Safety and effectiveness of tofacitinib in ulcerative colitis: Data from TOFA-UC, a SN-IBD study.

Background: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC).
Aim: To assess the safety and effectiveness of TOFA in clinical practice.
Methods: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included.
Results: 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response.
Conclusions: TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies.
Competing Interests: Conflict of interest Fabio Salvatore Macaluso served as an advisory board member and/or received lecture grants from Biogen, Ferring, Galapagos, Janssen, MSD, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals. Walter Fries served as an advisory board member and/or received lecture grants from Abbvie, MSD, Takeda, Pfizer, Biogen, Sandoz, Zambon, Ferring Italia, Sofar. Anna Viola received lecture grants from Pfizer. Maria Cappello served as an advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi, and Takeda Pharmaceuticals. Filippo Mocciaro served as an advisory board member for Janssen and Galapagos, and received lecture grants from Takeda Pharmaceuticals. Antonino Carlo Privitera served as consultant to Mundipharma, Abbvie, MSD, Takeda, and Janssen, and received lecture fees from Abbvie, Sara Renna served as an advisory board member for AbbVie, Janssen, and MSD Pharmaceuticals, and received lecture grants from AbbVie, Janssen, MSD, Pfizer, and Takeda Pharmaceuticals. Ambrogio Orlando served as an advisory board member for AbbVie, Galapagos, MSD, Janssen, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals, and received lecture grants from AbbVie, Fresenius Kabi, Galapagos, MSD, Sofar, Chiesi, Janssen, Pfizer, and Takeda Pharmaceuticals.
(Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)