Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry.

Autor: Chaparro M; Gastroenterology Department of Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP], Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Madrid. Spain., Garre A; Gastroenterology Department of Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP], Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Madrid. Spain., Iborra M; Gastroenterology Department of Hospital Universitario y Politécnico La Fe and CIBERehd, Valencia, Spain., Sierra-Ausín M; Gastroenterology Department of Hospital Universitario de León, Gerencia regional de salud de Castilla y León, León, Spain., Barreiro-de Acosta M; Gastroenterology Department of Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain., Fernández-Clotet A; Gastroenterology Department of Hospital Clìnic i Provincial and CIBERehd, IDIBAPS, Barcelona, Spain., de Castro L; Gastroenterology Department of Xerencia Xestion Integrada de Vigo, Research Group in Digestive Diseases, Galicia Sur Health Research Institute, SERGAS-UVIGO, Spain., Boscá-Watts M; Gastroenterology Department of Hospital Clinico de Valencia. Universitat de València, Valencia, Spain., Casanova MJ; Gastroenterology Department of Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP], Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Madrid. Spain., López-García A; Gastroenterology Department of Hospital del Mar and Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain., Lorente R; Gastroenterology Department of Hospital Clínico Universitario Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain., Rodríguez C; Gastroenterology Department of Complejo Hospitalario de Navarra, Navarra, Spain., Carbajo AY; Gastroenterology Department of Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León [SACYL], Valladolid, Spain., Arroyo MT; Gastroenterology Department of HCU Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain., Gutiérrez A; Gastroenterology Department of Hospital General Universitario de Alicante and CIBERehd, IIS ISABIAL Alicante, Spain., Hinojosa J; Gastroenterology Department of Hospital de Manises, Valencia, Spain., Martínez-Pérez T; Gastroenterology Department of Hospital Virgen de la Luz, Cuenca, Spain., Villoria A; Gastroenterology Department of Hospital Parc Taulí, Sabadell, Departament de Medicina, Universitat Autònoma de Barcelona and CIBERehd, Spain., Bermejo F; Gastroenterology Department of Hospital Universitario Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz [IdiPAZ], Madrid, Spain., Busquets D; Gastroenterology Department of Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain., Camps B; Gastroenterology Department of Hospital Universitario de Bellvitge, Barcelona, Spain., Cañete F; Gastroenterology Department of Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Spain., Manceñido N; Gastroenterology Department of Hospital Infanta Sofía, San Sebastián de los Reyes, Spain., Monfort D; Gastroenterology Department of Consorci Sanitari de Terrassa, Terrassa, Spain., Navarro-Llavat M; Gastroenterology Department of Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain., Pérez-Calle JL; Gastroenterology Department of Hospital Universitario Fundación Alcorcón, Madrid, Spain., Ramos L; Gastroenterology Department of Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain., Rivero M; Gastroenterology Department of Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain., Angueira T; Gastroenterology Department of Hospital General de Tomelloso and CIBERehd, Ciudad Real, Spain., Camo Monterde P; Gastroenterology Department of Hospital General San Jorge, Huesca, Spain., Carpio D; Gastroenterology Department of Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain., García-de-la-Filia I; Gastroenterology Department of Hospital Universitario Ramon y Cajal, Madrid, Spain., González-Muñoza C; Gastroenterology Department of Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Hernández L; Gastroenterology Department of Hospital Santos Reyes, Burgos, Spain., Huguet JM; Gastroenterology Department of Hospital General Universitario de Valencia, Valencia, Spain., Morales VJ; Gastroenterology Department of Hospital General de Granollers, Barcelona, Spain., Sicilia B; Gastroenterology Department of Hospital Universitario de Burgos, Burgos, Spain., Vega P; Gastroenterology Department of Complejo Hospitalario Universitario de Ourense, Ourense, Spain., Vera I; Gastroenterology Department of Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., Zabana Y; Gastroenterology Department of Hospital Universitari Mútua Terrassa and CIBERehd, Terrassa, Spain., Nos P; Gastroenterology Department of Hospital Universitario y Politécnico La Fe and CIBERehd, Valencia, Spain., Suárez