Title :

Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis

Author(s) :

Lair-Mehiri, Loriane [Auteur]
Stefanescu, Carmen [Auteur]
Vaysse, Thibaut [Auteur]
Laharie, David [Auteur]
Roblin, Xavier [Auteur]
Rosa, Isabelle [Auteur]
Treton, Xavier [Auteur]
Abitbol, Vered [Auteur]
Amiot, Aurelien [Auteur]
Bouguen, Guillaume [Auteur]
Dib, Nina [Auteur]
Fumery, Mathurin [Auteur]
Pariente, Benjamin [Auteur]
Carbonnel, Franck [Auteur]
Peyrin-Biroulet, Laurent [Auteur]
Simon, Marion [Auteur]
Viennot, Stephanie [Auteur]
Bouhnik, Yoram [Auteur]

Journal title :

Digestive and liver disease . official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

Abbreviated title :

Dig Liver Dis

Publication date :

2019-11-12

ISSN :

1878-3562

English keyword(s) :

Refractory ulcerative colitis
Janus kinase inhibitor

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Phase III trials demonstrated effectiveness of tofacitinib, an oral Janus kinase inhibitor, to induce and maintain remission in patients with moderate-to-severe active ulcerative colitis (UC). We report the real-world ...
Show more >Phase III trials demonstrated effectiveness of tofacitinib, an oral Janus kinase inhibitor, to induce and maintain remission in patients with moderate-to-severe active ulcerative colitis (UC). We report the real-world effectiveness and safety of tofacitinib in patients with UC in France. From February 2017 to December 2018, we performed a national French cohort study, which included all consecutive patients with an active UC refractory to anti-TNF and vedolizumab, who received tofacitinib. Outcomes were survival without colectomy, survival without tofacitinib discontinuation and steroid-free clinical remission at weeks 14, 24 and 48. Thirty-eight patients were included, with a median follow-up of 41.5 (18.5-56.8) weeks. Survival without colectomy was 77% [95% confidence interval (95%CI): 59.3-87.9] at week 24 and 70% (95%CI: 50.9-82.8) at week 48. Survival without treatment discontinuation was 70% (95%CI: 52.6-82.3) at week 24. Steroid-free clinical remission was observed in 13 (34%) patients at week 48. Adverse events occurred in 14 (37%) patients, including 6 severe adverse events and three herpes zoster infections. In a highly refractory UC population, one third of patients treated with tofacitinib achieved steroid-free clinical remission at week 14 and 70% of patients avoided colectomy at one year, with an acceptable safety profile. These data confirm tofacitinib effectiveness in UC, especially after multiple biologic failures.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Inserm
Université de Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-30T10:28:26Z