Portal de Periódicos da CAPES

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN Study

2022; Oxford University Press; Volume: 28; Issue: 11 Linguagem: Inglês

10.1093/ibd/izab357

1536-4844

María Chaparro, Iria Bastón‐Rey, E Fernández-Salgado, Javier González García, Laura Ramos, M T Diz-Lois Palomares, Federico Argüelles‐Arias, Eva Iglesias Flores, Mercedes Cabello, Saioa Rubio Iturria, Andrea Núñez Ortiz, Mara Charro, Daniel Ginard, Carmen Dueñas Sadornil, Olga Merino Ochoa, David Busquets, Eduardo Iyo, Ana Gutiérrez, Patricia Ramírez de la Piscina, Marta Maia Boscá-Watts, M Arroyo, María José García, Esther Hinojosa, Jordi Gordillo, P Martínez Montiel, Benito Velayos Jiménez, Cristina Quílez Ivorra, Juan María Vázquez Morón, José María Huguet, Yago González‐Lama, Ana Isabel Muñagorri Santos, V Amo, María Dolores Martín‐Arranz, Fernando Bermejo, J Martínez Cadilla, Cristina Rubín de Célix, Paola Fradejas Salazar, Antonio Román, Nuria Jiménez, Santiago García‐López, Anna Figuerola, I Jiménez, Francisco J. Martínez-Cerezo, Carlos Taxonera, Pilar Varela, Ruth de Francisco, David Monfort, G Molina Arriero, Alejandro Hernández-Camba, Francisco Javier García-Alonso, Manuel Van Domselaar, Ramón Pajares Villarroya, Alejandro Mena Nunez, Francisco Rodríguez‐Moranta, Ignacio Marín‐Jiménez, Virginia Robles, María del Mar Martín Rodríguez, Patricia Camo-Monterde, Iván García Tercero, Mercedes Navarro Llavat, Lara Arias García, Daniel Hervías Cruz, Sara Sulleiro, Cynthia Novella, Eugenia Vispo, Manuel Barreiro‐de Acosta, Javier P. Gisbert,

Diagnosis and treatment of tuberculosis

Abstract 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.