Background/Aims Tofacitinib and upadacitinib are small-molecule compounds that inhibit the Janus kinase pathway for the treatment of refractory ulcerative colitis. Only a few reports have compared the efficacy and safety of these 2 drugs in real-world practice. We aimed to show our real-world evidence of these drugs and compare the efficacy and safety profiles in the treatment of ulcerative colitis.
Methods This study is a single-center retrospective analysis. Patients treated with tofacitinib or upadacitinib at our hospital between June 2018 and January 2024 who were monitored for 24 weeks were included. The primary outcome was steroid-free clinical remission at 24 weeks. Secondary outcomes were response and remission rates at each time point, time series changes in partial Mayo scores and laboratory results, treatment survival at 24 weeks, and the incidence of adverse events.
Results A total of 68 patients treated with tofacitinib and 34 patients treated with upadacitinib were included. Steroid-free clinical remission rate at 24 weeks was significantly higher in upadacitinib-treated patients than in tofacitinibtreated patients (64.7% vs. 38.2%). The response rates in upadacitinib-treated patients exceeded 60% after 8 weeks of treatment through to 24 weeks, and the rates were higher than those in tofacitinib-treated patients. The incidences of adverse events were 79.4% in upadacitinib-treated patients and 38.2% in tofacitinib-treated patients. The most common adverse event was acne for upadacitinib.
Conclusions Upadacitinib was more effective than tofacitinib in inducing remission in ulcerative colitis patients. The incidence of adverse events was significantly higher with upadacitinib than tofacitinib.
Citations
Citations to this article as recorded by
Janus Kinase Inhibitors for Inflammatory Bowel Disease: Concise Questions and Answers on Their Use in Clinical Practice Javier P Gisbert, María Chaparro Inflammatory Bowel Diseases.2026; 32(4): 775. CrossRef
Optimal use and cycling strategies of Janus kinase inhibitors in ulcerative colitis: current evidence and clinical implications from the KASID Guidelines Task Force Team Seung Min Hong, Dong Hyun Kim, June Hwa Bae, Seung Yong Shin, Eun Mi Song, Ji Eun Kim, Young Joo Yang, Jiyoung Yoon, Sang-Bum Kang, Eun Soo Kim, Seong-Eun Kim, Seong-Jung Kim, Jun Lee, Soo-Young Na, Soo Jung Park, Sang Hyoung Park, Miyoung Choi, Myung Ha Intestinal Research.2026; 24(1): 27. CrossRef
Incidence of acne in patients with inflammatory bowel disease treated with Janus kinase inhibitors: a systematic review and meta-analysis Mohammed Nabil Quraishi, Maryam A Alahmad, Thaer Khaleel Swaid, Antonio Facciorusso, Alyssa A Grimshaw, Badr Al-Bawardy Inflammatory Bowel Diseases.2026;[Epub] CrossRef
Upadacitinib after tofacitinib in ulcerative colitis Hyeon Jin Cho, Eun Soo Kim Intestinal Research.2025; 23(3): 229. CrossRef
Comparative effectiveness and safety of tofacitinib and filgotinib in patients with ulcerative colitis: A propensity score-weighted cohort study Fabio Salvatore Macaluso, Walter Fries, Anna Viola, Clara De Francesco, Nunzio Belluardo, Emiliano Giangreco, Maria Cappello, Roberto Ajovalasit, Filippo Mocciaro, Barbara Scrivo, Antonino Carlo Privitera, Maria Emanuela Distefano, Alessandro Vitello, Con Digestive and Liver Disease.2025; 57(11): 2109. CrossRef
Tofacitinib in acute severe ulcerative colitis: review addressing seven key unmet needs Chuong Dinh Nguyen, Luan Minh Dang, Thong Duy Vo, Hoang Huu Bui, Eun Soo Kim, Joyce Wing Yan Mak, Choon Jin Ooi Therapeutic Advances in Gastroenterology.2025;[Epub] CrossRef
Successful treatment of tofacitinib-refractory scleritis associated with multiple systemic inflammatory diseases using upadacitinib Kodai Yuge, Nobuyo Yawata, Kenichiro Asahara, Satoshi Yamana, Nobuyuki Ono, Koh-Hei Sonoda Immunological Medicine.2025; : 1. CrossRef
Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective Shintaro Akiyama Intestinal Research.2025;[Epub] CrossRef
Upadacitinib versus Tofacitinib in the Management of Ulcerative Colitis: A Systematic Review and Meta-Analysis Tareq Alsaleh, Abdul Mohammed, Aimen Farooq, Magda Elamin, Amr Akl, Karim Mohamed Yassin, Ahmed Elnaggar, Jennifer Seminerio Inflammatory Intestinal Diseases.2025; 11(1): 29. CrossRef