Loriane Lair-Mehiri1, Carmen Stefanescu1, Thibaut Vaysse2, David Laharie3, Xavier Roblin4, Isabelle Rosa5, Xavier Treton1, Vered Abitbol6, Aurélien Amiot7, Guillaume Bouguen8, Nina Dib9, Mathurin Fumery10, Benjamin Pariente11, Franck Carbonnel2, Laurent Peyrin-Biroulet12, Marion Simon13, Stéphanie Viennot14, Yoram Bouhnik15. 1. AP-HP, Hôpital Beaujon, Service de gastro-entérologie-MICI, Inserm et Université Paris Diderot, Clichy, France. 2. AP-HP, Hôpital du Kremlin-Bicêtre, Service de gastro-entérologie, Université Paris Sud, France. 3. CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'hépato-gastro-entérologie, Univ. Bordeaux, Pessac, France. 4. CHU de Saint-Etienne, Hôpital Bellevue, Saint-Etienne Cedex 2, France. 5. Centre Hospitalier Intercommunal de Créteil, Service de gastro-entérologie, Créteil, France. 6. AP-HP, Hôpital Cochin, Service de gastro-entérologie, Paris, France. 7. AP-HP, Hôpital Henri Mondor, Service de gastro-entérologie, Université Paris Est-Créteil, Créteil, France. 8. CHU de Rennes, Hôpital Pontchaillou, Service d'hépato-gastro-entérologie, Rennes, France. 9. CHU d'Angers, Service d'hépato-gastro-entérologie, Angers, France. 10. CHU Amiens-Picardie, Service d'hépato-gastro-entérologie-Rond point du Pr Cabrol et Peritox, UFR Médecine, Amiens, France. 11. CHRU de Lille, Hôpital Claude Huriez, Service des maladies de l'appareil digestif, Lille Cedex, France. 12. CHU de Nancy, Hôpital de Nancy, Service d'hépato-gastro-entérologie, Nancy Cedex, France. 13. Institut Mutualiste Montsouris, Service d'hépato-gastro-entérologie, Paris, France. 14. CHU de Caen Normandie, Hôpital Clemenceau, Service d'hépato-gastro-entérologie, Caen, France. 15. AP-HP, Hôpital Beaujon, Service de gastro-entérologie-MICI, Inserm et Université Paris Diderot, Clichy, France. Electronic address: yoram.bouhnik@aphp.fr.
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.
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.
Authors: Edoardo Troncone; Irene Marafini; Giovanna Del Vecchio Blanco; Antonio Di Grazia; Giovanni Monteleone Journal: Clin Exp Gastroenterol Date: 2020-05-05
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: Vince B C Biemans; Jasmijn A M Sleutjes; Annemarie C de Vries; Alexander G L Bodelier; Gerard Dijkstra; Bas Oldenburg; Mark Löwenberg; Adriaan A van Bodegraven; Andrea E van der Meulen-de Jong; Nanne K H de Boer; Nidhi Srivastava; Rachel L West; Tessa E H Römkens; Carmen S Horjus Talabur Horje; Jeroen M Jansen; C Janneke van der Woude; Jildou Hoekstra; Rinse K Weersma; Fiona D M van Schaik; Frank Hoentjen; Marieke J Pierik Journal: Aliment Pharmacol Ther Date: 2020-04-01 Impact factor: 8.171