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.
Keywords
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Article info
Publication history
Published online: November 12, 2019
Accepted:
October 8,
2019
Received:
August 7,
2019
Identification
Copyright
© 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
