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

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...

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Autores: Chaparro M, Baston-Rey I, Fernández-Salgado E, González García J, Ramos L, Diz-Lois Palomares MT, Argüelles-Arias F, Iglesias Flores E, Cabello M, Rubio Iturria S, Núñez Ortiz A, Charro M, Ginard D, Dueñas Sadornil C, Merino Ochoa O, Busquets D, Iyo E, Gutiérrez Casbas A, Ramírez de la Piscina P, Boscá-Watts MM, Arroyo M, García MJ, Hinojosa E, Gordillo J, Martínez Montiel P, Velayos Jiménez B, Quílez Ivorra C, Vázquez Morón JM, María Huguet J, González-Lama Y, Muñagorri Santos AI, Amo VM, Martín-Arranz MD, Bermejo F, Martínez Cadilla J, Rubín de Célix C, Fradejas Salazar P, San Román AL, Jiménez N, García López S, Figuerola A, Jiménez I, Martínez Cerezo FJ, Taxonera C, Varela P, de Francisco R, Monfort D, Molina Arriero G, Hernández Camba A, García-Alonso FJ, Van Domselaar M, Pajares Villarroya R, Núñez A, Rodríguez Moranta F, Marín-Jiménez I, Robles Alonso V, Martín Rodríguez MDM, Camo-Monterde P, García Tercero I, Navarro Llavat M, Arias García L, Hervías Cruz D, Sulleiro S, Novella C, Vispo E, Barreiro-de Acosta M, Gisbert JP
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p8259
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones8259
Access Level:acceso abierto
Palabra clave:Crohn’s disease
effectiveness
real-world evidence
safety
ustekinumab
Descripción
Sumario: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.

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