Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.
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 p...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2021 |
| País: | España |
| Recursos: | INCLIVA |
| Repositorio: | r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
| OAI Identifier: | oai:incliva.fundanetsuite.com:p15678 |
| Acesso em linha: | https://incliva.portalinvestigacion.com/publicaciones/15678 |
| Access Level: | acceso abierto |
| Palavra-chave: | Ustekinumab ulcerative colitis response remission durability real-world evidence |
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oai:incliva.fundanetsuite.com:p15678 |
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| network_name_str |
España |
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Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.Chaparro, MariaGarre, AnaIborra, MarisaSierra, MonicaBarreiro-de Acosta, ManuelFernandez-Clotet, Agnesde Castro, LuisaBosca-Watts, MaiaCasanova, Maria JoseLopez-Garcia, AliciaLorente, RufoRodriguez, CristinaCarbajo, Ana YArroyo, Maria TeresaGutierrez, AnaHinojosa, JoaquinMartinez-Perez, TeresaVilloria, AlbertBermejo, FernandoBusquets, DavidCamps, BlauCanete, FiorellaMancenido, NoemiMonfort, DavidNavarro-Llavat, MercePerez-Calle, Jose LazaroRamos, LauraRivero, MontserratAngueira, TeresaCamo, PatriciaCarpio, DanielGarcia-de-la-Filia, IreneGonzalez-Munoza, CarlosHernandez, LuisHuguet, Jose MMorales, Victor JSicilia, BeatrizVega, PabloVera, IsabelZabana, YamileNos, PilarSuarez Alvarez, PatriciaCalvino-Suarez, CristinaRicart, ElenaHernandez, VicentMinguez, MiguelMarquez, LuciaHervias Cruz, DanielRubio Iturria, SaioaBarrio, JesusGargayo-Puyuelo, CarlaFrances, RubenHinojosa, EstherDel Moral, MariaCalvet, XavierAlgaba, AliciaAldeguer, XavierGuardiola, JordiManosa, MiriamPajares, RamonPiqueras, MartaGarcia-Bosch, OrlandoLopez Serrano, PilarCastro, BeatrizLucendo, Alfredo JMontoro, MiguelCastro Ortiz, ElenaMesonero, FranciscoGarcia-Planella, EstherFuentes, David ABort, InmaculadaDelgado-Guillena, PedroArias, LaraIglesias, AguedaCalvo, MartaEsteve, MariaDomenech, EugeniGisbert, Javier PUstekinumabulcerative colitisresponseremissiondurabilityreal-world evidenceBACKGROUND: 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.OXFORD UNIV PRESS2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/15678Journal of Crohns & ColitisISSN: 18739946ISSNe: 18764479reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p156782026-06-07T16:35:31Z |
| dc.title.none.fl_str_mv |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| title |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| spellingShingle |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. Chaparro, Maria Ustekinumab ulcerative colitis response remission durability real-world evidence |
| title_short |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| title_full |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| title_fullStr |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| title_full_unstemmed |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| title_sort |
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. |
| dc.creator.none.fl_str_mv |
Chaparro, Maria Garre, Ana Iborra, Marisa Sierra, Monica Barreiro-de Acosta, Manuel Fernandez-Clotet, Agnes de Castro, Luisa Bosca-Watts, Maia Casanova, Maria Jose Lopez-Garcia, Alicia Lorente, Rufo Rodriguez, Cristina Carbajo, Ana Y Arroyo, Maria Teresa Gutierrez, Ana Hinojosa, Joaquin Martinez-Perez, Teresa Villoria, Albert Bermejo, Fernando Busquets, David Camps, Blau Canete, Fiorella Mancenido, Noemi Monfort, David Navarro-Llavat, Merce Perez-Calle, Jose Lazaro Ramos, Laura Rivero, Montserrat Angueira, Teresa Camo, Patricia Carpio, Daniel Garcia-de-la-Filia, Irene Gonzalez-Munoza, Carlos Hernandez, Luis Huguet, Jose M Morales, Victor J Sicilia, Beatriz Vega, Pablo Vera, Isabel Zabana, Yamile Nos, Pilar Suarez Alvarez, Patricia Calvino-Suarez, Cristina Ricart, Elena Hernandez, Vicent Minguez, Miguel Marquez, Lucia Hervias Cruz, Daniel Rubio Iturria, Saioa Barrio, Jesus Gargayo-Puyuelo, Carla Frances, Ruben Hinojosa, Esther Del Moral, Maria Calvet, Xavier Algaba, Alicia Aldeguer, Xavier Guardiola, Jordi Manosa, Miriam Pajares, Ramon Piqueras, Marta Garcia-Bosch, Orlando Lopez Serrano, Pilar Castro, Beatriz Lucendo, Alfredo J Montoro, Miguel Castro Ortiz, Elena Mesonero, Francisco Garcia-Planella, Esther Fuentes, David A Bort, Inmaculada Delgado-Guillena, Pedro Arias, Lara Iglesias, Agueda Calvo, Marta Esteve, Maria Domenech, Eugeni Gisbert, Javier P |
