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Title: Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis. Author: Lair-Mehiri L, Stefanescu C, Vaysse T, Laharie D, Roblin X, Rosa I, Treton X, Abitbol V, Amiot A, Bouguen G, Dib N, Fumery M, Pariente B, Carbonnel F, Peyrin-Biroulet L, Simon M, Viennot S, Bouhnik Y. Journal: Dig Liver Dis; 2020 Mar; 52(3):268-273. PubMed ID: 31732444. Abstract: BACKGROUND: 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). AIMS: We report the real-world effectiveness and safety of tofacitinib in patients with UC in France. METHODS: 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. RESULTS: 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. CONCLUSION: 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.[Abstract] [Full Text] [Related] [New Search]