Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry
Aim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods: Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial May...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | INCLIVA |
| Repositorio: | r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
| OAI Identifier: | oai:incliva.fundanetsuite.com:p15333 |
| Acceso en línea: | https://incliva.portalinvestigacion.com/publicaciones/15333 |
| Access Level: | acceso abierto |
| Palabra clave: | Ttofacitinib ulcerative colitis |
| id |
ES_61fb28a1084d45fc201138efbbb609fa |
|---|---|
| oai_identifier_str |
oai:incliva.fundanetsuite.com:p15333 |
| network_acronym_str |
ES |
| network_name_str |
España |
| repository_id_str |
|
| spelling |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA RegistryChaparro, MariaGarre, AnaMesonero, FranciscoRodriguez, CristinaBarreiro-de Acosta, ManuelMartinez-Cadilla, JesusArroyo, Maria TMancenido, NoemiSierra-Ausin, MonicaVera-Mendoza, IsabelCasanova, Maria JoseNos, PilarGonzalez-Munoza, CarlosMartinez, TeresaBosca-Watts, MaiaCalafat, MargalidaBusquets, DavidGirona, EvaLlao, JordinaMartin-Arranz, Maria DoloresPiqueras, MartaRamos, LauraSuris, GerardBermejo, FernandoCarbajo, Ana YCasas-Deza, DiegoFernandez-Clotet, AgnesGarcia, Maria JGinard, DanielGutierrez-Casbas, AnaHernandez, LuisLucendo, Alfredo JMarquez, LuciaMerino-Ochoa, OlgaRancel, Francisco JTaxonera, CarlosLopez Sanroman, AntonioRubio, SaioaDomenech, EugeniGisbert, Javier PTtofacitinibulcerative colitisAim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods: Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission was assessed at Weeks 4, 8, and 16. Results: A total of 113 patients were included.They were exposed to tofacitinib for a median time of 44 weeks. Response and remission at Week 8 were 60% and 31%, respectively. In multivariate analysis, higher PMS at Week 4 (odds ratio [OR] = 0].2; 95% confidence interval [CI] = 0].1-0.4) was the only variable associated with lower likelihood of achieving remission at Week 8. Higher PMS at Week 4 [OR = 0.5; 95% CI = 0.3-0.7] and higher PMS at Week 8 [OR = 0.2; 95% CI = 0.1-0.5] were associated with lower probability of achieving remission at Week 16. A total of 45 patients [40%] discontinued tofacitinib over time. Higher PMS at Week 8 was the only factor associated with higher tofacitinib discontinuation [hazard ratio = 1.5; 95% CI = 1.3-1.6]. A total of 34 patients had remission at Week 8; of these, 65% had relapsed 52 weeks after achieving remission; the dose was increased to 10 mg/12 h in nine patients, and five of them reached remission again. Seventeen patients had adverse events. Conclusions: Tofacitinib is effective and safe in UC patients in real practice, even in a highly refractory cohort. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure.OXFORD UNIV PRESS2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/15333Journal of Crohns & ColitisISSN: 18739946ISSNe: 18764479reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p153332026-06-07T16:35:31Z |
| dc.title.none.fl_str_mv |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| title |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| spellingShingle |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry Chaparro, Maria Ttofacitinib ulcerative colitis |
| title_short |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| title_full |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| title_fullStr |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| title_full_unstemmed |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| title_sort |
Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry |
| dc.creator.none.fl_str_mv |
