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 C...

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Autores: Chaparro, M, Baston-Rey, I, Fernandez-Salgado, E, Garcia, JG, Ramos, L, Palomares, MTDL, Arguelles-Arias, F, Flores, EI, Cabello, M, Iturria, SR, Ortiz, AN, Charro, M, Ginard, D, Sadornil, CD, Ochoa, OM, Busquets, D, Iyo, E, Casbas, AG, de la Piscina, PR, Bosca-Watts, MM, Arroyo, M, Garcia, MJ, Hinojosa, E, Gordillo, J, Montiel, PM, Jimenez, BV, Ivorra, CQ, Moron, JMV, Huguet, JM, Gonzalez-Lama, Y, Santos, AIM, Amo, VM, Martin-Arranz, MD, Bermejo, F, Cadilla, JM, de Celix, CR, Salazar, PF, San Roman, AL, Jimenez, N, Lopez, SG, Figuerola, A, Jimenez, I, Cerezo, FJM, Taxonera, C, Varela, P, de Francisco, R, Monfort, D, Arriero, GM, Camba, AH, Garcia-Alonso, FJ, Van Domselaar, M, Villarroya, RP, Nunez, A, Moranta, FR, Marin-Jimenez, I, Alonso, VR, Rodriguez, MDM, Camo-Monterde, P, Tercero, IG, Llavat, MN, Garcia, LA, Cruz, DH, 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:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p13418
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/13418
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. Lay Summary This large retrospective study demonstrated the short- and long-term effectiveness and safety of ustekinumab in patients with Crohn's disease in real-world clinical practice, including those with refractory disease.

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