Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.
Por:
Chaparro M, Garre A, Iborra M, Sierra M, Barreiro-de Acosta M, Fernández-Clotet A, de Castro L, Boscá-Watts M, Casanova MJ, López-García A, Lorente R, Rodríguez C, Carbajo AY, Arroyo MT, Gutiérrez A, Hinojosa J, Martínez-Pérez T, Villoria A, Bermejo F, Busquets D, Camps B, Cañete F, Manceñido N, Monfort D, Navarro-Llavat M, Pérez-Calle JL, Ramos L, Rivero M, Angueira T, Camo P, Carpio D, García-de-la-Filia I, González-Muñoza C, Hernández L, Huguet JM, Morales VJ, Sicilia B, Vega P, Vera I, Zabana Y, Nos P, Suárez Álvarez P, Calviño-Suarez C, Ricart E, Hernández V, Mínguez M, Márquez L, Hervías Cruz D, Rubio Iturria S, Barrio J, Gargayo-Puyuelo C, Francés R, Hinojosa E, Del Moral M, Calvet X, Algaba A, Aldeguer X, Guardiola J, Mañosa M, Pajares R, Piqueras M, García-Bosch O, Lopez Serrano P, Castro B, Lucendo AJ, Montoro M, Castro Ortiz E, Mesonero F, García-Planella E, Fuentes DA, Bort I, Delgado-Guillena P, Arias L, Iglesias A, Calvo M, Esteve M, Domènech E, Gisbert JP
Ahead of Print:
16 abr 2021
Resumen:
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.
Filiaciones:
Chaparro M:
Gastroenterology Departments 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 Departments 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:
Hospital Universitario y Politécnico La Fe and CIBERehd, Valencia, Spain
Sierra M:
Complejo Asistencial Universitario de León, León, Spain
Barreiro-de Acosta M:
Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
Fernández-Clotet A:
Hospital Clìnic i Provincial and CIBERehd, IDIBAPS, Barcelona, Spain
de Castro L:
Xerencia Xestion Integrada de Vigo, SERGAS. Vigo. Research Group in Digestive Diseases, Galicia Sur Health Research Institute (IIS Galicia Sur). SERGAS-UVIGO. Spain
Boscá-Watts M:
Hospital Clinico de Valencia. Universitat de València, Valencia, Spain
Casanova MJ:
Gastroenterology Departments 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:
Hospital del Mar and Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain
Lorente R:
Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
Rodríguez C:
Complejo Hospitalario de Navarra, Navarra, Spain
Carbajo AY:
Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León (SACYL). Valladolid, Spain
Arroyo MT:
HCU Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain
Gutiérrez A:
Hospital General Universitario de Alicante and CIBERehd, IIS ISABIAL Alicante, Spain
Hinojosa J:
Hospital de Manises, Valencia, Spain
Martínez-Pérez T:
Hospital Virgen de la Luz, Cuenca, Spain
Villoria A:
Hospital Parc Taulí, Sabadell. Depàrtament de Medicina. Universitat Autònoma de Barcelona and CIBERehd, Spain
Bermejo F:
Hospital Universitario Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz (IdiPAZ), Madrid, Spain
Busquets D:
Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain
Camps B:
Hospital Universitario de Bellvitge, Barcelona, Spain
Cañete F:
Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Spain
Manceñido N:
Hospital Infanta Sofía, San Sebastián de los Reyes, Spain
Monfort D:
Consorci Sanitari de Terrassa, Terrassa, Spain
Navarro-Llavat M:
Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain
Pérez-Calle JL:
Hospital Universitario Fundación Alcorcón, Madrid, Spain
Ramos L:
Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain
Rivero M:
Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain
Angueira T:
Hospital General de Tomelloso and CIBERehd, Ciudad Real, Spain
Camo P:
Hospital General San Jorge, Huesca, Spain
Carpio D:
Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain
García-de-la-Filia I:
Hospital Universitario Ramon y Cajal, Madrid, Spain
González-Muñoza C:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hernández L:
Hospital Santos Reyes, Burgos, Spain
Huguet JM:
Hospital General Universitario de Valencia, Valencia, Spain
Morales VJ:
Hospital General de Granollers, Barcelona, Spain
Sicilia B:
Hospital Universitario de Burgos, Burgos, Spain
Vega P:
Complejo Hospitalario Universitario de Ourense, Ourense, Spain
Vera I:
Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
Zabana Y:
Hospital Universitario Mútua Terrassa and CIBERehd, Terrassa, Spain
Nos P:
Hospital Universitario y Politécnico La Fe and CIBERehd, Valencia, Spain
Suárez Álvarez P:
Complejo Asistencial Universitario de León, León, Spain
Calviño-Suarez C:
Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
Ricart E:
Hospital Clìnic i Provincial and CIBERehd, IDIBAPS, Barcelona, Spain
Hernández V:
Xerencia Xestion Integrada de Vigo, SERGAS. Vigo. Research Group in Digestive Diseases, Galicia Sur Health Research Institute (IIS Galicia Sur). SERGAS-UVIGO. Spain
Mínguez M:
Hospital Clinico de Valencia. Universitat de València, Valencia, Spain
Márquez L:
Hospital del Mar and Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain
Hervías Cruz D:
Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
Rubio Iturria S:
Complejo Hospitalario de Navarra, Navarra, Spain
Barrio J:
Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León (SACYL). Valladolid, Spain
Gargayo-Puyuelo C:
HCU Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain
Francés R:
Hepatic and intestinal Immunobiology group Clinical Medicina, Department Miguel Hernández University, IIS ISABIAL, Hospital General Universitario de Alicante and CIBERehd, Alicante, Spain
Hinojosa E:
Hospital de Manises, Valencia, Spain
Del Moral M:
Hospital Virgen de la Luz, Cuenca, Spain
Calvet X:
Hospital Parc Taulí, Sabadell. Depàrtament de Medicina. Universitat Autònoma de Barcelona and CIBERehd, Spain
Algaba A:
Hospital Universitario Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz (IdiPAZ), Madrid, Spain
Aldeguer X:
Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain
Guardiola J:
Hospital Universitario de Bellvitge, Barcelona, Spain
Mañosa M:
Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Spain
Pajares R:
Hospital Infanta Sofía, San Sebastián de los Reyes, Spain
Piqueras M:
Consorci Sanitari de Terrassa, Terrassa, Spain
García-Bosch O:
Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain
Lopez Serrano P:
Hospital Universitario Fundación Alcorcón, Madrid, Spain
Castro B:
Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain
Lucendo AJ:
Hospital General de Tomelloso and CIBERehd, Ciudad Real, Spain
Montoro M:
Hospital General San Jorge, Huesca, Spain
Castro Ortiz E:
Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain
Mesonero F:
Hospital Universitario Ramon y Cajal, Madrid, Spain
García-Planella E:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Fuentes DA:
Hospital Santos Reyes, Burgos, Spain
Bort I:
Hospital General Universitario de Valencia, Valencia, Spain
Delgado-Guillena P:
Hospital General de Granollers, Barcelona, Spain
Arias L:
Hospital Universitario de Burgos, Burgos, Spain
Iglesias A:
Complejo Hospitalario Universitario de Ourense, Ourense, Spain
Calvo M:
Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
Esteve M:
Hospital Universitario Mútua Terrassa and CIBERehd, Terrassa, Spain
Domènech E:
Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Spain
Gisbert JP:
Gastroenterology Departments 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
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