María Chaparro1, Ana Garre1, Francisco Mesonero2, Cristina Rodríguez3, Manuel Barreiro-de Acosta4, Jesús Martínez-Cadilla5, María T Arroyo6, Noemí Manceñido7, Mónica Sierra-Ausín8, Isabel Vera-Mendoza9, María José Casanova1, Pilar Nos10, Carlos González-Muñoza11, Teresa Martínez12, Maia Boscá-Watts13, Margalida Calafat14, David Busquets15, Eva Girona16, Jordina Llaó17, María Dolores Martín-Arranz18, Marta Piqueras19, Laura Ramos20, Gerard Surís21, Fernando Bermejo22, Ana Y Carbajo23, Diego Casas-Deza24, Agnes Fernández-Clotet25, María J García26, Daniel Ginard27, Ana Gutiérrez-Casbas28, Luis Hernández29, Alfredo J Lucendo30, Lucía Márquez31, Olga Merino-Ochoa32, Francisco J Rancel33, Carlos Taxonera34, Antonio López Sanromán2, Saioa Rubio3, Eugeni Domènech14, Javier P Gisbert1. 1. Gastroenterology Department, 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. 2. Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. 3. Gastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain. 4. Gastroenterology Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain. 5. Gastroenterology Department, Hospital Álvaro Cunqueiro-Complexo Hospitalario Universitario de Vigo, Vigo, Spain. 6. Gastroenterology Department, Hospital Clínico Universitario Lozano Blesa and CIBERehd, IIS Aragón, Zaragoza, Spain. 7. Gastroenterology Department, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain. 8. Gastroenterology Department, Complejo Asistencial Universitario de León, León Spain. 9. Gastroenterology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain. 10. Gastroenterology Department, Hospital Universitario y Politécnico La Fe and CIBERehd, Valencia, Spain. 11. Gastroenterology Department, Hospital Universitario Santa Creu i Sant Pau, Barcelona, Spain. 12. Gastroenterology Department, Hospital Virgen de la Luz, Cuenca, Spain. 13. Gastroenterology Department, Hospital Clinico de Valencia and Universitat de Valencia, Valencia, Spain. 14. Gastroenterology Department, Hospital Universitari Germans Trials i Pujol and CIBERehd, Badalona, Barcelona, Spain. 15. Gastroenterology Department, Hospital Universitario de Gerona Dr Josep Trueta, Girona, Spain. 16. Gastroenterology Department, Hospital General Universitario de Elche, Alicante, Spain. 17. Gastroenterology Department, Hospital Sant Joan de Déu, Althaia, Xarxa Assistencial Universitària de Manresa, Barcelona, Spain. 18. Department of Gastroenterology, and Innate Immunity Group, IdiPAZ Institute for Health Research, La Paz Hospital, Madrid, Spain. 19. Gastroenterology Department, Consorci Sanitari de Terrasa, Barcelona, Spain. 20. Gastroenterology Department, Hospital Universitario de Canarias, Islas Canarias, Spain. 21. Gastroenterology Department, Hospital de Bellvitge and IDIBELL, L'Hospitalet, Spain. 22. Gastroenterology Department, Hospital Universitario de Fuenlabrada, Instituto de Investigación Sanitaria del Hospital La Paz [IdiPaz], Madrid, Spain. 23. Gastroenterology Department, Hospital Universitario Río Hortega, Valladolid, Spain. 24. Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain. 25. Gastroenterology Department, Hospital Clìnic de Barcelona, Barcelona, Spain. 26. Gastroenterology Department, Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain. 27. Gastroenterology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain. 28. Gastroenterology Department, Hospital General Universitario de Alicante and CIBERehd, Alicante, Spain. 29. Gastroenterology Department, Hospital Santos Reyes de Aranda del Duero, Burgos, Spain. 30. Gastroenterology Department, Hospital General de Tomelloso, IIS-IP and CIBEREHD Ciudad Real, Spain. 31. Gastroenterology Department, Hospital del Mar and Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain. 32. Gastroenterology Department, Hospital Universitario de Cruces, Vizcaya, Spain. 33. Gastroenterology Department, Complejo Hospitalario de Palencia, Palencia, Spain. 34. Gastroenterology Department, Hospital Clínico San Carlos and IdISSC, Madrid, Spain.
Abstract
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.
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.
Authors: Laura A Lucaciu; Nathan Constantine-Cooke; Nikolas Plevris; Spyros Siakavellas; Lauranne A A P Derikx; Gareth-Rhys Jones; Charles W Lees Journal: Therap Adv Gastroenterol Date: 2021-12-23 Impact factor: 4.409
Authors: Remo Panaccione; Maria T Abreu; Irina Lazariciu; Rajiv Mundayat; Nervin Lawendy; Leonardo Salese; John C Woolcott; Bruce E Sands; María Chaparro Journal: Aliment Pharmacol Ther Date: 2022-03-05 Impact factor: 9.524