Intestinal Research

Original Article

Upadacitinib induction is effective and safe in ulcerative colitis patients including those with prior exposure to tofacitinib: a multicenter real-world cohort study: Robert Gilmore, Richard Fernandes, Imogen Hartley, Arteen Arzivian, Rupert Leong, Bridgette Andrew, Abhinav Vasudevan, Tessa Greeve, Gregory Thomas Moore, Steven Kim, Daniel Lightowler, Abhey Singh, Gillian Mahy, Aditya Mithanthaya, Kannan Venugopaul, Sangwoo Han, Robert Bryant, Jack West, Jonathan Segal, Britt Christensen, Crispin Corte, Nik Ding, Yoon-Kyo An, Jakob Begun; Received August 12, 2024 Accepted October 7, 2024 Published online December 20, 2024; DOI: https://doi.org/10.5217/ir.2024.00127 [Epub ahead of print]

Background/Aims
Upadacitinib is a novel selective Janus kinase inhibitor approved for use in ulcerative colitis. Clinical trials had rigorous criteria and excluded many patient subgroups. Given limited real-world effectiveness data, we examined outcomes of patients treated with upadacitinib for ulcerative colitis in a real-world population.
Methods
Patients that commenced upadacitinib for moderate-to-severe ulcerative colitis from September 2022 until March 2023 were identified at 13 inflammatory bowel disease centers across Australia. Clinical, biochemical, endoscopic, and intestinal ultrasound outcomes were recorded retrospectively at baseline, week 8, and week 16.
Results
One hundred and fifty-two patients (61 female [40%], median age 38 years [interquartile range, 28–50]) were included. The primary endpoint of clinical remission was met in 79% at week 8, and 84% at week 16. A total of 42 patients (28%) with prior tofacitinib exposure were included. No significant difference in clinical remission was observed by week 16 between tofacitinib experienced compared to tofacitinib naïve patients (86% vs. 84%, P= 0.67). Complete intestinal ultrasound data was available for 36 patients, showing transmural remission in 64% at week 8 and 81% at week 16, with a decrease in median bowel wall thickness of 2.3 mm and 2.4 mm, respectively.
Conclusions
Upadacitinib resulted in high rates of clinical remission at 8 and 16 weeks in this large real-world cohort of ulcerative colitis patients. Upadacitinib is effective in patients with prior tofacitinib exposure. Intestinal ultrasound shows significant rates of transmural remission at week 8, sustained through week 16.

Citations

Citations to this article as recorded by

Letter: Toward Intra‐Class Switching With JAK Inhibitors?
Mathieu Uzzan, David Laharie
Alimentary Pharmacology & Therapeutics.2025; 61(5): 919. CrossRef

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Review

IBD

What to do when traditional rescue therapies fail in acute severe ulcerative colitis: Christopher F. D. Li Wai Suen, Matthew C. Choy, Peter De Cruz; Intest Res 2024;22(4):397-413. Published online May 16, 2024; DOI: https://doi.org/10.5217/ir.2024.00003

Abstract PDF PubReader ePub

Acute severe ulcerative colitis (ASUC) is a medical emergency that affects approximately 25% of patients with ulcerative colitis at some point in time in their lives. Outcomes of ASUC are highly variable. Approximately 30% of patients do not respond to corticosteroids and up to 50% of patients do not respond to rescue therapy (infliximab or cyclosporin) and require emergency colectomy. Data are emerging on infliximab dosing strategies, use of cyclosporin as a bridge to slower acting biologic agents and Janus kinase inhibition as primary and sequential therapy. In this review, we outline contemporary approaches to clinical management of ASUC in the setting of failure to respond to traditional rescue therapies.

Citations

Citations to this article as recorded by

Intensified infliximab induction therapy for steroid-refractory acute severe ulcerative colitis – Authors’ reply
Christopher F D Li Wai Suen, Matthew C Choy, Danny Con, Peter De Cruz
The Lancet Gastroenterology & Hepatology.2025; 10(1): 19. CrossRef
Janus kinase inhibitors in the management of acute severe ulcerative colitis: a comprehensive review
Javier P Gisbert, María Chaparro
Journal of Crohn's and Colitis.2025;[Epub] CrossRef
Sequential rescue therapy with JAK inhibitors in corticosteroid and infliximab-refractory acute severe ulcerative colitis: a case series
Amirah Etchegaray, George Tambakis, Rina Kumar, Anthony Croft, Graham Radford-Smith, Gareth J. Walker
Therapeutic Advances in Gastroenterology.2025;[Epub] CrossRef
Recent Advances in the Management of Acute Severe Ulcerative Colitis
Elaine Ong Ming San, Kassem Sharif, Konstantina Rosiou, Michael Rennie, Christian Philipp Selinger
Journal of Clinical Medicine.2024; 13(23): 7446. CrossRef

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Original Article

IBD

Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial: Toshifumi Hibi, Satoshi Motoya, Tadakazu Hisamatsu, Fumihito Hirai, Kenji Watanabe, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Brian G Feagan, Chantal Tasset, Robin Besuyen, Chohee Yun, Gerald Crans, Jie Zhang, Akira Kondo, Mamoru Watanabe; Intest Res 2023;21(1):110-125. Published online March 11, 2022; DOI: https://doi.org/10.5217/ir.2021.00143

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.