Chaparro, Maria Garre, Ana Mesonero, Francisco Rodriguez, Cristina Barreiro-de Acosta, Manuel Martinez-Cadilla, Jesus Arroyo, Maria T Mancenido, Noemi Sierra-Ausin, Monica Vera-Mendoza, Isabel Casanova, Maria Jose Nos, Pilar Gonzalez-Munoza, Carlos Martinez, Teresa Bosca-Watts, Maia Calafat, Margalida Busquets, David Girona, Eva Llao, Jordina Martin-Arranz, Maria Dolores Piqueras, Marta Ramos, Laura Suris, Gerard Bermejo, Fernando Carbajo, Ana Y Casas-Deza, Diego Fernandez-Clotet, Agnes Garcia, Maria J Ginard, Daniel Gutierrez-Casbas, Ana Hernandez, Luis Lucendo, Alfredo J Marquez, Lucia Merino-Ochoa, Olga Rancel, Francisco J Taxonera, Carlos Lopez Sanroman, Antonio Rubio, Saioa Domenech, Eugeni Gisbert, Javier P |
| author |
Chaparro, Maria |
| author_facet |
Chaparro, Maria Garre, Ana Mesonero, Francisco Rodriguez, Cristina Barreiro-de Acosta, Manuel Martinez-Cadilla, Jesus Arroyo, Maria T Mancenido, Noemi Sierra-Ausin, Monica Vera-Mendoza, Isabel Casanova, Maria Jose Nos, Pilar Gonzalez-Munoza, Carlos Martinez, Teresa Bosca-Watts, Maia Calafat, Margalida Busquets, David Girona, Eva Llao, Jordina Martin-Arranz, Maria Dolores Piqueras, Marta Ramos, Laura Suris, Gerard Bermejo, Fernando Carbajo, Ana Y Casas-Deza, Diego Fernandez-Clotet, Agnes Garcia, Maria J Ginard, Daniel Gutierrez-Casbas, Ana Hernandez, Luis Lucendo, Alfredo J Marquez, Lucia Merino-Ochoa, Olga Rancel, Francisco J Taxonera, Carlos Lopez Sanroman, Antonio Rubio, Saioa Domenech, Eugeni Gisbert, Javier P |
| author_role |
author |
| author2 |
Garre, Ana Mesonero, Francisco Rodriguez, Cristina Barreiro-de Acosta, Manuel Martinez-Cadilla, Jesus Arroyo, Maria T Mancenido, Noemi Sierra-Ausin, Monica Vera-Mendoza, Isabel Casanova, Maria Jose Nos, Pilar Gonzalez-Munoza, Carlos Martinez, Teresa Bosca-Watts, Maia Calafat, Margalida Busquets, David Girona, Eva Llao, Jordina Martin-Arranz, Maria Dolores Piqueras, Marta Ramos, Laura Suris, Gerard Bermejo, Fernando Carbajo, Ana Y Casas-Deza, Diego Fernandez-Clotet, Agnes Garcia, Maria J Ginard, Daniel Gutierrez-Casbas, Ana Hernandez, Luis Lucendo, Alfredo J Marquez, Lucia Merino-Ochoa, Olga Rancel, Francisco J Taxonera, Carlos Lopez Sanroman, Antonio Rubio, Saioa 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 |
| dc.subject.none.fl_str_mv |
Ttofacitinib ulcerative colitis |
| topic |
Ttofacitinib ulcerative colitis |
| description |
Aim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods: Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission was assessed at Weeks 4, 8, and 16. Results: A total of 113 patients were included.They were exposed to tofacitinib for a median time of 44 weeks. Response and remission at Week 8 were 60% and 31%, respectively. In multivariate analysis, higher PMS at Week 4 (odds ratio [OR] = 0].2; 95% confidence interval [CI] = 0].1-0.4) was the only variable associated with lower likelihood of achieving remission at Week 8. Higher PMS at Week 4 [OR = 0.5; 95% CI = 0.3-0.7] and higher PMS at Week 8 [OR = 0.2; 95% CI = 0.1-0.5] were associated with lower probability of achieving remission at Week 16. A total of 45 patients [40%] discontinued tofacitinib over time. Higher PMS at Week 8 was the only factor associated with higher tofacitinib discontinuation [hazard ratio = 1.5; 95% CI = 1.3-1.6]. A total of 34 patients had remission at Week 8; of these, 65% had relapsed 52 weeks after achieving remission; the dose was increased to 10 mg/12 h in nine patients, and five of them reached remission again. Seventeen patients had adverse events. Conclusions: Tofacitinib is effective and safe in UC patients in real practice, even in a highly refractory cohort. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure. |
| 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/15333 |
| url |
https://incliva.portalinvestigacion.com/publicaciones/15333 |
| 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 |
| instname_str |
INCLIVA |
| reponame_str |
r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
| collection |
r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
| repository.name.fl_str_mv |
|
| repository.mail.fl_str_mv |
|
| _version_ |
1869409460845281280 |
| score |
15.811543 |