Value of tofacitinib extended induction therapy in patients with moderate-to-severe ulcerative colitis: A real-world 52-week follow-up study
Year: 2025
Type: article
Study design: Observational Study
Abstract: BACKGROUND Tofacitinib is an oral, selective Janus kinase inhibitor that is approved for the treatment of ulcerative colitis (UC). The 8-week induction protocol involves the administration of 10 mg twice daily (bid) with the possibility of extending the induction period to 16 weeks. The maintenance dose of tofacitinib is either 5 mg or 10 mg bid. AIM To assess predictors for clinical remission and drug persistence in patients with UC receiving the extended induction tofacitinib protocol. METHODS This was a real-world multicenter retrospective study in patients with moderate-to-severe UC. Patients received physician-directed extended induction tofacitinib treatment. We collected clinical and demographic data at baseline and data regarding clinical, laboratory, and endoscopic evaluations, therapeutic modifications, and adverse events at the 52-week follow-up. Possible predictors for clinical remission at week 52 was the primary endpoint. Differences between patients receiving 5 mg bid vs 10 mg bid at week 52 and identification of predictors for treatment persistence were secondary endpoints. RESULTS Thirty-seven consecutive patients from 11 medical centers were included [51.4% males with median age 39 (17-64) years]. Twenty-eight patients continued treatment until week 52 (75.7%) with 67.9% receiving 10 mg tofacitinib; all had prior history of biologic use. We observed that 57.1% of patients achieved clinical remission (66.7% in the 5 mg tofacitinib group and 52.6% in the 10 mg tofacitinib group, P = 0.483). De-escalation to 5 mg tofacitinib was attempted in 17 patients with a success rate of 52.9%. Prior biologic use was significantly more frequent in patients treated with 10 mg tofacitinib. Active smoking was significantly associated with treatment discontinuation at week 52. We identified eight adverse events, and only one led to treatment discontinuation. CONCLUSION Our results supported the extended induction strategy with tofacitinib in selected patients with UC. Patients with prior failure of advanced therapies particularly benefitted, highlighting the importance of personalized maintenance regimens.
Authors: Maria Tzouvala, Eirini Zacharopoulou, Maria Kalafateli, Nikos Viazis, Andreas Psistakis, Angeliki Theodoropoulou, Ioannis Drygiannakis, Konstantinos Karmiris, Ioannis E Koutroubakis, Polyxeni Kevrekidou, Kostas Soufleris, Marios Katsaros, Olga Giouleme, Fotios Fousekis, Konstantinos Katsanos, Dimitrios Christodoulou, Aikaterini Gaki, Evgenia Papathanasiou, Giorgos Bamias, Evanthia Zampeli, Spyridon Michopoulos, Nikolaos Kyriakos, Christos Veretanos, Konstantinos Argyriou, Andreas Kapsoritakis, George Tribonias, Gerassimos J Mantzaris, Christos Liatsos
Institutions: General Hospital of Nikea, Imperial College London, Polyclinic General Hospital, Evangelismos Hospital, The General Hospital of Heraklion "Venizeleio-Pananio", University Hospital of Heraklion, Theageneio General Hospital, Aristotle University of Thessaloniki, University of Ioannina, University Hospital of Ioannina, National and Kapodistrian University of Athens, Sotiria General Hospital, Alexandra Hospital, 401 General Military Hospital of Athens, University Hospital of Larissa, Hellenic Red Cross, Red Cross Hospital
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4416156263