Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study
Tamás Resál, Péter Bacsúr, Csilla Keresztes, Anita Bálint, Renáta Bor, Anna Fábián, Bernadett Farkas, Kostas Katsanos, George Michalopoylos, Davide Giuseppe Ribaldone, Mohamed Attauabi, Mirabella Zhao, Hadar Amir Barak, Henit Yanai, Cristina Bezzio, Antonio Rispo, Fabiana Castiglione, Ariella Bar‐Gil Shitrit, Daniela Pugliese, Alessandro Armuzzi, Edoardo Savarino, Martin Kolář, Milan Lukáš, E. Yu. Chashkova, Rafał Filip, Aurore Rozières, Stéphane Nancey, Željko Krznarić, Eszter Schäfer, T Szamosi, Patrícia Sarlós, M Franko, David Drobne, O. V. Knyazev, A Kagramanova, Jimmy K. Limdi, Panu Wetwittayakhlang, Péter L. Lakatos, Nitsan Maharshak, Lian Bannon, Tibor Nyári, Zoltán Szepes, Klaudia Farkas, TFB Study Group, Simone Saibeni, Kristyna Kastylova, Jakob Benedict Seidelin, Johan Burisch, Helga Hajdú, Tamás Molnár
Abstract
BACKGROUND AND AIMS: Tofacitinib (TFB) appears to be effective in the treatment of ulcerative colitis (UC); however, available real-world studies are limited by cohort size. TFB could be an option in the treatment of acute severe ulcerative colitis (ASUC). We aimed to investigate efficacy and safety of TFB in moderate-to-severe colitis and ASUC. METHODS: This retrospective, international cohort study enrolling UC patients with ≥6-week follow-up period was conducted from February 1 to July 31, 2022. Indications were categorized as ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Steroid-free remission (SFR), colectomy, and safety data were analyzed. RESULTS: A total of 391 UC patients (median age 38 [interquartile range, 28-47] years; follow-up period 26 [interquartile range, 14-52] weeks) were included. A total of 27.1% received TFB in ASUC. SFR rates were 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. The baseline partial Mayo score (odds ratio [OR], 0.850; P = .006) was negatively associated with week 12 SFR, while biologic-naïve patients (OR, 2.078; P = .04) more likely achieved week 52 SFR. The colectomy rate at week 52 was higher in ASUC group (17.6% vs 5.7%; P < .001) and decreased with age (OR, 0.94; P = .013). A total of 67 adverse events were reported, and 17.9% resulted in cessation of TFB. One case of thromboembolic event was reported. CONCLUSIONS: TFB is effective in both studied indications. TFB treatment resulted in high rates of SFR in the short and long terms. Higher baseline disease activity and previous biological therapies decreased efficacy. No new adverse event signals were found.