Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety.

Autor:	Chaparro M; Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain., Acosta D; Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain., Rodríguez C; Hospital Universitario de Navarra (HUN), Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain., Mesonero F; Hospital Universitario Ramón y Cajal, Madrid, Spain., Vicuña M; Hospital Universitario de Navarra (HUN), Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain., Barreiro-de Acosta M; Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain., Fernández-Clotet A; Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and CIBERehd, Barcelona, Spain., Hernández Martínez Á; Hospital Universitario Torrecárdenas, Almería, Spain., Arroyo M; Hospital Clínico Universitario Lozano Blesa and Fundación del Instituto de Investigación Sanitaria de Aragón (IIS Aragón) and CIBEREHD, Zaragoza, Spain., Vera I; Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., Ruiz-Cerulla A; Hospital Universitario de Bellvitge, L´Hospitalet de Llobregat, Barcelona, Spain., Sicilia B; Hospital Universitario de Burgos, Burgos, Spain., Cabello Tapia MJ; Hospital Universitario Virgen de las Nieves, Granada, Spain., Muñoz Villafranca C; Hospital Universitario de Basurto, Bilbao, Spain., Castro-Poceiro J; Hospital Sant Joan Despí-Moisès Broggi, Barcelona, Spain., Martínez Cadilla J; Hospital Álvaro Cunqueiro, Xerencia Xestión Integrada de Vigo, SERGAS. Grupo de Investigación en Patología Digestiva, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain., Sierra-Ausín M; Complejo Asistencial Universitario de León, Spain., Vázquez Morón JM; Hospital Universitario Juan Ramón Jiménez, Huelva, Spain., Vicente Lidón R; Hospital Universitario Miguel Servet, Zaragoza, Spain., Bermejo F; Hospital Universitario de Fuenlabrada and IdiPAZ, Madrid, Spain., Royo V; Hospital Universitari Son Espases, Palma, Islas Baleares, Spain., Calafat M; Hospital Universitari Germans Trias i Pujol and CIBEREHD, Badalona, Spain., González-Muñoza C; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Leo Carnerero E; Hospital Universitario Virgen del Rocío, Sevilla, Spain., Manceñido Marcos N; Hospital Universitario Infanta Sofía, Madrid, Spain., Torrealba L; Hospital Universitario Dr. Josep Trueta, Girona, Spain., Alonso-Galán H; Hospital Universitario Donostia, Instituto Biodonostia, San Sebastián, Guipúzcoa, Spain., Benítez JM; Hospital Universitario Reina Sofía, IMIBIC, Córdoba, Spain., Ber Nieto Y; Hospital San Jorge, Huesca, Spain., Diz-Lois Palomares MT; Complejo Hospitalario Universitario A Coruña, A Coruña, Spain., García MJ; Hospital Universitario Marqués de Valdecilla and Instituto de Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain., Muñoz JF; Hospital Universitario de Salamanca, Salamanca, Spain., Armesto González EM; Hospital San Agustín, Avilés, Asturias, Spain., Calvet X; Hospital Universitari Parc Taulí, Sabadell, Universitat Autònoma de Barcelona and CIBERehd, Spain., Hernández-Camba A; Complejo Hospitalario Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain., Madrigal Domínguez RE; Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Menchén L; Hospital General Universitario e Instituto de Investigación Sanitaria Gregorio Marañón, y Universidad Complutense, Madrid, Spain., Pérez Calle JL; Hospital Universitario Fundación Alcorcón, Madrid, Spain., Piqueras M; Consorci Sanitari de Terrassa, Barcelona, Spain., Dueñas Sadornil C; Hospital San Pedro de Alcántara, Cáceres, Spain., Botella B; Hospital Universitario Infanta Cristina, Madrid, Spain., Martínez-Pérez TJ; Hospital Virgen de la Luz, Cuenca, Spain., Ramos L; Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain., Rodríguez-Grau MC; Hospital Universitario del Henares, Madrid, Spain., San Miguel E; Hospital Universitario de Getafe, Madrid, Spain., Fernández Forcelledo JL; Hospital Sierrallana de Torrelavega, Cantabria, Spain., Fradejas Salazar PM; Hospital Virgen de la Concha, Zamora, Spain., García-Sepulcre M; Hospital General Universitario de Elche, Alicante, Spain., Gutiérrez A; Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), and CIBERehd, Alicante, Spain., Llaó J; Althaia Xarxa Assistencial Universitaria de Manresa, Barcelona, Spain., Sesé Abizanda E; Hospital Universitario Arnau de Vilanova, Lleida, Spain., Boscá-Watts M; Hospital Clínico de Valencia, Valencia, Spain., Iyo E; Hospital Comarcal de Inca, Islas Baleares, Spain., Keco-Huerga A; Hospital de Valme, Sevilla, Spain., Martínez Bonil C; Hospital General Universitario Los Arcos del Mar Menor, Murcia, Spain., Peña González E; Hospital Royo Villanova, Zaragoza, Spain., Pérez-Galindo P; Complexo Hospitalario Universitario de Pontevedra, Galicia, Spain., Varela P; Hospital Universitario de Cabueñes, Gijón, Spain., Gisbert JP; Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Jazyk:	angličtina
Zdroj:	The American journal of gastroenterology [Am J Gastroenterol] 2023 Jul 01; Vol. 118 (7), pp. 1237-1247. Date of Electronic Publication: 2022 Dec 14.
DOI:	10.14309/ajg.0000000000002145
Abstrakt:	Introduction: The objective of this study was to assess the durability, short-term and long-term effectiveness, and safety of tofacitinib in ulcerative colitis (UC) in clinical practice. Methods: This is a retrospective multicenter study including patients with UC who had received the first tofacitinib dose at least 8 weeks before the inclusion. Clinical effectiveness was based on partial Mayo score. Results: A total of 408 patients were included. Of them, 184 (45%) withdrew tofacitinib during follow-up (mean = 18 months). The probability of maintaining tofacitinib was 67% at 6 m, 58% at 12 m, and 49% at 24 m. The main reason for tofacitinib withdrawal was primary nonresponse (44%). Older age at the start of tofacitinib and a higher severity of clinical activity were associated with tofacitinib withdrawal. The proportion of patients in remission was 38% at week 4, 45% at week 8, and 47% at week 16. Having moderate-to-severe vs mild disease activity at baseline and older age at tofacitinib start were associated with a lower and higher likelihood of remission at week 8, respectively. Of 171 patients in remission at week 8, 83 (49%) relapsed. The probability of maintaining response was 66% at 6 m and 54% at 12 m. There were 93 adverse events related to tofacitinib treatment (including 2 pulmonary thromboembolisms [in patients with risk factors] and 2 peripheral vascular thrombosis), and 29 led to tofacitinib discontinuation. Discussion: Tofacitinib is effective in both short-term and long-term in patients with UC. The safety profile is similar to that previously reported. (Copyright © 2023 by The American College of Gastroenterology.)
Databáze:	MEDLINE
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