Intestinal Research

Original Articles

The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi; Received August 9, 2024 Accepted March 20, 2025 Published online June 4, 2025; DOI: https://doi.org/10.5217/ir.2024.00126 [Epub ahead of print]

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Background/Aims
Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon-naïve patients.
Methods
This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.
Results
A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).
Conclusions
The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363)

Citations

Citations to this article as recorded by

Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef
Long-Term Outcomes and Prognostic Factors for Vedolizumab-Treated Japanese Patients with Ulcerative Colitis
Shinya Fukushima, Takehiko Katsurada, Takahiro Ito, Atsuo Maemoto, Fumika Orii, Toshifumi Ashida, Masanao Nasuno, Hiroki Tanaka, Katsuyoshi Ando, Mikihiro Fujiya, Yoshihiro Yokoyama, Satoshi Motoya, Hiroshi Nakase
Inflammatory Intestinal Diseases.2025; 11(1): 1. CrossRef

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IBD

Comparative short-term efficacy of upadacitinib versus tofacitinib for ulcerative colitis: a 24-week real-world study in Japan: Akiko Tamura, Hiromichi Shimizu, Toshimitsu Fujii, Ami Kawamoto, Ryo Morikawa, Shuji Hibiya, Kento Takenaka, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto; Intest Res 2026;24(1):95-102. Published online March 20, 2025; DOI: https://doi.org/10.5217/ir.2024.00187

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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

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IBD

Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study: Hiromichi Shimizu, Yuko Aonuma, Shuji Hibiya, Ami Kawamoto, Kento Takenaka, Toshimitsu Fujii, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto; Intest Res 2024;22(3):369-377. Published online July 16, 2024; DOI: https://doi.org/10.5217/ir.2023.00194

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Background/Aims
The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
Methods
A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events.
Results
Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study.
Conclusions
Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice.

Citations

Citations to this article as recorded by

Comparative short-term efficacy of upadacitinib versus tofacitinib for ulcerative colitis: a 24-week real-world study in Japan
Akiko Tamura, Hiromichi Shimizu, Toshimitsu Fujii, Ami Kawamoto, Ryo Morikawa, Shuji Hibiya, Kento Takenaka, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
Intestinal Research.2026; 24(1): 95. 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
The Evolving Landscape of Advanced Therapies in Inflammatory Bowel Disease: Current Evidence and Emerging Targets
Daniele Balducci, Marta Mosca, Sabrina Monaco, Susanna Faenza, Stefano Fabiani, Fabio Cortellini, Nicola Cesaro, Gianpiero Stefanelli, Salvatore Paba, Maddalena Pecchini, Michele Montori, Marco Valvano
Gastrointestinal Disorders.2026; 8(1): 13. CrossRef
In which patients with ulcerative colitis would filgotinib be effective?
Jihye Park
Intestinal Research.2025; 23(1): 1. CrossRef
Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety
Rogério Serafim Parra, Renata de Sá Brito Fróes, Daniela Oliveira Magro, Sandro da Costa Ferreira, Munique Kurtz de Mello, Matheus Freitas Cardoso de Azevedo, Aderson Omar Mourão Cintra Damião, Alexandre de Sousa Carlos, Luísa Leite Barros, Maria Luiza Qu
BMC Gastroenterology.2025;[Epub] CrossRef
State-of-the-Art Evidence for Clinical Outcomes and Therapeutic Implications of Janus Kinase Inhibitors in Moderate-to-Severe Ulcerative Colitis: A Narrative Review
Yunseok Choi, Suhyun Lee, Hyeon Ji Kim, Taemin Park, Won Gun Kwack, Seungwon Yang, Eun Kyoung Chung
Pharmaceuticals.2025; 18(5): 740. CrossRef
Endo-histologic outcomes in patients with ulcerative colitis responding to tofacitinib
Arshdeep Singh, Arshia Bhardwaj, Devanshi Jain, Riya Sharma, Dharmatma Singh, Ramit Mahajan, Kirandeep Kaur, Aminder Singh, Vikram Narang, Harpreet Kaur, Manavjot Singh, Pritish Gupta, Tanisha Sehgal, Vandana Midha, Ajit Sood
Indian Journal of Gastroenterology.2025;[Epub] CrossRef
Exploring the Factors Associated With the Discontinuation of Tofacitinib in Patients With Rheumatoid Arthritis: A Retrospective Cohort Study
Li‐Huei Chiang, Chia‐Ling Yu, Tzu‐Cheng Tsai, Yao‐Fan Fang
International Journal of Rheumatic Diseases.2025;[Epub] CrossRef
Toward Precision Medicine: Molecular Biomarkers of Response to Tofacitinib in Inflammatory Bowel Disease
Anja Bizjak, Boris Gole, Gregor Jezernik, Uroš Potočnik, Mario Gorenjak
Genes.2025; 16(8): 908. 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
Three Janus kinase inhibitors in ulcerative colitis: is upadacitinib taking the lead?
Yoon Suk Jung
Intestinal Research.2025; 23(4): 394. CrossRef
Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective
Shintaro Akiyama
Intestinal Research.2025;[Epub] CrossRef
Reevaluating aminosalicylates role in maintaining remission in ulcerative colitis: Systematic review and meta-analysis in the era of biologics
Themba Mudege, Jonathan Soldera
World Journal of Meta-Analysis.2025;[Epub] CrossRef
Drug-induced liver injury in inflammatory bowel disease: Challenges in diagnosis and monitoring
Arshdeep Singh, Arshia Bhardwaj, Harmeet Kaur, Ashutosh Bawa, Vandana Midha, Ajit Sood
World Journal of Hepatology.2025;[Epub] CrossRef

9,809 View
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