. Medicina, Psiqu. y Derm. Area Medicina 28, 11 (2022), 1725-1736 Inflamm. bowel dis. INFLAMMATORY BOWEL DISEASES 1078-0998 2526655 http://zaguan.unizar.es/record/121175/files/texto_completo.pdf Versión publicada 3072053 http://zaguan.unizar.es/record/121175/files/texto_completo.jpg?subformat=icon icon Versión publicada oai:zaguan.unizar.es:121175 articulos driver 2024-03-18-15:35:00 ARTICLE