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2021-04-01

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cc-by-nc-nd (c) European Crohn's and Colitis Organisation (ECCO), 2021
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/181737

Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry

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https://doi.org/10.1093/ecco-jcc/jjab070

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Abstract Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims: To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life. Methods: Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at week 16. Results: A total of 95 patients were included. At week 16, 53% of patients had response (including 35% of patients in remission). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at weeks 24 and 52, respectively. Thirty-six percent of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusions: Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab

Matèries

Colitis ulcerosa, Anticossos monoclonals

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Ulcerative colitis, Monoclonal antibodies

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Col·leccions

Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

CHAPARRO, María, GARRE, Ana, IBORRA, Marisa, SIERRA AUSÍN, Mónica, BARREIRO DE ACOSTA, Manuel, FERNÁNDEZ CLOTET, Agnès, CASTRO, Luisa de, BOSCÁ WATTS, Maia, CASANOVA, María josé, LÓPEZ GARCÍA, Alicia, LORENTE, Rufo, RODRÍGUEZ, Cristina, CARBAJO, Ana y., ARROYO, María teresa, GUTIÉRREZ, Ana, HINOJOSA, Joaquín, MARTÍNEZ PÉREZ, Teresa, VILLORIA, Albert, BERMEJO, Fernando, BUSQUETS, David, CAMPS, Blau, CAÑETE, Fiorella, MANCEÑIDO, Noemí, MONFORT, David, NAVARRO LLAVAT, Mercè, PÉREZ CALLE, José lázaro, RAMOS, Laura, RIVERO, Montserrat, ANGUEIRA, Teresa, CAMO MONTERDE, Patricia, CARPIO, Daniel, GARCÍA DE LA FILIA, Irene, GONZÁLEZ MUÑOZA, Carlos, HERNÁNDEZ, Luís, HUGUET, José m., MORALES, Víctor j., SICILIA, Beatriz, VEGA, Pablo, VERA, Isabel, ZABANA, Yamile. Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. _Journal of Crohn's and Colitis_. 2021. Vol. 15, núm. 11, pàgs. 1846-1851. [consulta: 23 de gener de 2026]. ISSN: 1873-9946. [Disponible a: https://hdl.handle.net/2445/181737]

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