Citations

Citations to this article as recorded by

Quercus infectoria galls mitigates colitis in mice through alleviating mucosal barrier impairment and suppressing inflammatory factors
Yan Ding, Jiao-Jiao Bai, Sabahat Ablimit, Muyassar Yasen, Arfidin Anwar, Kudelaidi Kuerban, Mubarak Iminjan, Guo-Qiang Zhang
Journal of Ethnopharmacology.2025; 343: 119487. CrossRef
Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data
Katsuyoshi Matsuoka, Satoshi Motoya, Takayuki Yamamoto, Minoru Matsuura, Toshimitsu Fujii, Shinichiro Shinzaki, Yohei Mikami, Shoko Arai, Junichi Oshima, Yutaka Endo, Hirotoshi Yuasa, Masato Hoshi, Keiko Sato, Tadakazu Hisamatsu
Journal of Gastroenterology.2025;[Epub] CrossRef
Efficacy and safety of filgotinib for ulcerative colitis: A real‐world multicenter retrospective study in Japan
Shintaro Akiyama, Kaoru Yokoyama, Soichi Yagi, Shinichiro Shinzaki, Kozo Tsuruta, Shinichiro Yoshioka, Minako Sako, Hiromichi Shimizu, Mariko Kobayashi, Toshiyuki Sakurai, Kei Nomura, Tomoyoshi Shibuya, Masahiro Takahara, Sakiko Hiraoka, Kyohei Sugai, Shu
Alimentary Pharmacology & Therapeutics.2024; 59(11): 1413. CrossRef
Real-World Data on the Effectiveness and Safety of Filgotinib for Ulcerative Colitis in Japanese Patients: A Single-Center Experience
Takahito Toba, Ryo Karashima, Kodai Fujii, Keiichi Inoue, Nanako Inoue, Yurie Ogawa, Aya Hojo, Ai Fujimoto, Takahisa Matsuda
Cureus.2024;[Epub] CrossRef
Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
BMC Gastroenterology.2024;[Epub] CrossRef
Patients’ Preference on Advanced Therapy and Follow-Up Procedure for Inflammatory Bowel Disease in Japan: A Web-Based 3A Survey
Toshifumi Morishita, Shunichi Yanai, Yosuke Toya, Takayuki Matsumoto
Inflammatory Intestinal Diseases.2024; 9(1): 174. CrossRef
The role and prospect of tofacitinib in patients with ulcerative colitis
Jun Lee
Intestinal Research.2023; 21(1): 168. CrossRef
Advances in pharmacotherapy for ulcerative colitis: a focus on JAK1 inhibitors
Alexander Goetsch, Ferdinando D’Amico, Mariangela Allocca, Gionata Fiorino, Federica Furfaro, Alessandra Zilli, Tommaso Lorenzo Parigi, Simona Radice, Laurent Peyrin-Biroulet, Silvio Danese
Expert Opinion on Pharmacotherapy.2023; 24(7): 849. CrossRef
Understanding the efficacy of individual Janus kinase inhibitors in the treatment of ulcerative colitis for future positioning in inflammatory bowel disease treatment
Hiroshi Nakase
Immunological Medicine.2023; 46(3): 121. CrossRef
Inflammation-Driven Colorectal Cancer Associated with Colitis: From Pathogenesis to Changing Therapy
Olga Maria Nardone, Irene Zammarchi, Giovanni Santacroce, Subrata Ghosh, Marietta Iacucci
Cancers.2023; 15(8): 2389. CrossRef
Extraintestinal Cancers in Inflammatory Bowel Disease: A Literature Review
Alessandro Massano, Luisa Bertin, Fabiana Zingone, Andrea Buda, Pierfrancesco Visaggi, Lorenzo Bertani, Nicola de Bortoli, Matteo Fassan, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Cristina Bezzio, Valentina Casini, Davide Giuseppe Ribaldone, Edoardo
Cancers.2023; 15(15): 3824. CrossRef
Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE
Stefan Schreiber, Gerhard Rogler, Mamoru Watanabe, Séverine Vermeire, Christian Maaser, Silvio Danese, Margaux Faes, Paul Van Hoek, Jeremy Hsieh, Ulrik Moerch, Yan Zhou, Angela de Haas, Christine Rudolph, Alessandra Oortwijn, Edward V. Loftus
Alimentary Pharmacology & Therapeutics.2023; 58(9): 874. CrossRef
Recent advances in anti-inflammatory active components and action mechanisms of natural medicines
Zhimin Wu, Tao Zhang, Xiaofei Ma, Shuai Guo, Qingqing Zhou, Arshad Zahoor, Ganzhen Deng
Inflammopharmacology.2023; 31(6): 2901. CrossRef
Filgotinib for moderately to severely active ulcerative colitis
Alessandro Mannucci, Ferdinando D’Amico, Ahmad El Saadi, Laurent Peyrin-Biroulet, Silvio Danese
Expert Review of Gastroenterology & Hepatology.2022; 16(10): 927. CrossRef

8,159 View
808 Download
13 Web of Science
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