Tofacitinib as salvage therapy for 55 patients hospitalised with refractory severe ulcerative colitis: A GETAID cohort.

Abstract

BACKGROUND:

Up to 25% of patients with ulcerative colitis (UC) will require hospitalization for severe flare. In patients hospitalised for severe flare, who previously experienced multiple drug failures, including steroids and anti-TNF agents, new quick-acting medical options are needed. Tofacitinib is effective in refractory UC and has a rapid onset of action.

AIM:

To evaluate effectiveness and safety of tofacitinib as rescue therapy in patients hospitalised for UC flare.

METHODS:

We conducted an observational and multicentre study with both retrospective and prospective collections in 14 GETAID centres. The primary objective was to assess the survival without colectomy following tofacitinib initiation in patients hospitalised for a UC flare. We determined rates of clinical response, clinical remission, and steroid-free clinical remission at week 6 and week 14 and safety.

RESULTS:

Fifty-five patients were included (49 with prior infliximab failure and 19 previously exposed to ciclosporin). With a median follow-up of 6.5 months (interquartile range [IQR] [3-12.3]), rate of colectomy-free survival was estimated at 78.9% (95 CI [68.5-90.9]) and 73.6% (95 CI [61.9-87.3]) at 3 and 6 months, respectively. Rates of clinical response, clinical remission and steroid-free clinical remission were 60%, 45.5% and 37.5% at week 6 and 41.8%, 34.5% and 32.7% at week 14. Regarding safety, no death was observed, three patients withdrew tofacitinib due to adverse events. Two herpes zoster infections occurred in patients aged over 60 years old. No venous thrombotic or major adverse cardiovascular events occurred.

CONCLUSION:

Tofacitinib appears as a promising option in patients hospitalised with a UC flare but needs further validation in controlled trials.

• Authors: Mathieu Uzzan, Clément Bresteau, David Laharie, Carmen Stefanescu, Christophe Bellanger, Franck Carbonnel, Mélanie Serrero, Stéphanie Viennot, Maria Nachury, Aurélien Amiot, Romain Altwegg, Laurence Picon, Stéphane Nahon, Lucine Vuitton, Philippe Ah Soune, Julien Kirchgesner, Laurent Peyrin-Biroulet, Yoram Bouhnik, GETAID-TALC Study Group
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 54 Issue 3 Pg. 312-319 (08 2021) ISSN: 1365-2036 [Electronic] England
• PMID: 34151448 (Publication Type: Journal Article, Multicenter Study)
• Copyright: © 2021 John Wiley & Sons Ltd.

Chemical References

• Piperidines
• Pyrimidines
• Tumor Necrosis Factor Inhibitors
• tofacitinib
• Infliximab

Topics

• Aged
• Colectomy
• Colitis, Ulcerative (drug therapy, surgery)
• Humans
• Infliximab
• Middle Aged
• Piperidines
• Prospective Studies
• Pyrimidines
• Retrospective Studies
• Salvage Therapy
• Treatment Outcome
• Tumor Necrosis Factor Inhibitors