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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Detalhes bibliográficos
Autores: Chaparro, Maria, Baston-Rey, Iria, Fernandez-Salgado, Estela, Gonzalez Garcia, Javier, Ramos, Laura, Diz-Lois Palomares, Maria Teresa, Arguelles-Arias, Federico, Iglesias Flores, Eva, Cabello, Mercedes, Rubio Iturria, Saioa, Nunez Ortiz, Andrea, Charro, Mara, Ginard, Daniel, Duenas Sadornil, Carmen, Merino Ochoa, Olga, Busquets, David, Iyo, Eduardo, Gutierrez Casbas, Ana, Ramirez de la Piscina, Patricia, Bosca-Watts, Marta Maia, Arroyo, Maite, Garcia, Maria Jose, Hinojosa, Esther, Gordillo, Jordi, Martinez Montiel, Pilar, Velayos Jimenez, Benito, Quilez Ivorra, Cristina, Vazquez Moron, Juan Maria, Maria Huguet, Jose, Gonzalez-Lama, Yago, Munagorri Santos, Ana Isabel, Amo, Victor Manuel, Martin-Arranz, Maria Dolores, Bermejo, Fernando, Martinez Cadilla, Jesus, Rubin de Celix, Cristina, Fradejas Salazar, Paola, San Roman, Antonio Lopez, Jimenez, Nuria, Garcia Lopez, Santiago, Figuerola, Anna, Jimenez, Itxaso, Martinez Cerezo, Francisco Jose, Taxonera, Carlos, Varela, Pilar, de Francisco, Ruth, Monfort, David, Molina Arriero, Gema, Hernandez Camba, Alejandro, Garcia-Alonso, Francisco Javier, Van Domselaar, Manuel, Pajares Villarroya, Ramon, Nunez, Alejandro, Rodriguez Moranta, Francisco, Marin-Jimenez, Ignacio, Robles Alonso, Virginia, Martin Rodriguez, Maria Del Mar, Camo-Monterde, Patricia, Garcia Tercero, Ivan, Navarro Llavat, Mercedes, Arias Garcia, Lara, Hervias Cruz, Daniel, Sulleiro, Sara, Novella, Cynthia, Vispo, Eugenia, Barreiro-de Acosta, Manuel, Gisbert, Javier P
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2022
País:España
Recursos:INCLIVA
Repositório:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p16427
Acesso em linha:https://incliva.portalinvestigacion.com/publicaciones/16427
Access Level:Acceso aberto
Palavra-chave:Crohn’s disease
effectiveness
real-world evidence
safety
ustekinumab
Descrição
Resumo: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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