Álvarez P; Gastroenterology Department of Hospital Universitario de León, Gerencia regional de salud de Castilla y León, León, Spain., Calviño-Suárez C; Gastroenterology Department of Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain., Ricart E; Gastroenterology Department of Hospital Clìnic i Provincial and CIBERehd, IDIBAPS, Barcelona, Spain., Hernández V; Gastroenterology Department of Xerencia Xestion Integrada de Vigo, Research Group in Digestive Diseases, Galicia Sur Health Research Institute, SERGAS-UVIGO, Spain., Mínguez M; Gastroenterology Department of Hospital Clinico de Valencia. Universitat de València, Valencia, Spain., Márquez L; Gastroenterology Department of Hospital del Mar and Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain., Hervías Cruz D; Gastroenterology Department of Hospital Clínico Universitario Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain., Rubio Iturria S; Gastroenterology Department of Complejo Hospitalario de Navarra, Navarra, Spain., Barrio J; Gastroenterology Department of Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León [SACYL], Valladolid, Spain., Gargallo-Puyuelo C; Gastroenterology Department of HCU Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain., Francés R; Gastroenterology Department of Hepatic and Intestinal Immunobiology Group, Department of Clinical Medicine, Miguel Hernández University, IIS Isabial-Hospital General Universitario de Alicante and CIBERehd, Alicante, Spain., Hinojosa E; Gastroenterology Department of Hospital de Manises, Valencia, Spain., Del Moral M; Gastroenterology Department of Hospital Virgen de la Luz, Cuenca, Spain., Calvet X; Gastroenterology Department of Hospital Parc Taulí, Sabadell, Departament de Medicina, Universitat Autònoma de Barcelona and CIBERehd, Spain., Algaba A; Gastroenterology Department of Hospital Universitario Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz [IdiPAZ], Madrid, Spain., Aldeguer X; Gastroenterology Department of Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain., Guardiola J; Gastroenterology Department of Hospital Universitario de Bellvitge, Barcelona, Spain., Mañosa M; Gastroenterology Department of Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Spain., Pajares R; Gastroenterology Department of Hospital Infanta Sofía, San Sebastián de los Reyes, Spain., Piqueras M; Gastroenterology Department of Consorci Sanitari de Terrassa, Terrassa, Spain., García-Bosch O; Gastroenterology Department of Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain., López Serrano P; Gastroenterology Department of Hospital Universitario Fundación Alcorcón, Madrid, Spain., Castro B; Gastroenterology Department of Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain., Lucendo AJ; Gastroenterology Department of Hospital General de Tomelloso and CIBERehd, Ciudad Real, Spain., Montoro M; Gastroenterology Department of Hospital General San Jorge, Huesca, Spain., Castro Ortiz E; Gastroenterology Department of Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain., Mesonero F; Gastroenterology Department of Hospital Universitario Ramon y Cajal, Madrid, Spain., García-Planella E; Gastroenterology Department of Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Fuentes DA; Gastroenterology Department of Hospital Santos Reyes, Burgos, Spain., Bort I; Gastroenterology Department of Hospital General Universitario de Valencia, Valencia, Spain., Delgado-Guillena P; Gastroenterology Department of Hospital General de Granollers, Barcelona, Spain., Arias L; Gastroenterology Department of Hospital Universitario de Burgos, Burgos, Spain., Iglesias A; Gastroenterology Department of Complejo Hospitalario Universitario de Ourense, Ourense, Spain., Calvo M; Gastroenterology Department of Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., Esteve M; Gastroenterology Department of Hospital Universitari Mútua Terrassa and CIBERehd, Terrassa, Spain., Domènech E; Gastroenterology Department of Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Spain., Gisbert JP; Gastroenterology Department of Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP], Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Madrid. Spain.
Jazyk: angličtina
Zdroj: Journal of Crohn's & colitis [J Crohns Colitis] 2021 Nov 08; Vol. 15 (11), pp. 1846-1851.
DOI: 10.1093/ecco-jcc/jjab070
Abstrakt: Background and Aims: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed 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; 36% 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 in both 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.
(© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze: MEDLINE
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