| author |
Chaparro, Maria |
| author_facet |
Chaparro, Maria Garre, Ana Iborra, Marisa Sierra, Monica Barreiro-de Acosta, Manuel Fernandez-Clotet, Agnes de Castro, Luisa Bosca-Watts, Maia Casanova, Maria Jose Lopez-Garcia, Alicia Lorente, Rufo Rodriguez, Cristina Carbajo, Ana Y Arroyo, Maria Teresa Gutierrez, Ana Hinojosa, Joaquin Martinez-Perez, Teresa Villoria, Albert Bermejo, Fernando Busquets, David Camps, Blau Canete, Fiorella Mancenido, Noemi Monfort, David Navarro-Llavat, Merce Perez-Calle, Jose Lazaro Ramos, Laura Rivero, Montserrat Angueira, Teresa Camo, Patricia Carpio, Daniel Garcia-de-la-Filia, Irene Gonzalez-Munoza, Carlos Hernandez, Luis Huguet, Jose M Morales, Victor J Sicilia, Beatriz Vega, Pablo Vera, Isabel Zabana, Yamile Nos, Pilar Suarez Alvarez, Patricia Calvino-Suarez, Cristina Ricart, Elena Hernandez, Vicent Minguez, Miguel Marquez, Lucia Hervias Cruz, Daniel Rubio Iturria, Saioa Barrio, Jesus Gargayo-Puyuelo, Carla Frances, Ruben Hinojosa, Esther Del Moral, Maria Calvet, Xavier Algaba, Alicia Aldeguer, Xavier Guardiola, Jordi Manosa, Miriam Pajares, Ramon Piqueras, Marta Garcia-Bosch, Orlando Lopez Serrano, Pilar Castro, Beatriz Lucendo, Alfredo J Montoro, Miguel Castro Ortiz, Elena Mesonero, Francisco Garcia-Planella, Esther Fuentes, David A Bort, Inmaculada Delgado-Guillena, Pedro Arias, Lara Iglesias, Agueda Calvo, Marta Esteve, Maria Domenech, Eugeni Gisbert, Javier P |
| author_role |
author |
| author2 |
Garre, Ana Iborra, Marisa Sierra, Monica Barreiro-de Acosta, Manuel Fernandez-Clotet, Agnes de Castro, Luisa Bosca-Watts, Maia Casanova, Maria Jose Lopez-Garcia, Alicia Lorente, Rufo Rodriguez, Cristina Carbajo, Ana Y Arroyo, Maria Teresa Gutierrez, Ana Hinojosa, Joaquin Martinez-Perez, Teresa Villoria, Albert Bermejo, Fernando Busquets, David Camps, Blau Canete, Fiorella Mancenido, Noemi Monfort, David Navarro-Llavat, Merce Perez-Calle, Jose Lazaro Ramos, Laura Rivero, Montserrat Angueira, Teresa Camo, Patricia Carpio, Daniel Garcia-de-la-Filia, Irene Gonzalez-Munoza, Carlos Hernandez, Luis Huguet, Jose M Morales, Victor J Sicilia, Beatriz Vega, Pablo Vera, Isabel Zabana, Yamile Nos, Pilar Suarez Alvarez, Patricia Calvino-Suarez, Cristina Ricart, Elena Hernandez, Vicent Minguez, Miguel Marquez, Lucia Hervias Cruz, Daniel Rubio Iturria, Saioa Barrio, Jesus Gargayo-Puyuelo, Carla Frances, Ruben Hinojosa, Esther Del Moral, Maria Calvet, Xavier Algaba, Alicia Aldeguer, Xavier Guardiola, Jordi Manosa, Miriam Pajares, Ramon Piqueras, Marta Garcia-Bosch, Orlando Lopez Serrano, Pilar Castro, Beatriz Lucendo, Alfredo J Montoro, Miguel Castro Ortiz, Elena Mesonero, Francisco Garcia-Planella, Esther Fuentes, David A Bort, Inmaculada Delgado-Guillena, Pedro Arias, Lara Iglesias, Agueda Calvo, Marta Esteve, Maria Domenech, Eugeni Gisbert, Javier P |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Ustekinumab ulcerative colitis response remission durability real-world evidence |
| topic |
Ustekinumab ulcerative colitis response remission durability real-world evidence |
| description |
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. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://incliva.portalinvestigacion.com/publicaciones/15678 |
| url |
https://incliva.portalinvestigacion.com/publicaciones/15678 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.publisher.none.fl_str_mv |
OXFORD UNIV PRESS |
| publisher.none.fl_str_mv |
OXFORD UNIV PRESS |
| dc.source.none.fl_str_mv |
Journal of Crohns & Colitis ISSN: 18739946 ISSNe: 18764479 reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA instname:INCLIVA |
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INCLIVA |
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r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
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r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
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|
| repository.mail.fl_str_mv |
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| _version_ |
1869403131065925632 |
| score |
15,198674 |