Intestinal Research

Original Articles

IBD

Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn’s disease: Robert Gilmore, Amrutha Murali, Amirah Etchegaray, Ei Swe, Yoon-Kyo An, Jakob Begun; Intest Res 2025;23(4):475-482. Published online June 9, 2025; DOI: https://doi.org/10.5217/ir.2024.00174

Background/Aims
Inflammatory bowel disease (IBD) is characterised by chronic inflammation of the gastrointestinal tract, and encompasses both ulcerative colitis (UC) and Crohn’s disease (CD). Refractory disease is common, a combination of advanced drug therapies may be required to obtain maximal efficacy. We describe the use of upadacitinib therapy in combination with vedolizumab therapy for the management of refractory UC and CD.
Methods
In this retrospective observational study, patients who received upadacitinib in combination with vedolizumab were identified at a tertiary IBD center between November 2022 and March 2024. Patients were followed for 6 months with clinical, biochemical, endoscopic and intestinal ultrasound outcomes.
Results
Sixteen patients (7 with UC, 9 with CD) were identified. Median age was 44 years (range, 25–58 years), 11 (69%) were male, and median number of prior biologic exposures was 3 (range, 2–5). Twelve patients (75%) achieved clinical response, clinical remission, biochemical remission, corticosteroid-free clinical remission, and transmural remission by intestinal ultrasound. Eleven patients (69%) achieved endoscopic remission, with 4 (25%) achieving histological remission. Adverse events were seen in 8 patients (50%), but the majority were mild and did not require interruption of therapy.
Conclusions
Upadacitinib in combination with vedolizumab may have a role in refractory UC and CD patients who have previously failed to respond to standard therapy, with a favorable safety profile. Prospective studies are required to determine the safety and efficacy of this combination in larger cohorts before routine use can be recommended.

Citations

Citations to this article as recorded by

Efficacy and Safety of Vedolizumab and Tofacitinib (VETO) Combination Therapy in Refractory Ulcerative Colitis Unresponsive to Anti‐TNF and a Second‐Line Advanced Therapy: A Prospective Cohort Nested Within a Randomised Trial
Pardhu Bharath Neelam, Dhanush Mekala, Rajender Patel, Rupa Banerjee
Alimentary Pharmacology & Therapeutics.2026; 63(1): 81. CrossRef
Advances in Crohn's Disease: A Comprehensive Review of Pathophysiology, Diagnosis, and Emerging Therapeutics
Yoon‐Kyo An, Robert Gilmore, Graham Radford‐Smith, Jakob Begun
JGH Open.2026;[Epub] CrossRef
Application of intestinal ultrasound in monitoring and evaluation of ulcerative colitis
Jia-Xian Pei, Ye Zhao
World Chinese Journal of Digestology.2026; 34(3): 258. CrossRef
Advanced Combination Therapy in Inflammatory Bowel Disease
So Jung Han, Jae Hee Cheon
The Korean Journal of Gastroenterology.2026; 86(2): 85. CrossRef
Inflammatory Bowel Disease: Understanding Therapeutic Effects of Distinct Molecular Inhibitors as the Key to Current and Future Advanced Therapeutic Strategies
Alice Laffusa, Cesare Burti, Chiara Viganò, Francesca Poggi, Laura Grieco, Vincenzo Occhipinti, Salvatore Greco, Stefania Orlando
Biomedicines.2025; 13(11): 2667. CrossRef
Synergistic effects of vedolizumab and JAK 1,2,3 inhibitors in Crohn’s disease: insights from a systems biology and artificial intelligence-based approach
Ignacio Marín-Jiménez, Mónica Sierra-Ausín, Teresa Letosa-Abián, Jesús Aparicio, Carmen Montoto-Otero, Silvia Sánchez-Ramón
Frontiers in Immunology.2025;[Epub] CrossRef

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IBD

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; Intest Res 2025;23(3):347-357. Published online December 20, 2024; DOI: https://doi.org/10.5217/ir.2024.00127

Abstract PDF PubReader ePub

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

Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective
Shintaro Akiyama
Intestinal Research.2026; 24(2): 197. CrossRef
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
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
Oral Colon-Targeted Lipid Nanoparticles Enhance Upadacitinib Delivery and Efficacy in a Murine Model of Ulcerative Colitis
Rabeya Jafrin Mow, Xiaodi Shi, Wen Lu, Siming Wang, Didier Merlin, Chunhua Yang
International Journal of Molecular Sciences.2026; 27(9): 3758. CrossRef
Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines on the Use of Small Molecules and IL‐23 p19 Inhibitors in Ulcerative Colitis and Crohn's Disease
Choon Jin Ooi, Khoon Lin Ling, Julajak Limsrivilai, Shu‐Chen Wei, Joyce Wing Yan Mak, Taku Kobayashi, Luan Minh Dang, Rupert W. Leong, Huiyu Lin, Meng‐Tzu Weng, Wan Chee Ong, Vineet Ahuja, Satimai Aniwan, Ryota Hokari, Wei Jie Jonathan Lee, Alex Hwong‐Rue
Journal of Gastroenterology and Hepatology.2026;[Epub] CrossRef
Letter: Toward Intra‐Class Switching With JAK Inhibitors?
Mathieu Uzzan, David Laharie
Alimentary Pharmacology & Therapeutics.2025; 61(5): 919. CrossRef
Effectiveness and Safety of a Second JAK Inhibitor in Ulcerative Colitis: The J2J Multicentre Study
Mathilde Osty, Romain Altwegg, Mélanie Serrero, Alban Benezech, Albane Lecomte, Guillaume Cadiot, Lucine Vuitton, Anne Wampach, Stéphane Nancey, Anthony Buisson, Catherine le Berre, Clea Rouillon, Cyrielle Gilletta, Felix Goutorbe, Mathurin Fumery, Nassim
Alimentary Pharmacology & Therapeutics.2025; 62(4): 430. CrossRef
Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn’s disease
Robert Gilmore, Amrutha Murali, Amirah Etchegaray, Ei Swe, Yoon-Kyo An, Jakob Begun
Intestinal Research.2025; 23(4): 475. CrossRef
Upadacitinib after tofacitinib in ulcerative colitis
Hyeon Jin Cho, Eun Soo Kim
Intestinal Research.2025; 23(3): 229. CrossRef
A Comparison of the Efficacy and Safety of Ustekinumab and Upadacitinib in Biologically Experienced Ulcerative Colitis Patients
Osman Özdoğan, Serkan Yaraş, Mehmet Kasım Aydın, Fehmi Ateş, Engin Altıntaş, Orhan Sezgin
Biomedicines.2025; 13(10): 2455. CrossRef
Is 2nd JAKi treatment for UC worth the effort? A retrospective, multi-centre UK study
Chandni Radia, Yaa Danso, Susan Ritchie, Melissa Hale, Alexander T Elford, Chirag Patel, Lucy Hicks, Sonia Kalyanji, Chaonan Dong, Katie Yeung, Jie Han Yeo, Mohammed Allah-Ditta, Maria Bishara, Karishma Sethi-Arora, Lushen Pillay, Emma L Johnston, Ruth Ru
Journal of Crohn's and Colitis.2025;[Epub] CrossRef
IBD 2024: Charting a New Course in IBD Proceedings of the Takeda Symposium 22–23 November 2024 W Hotel, Brisbane, Queensland, Australia
Uma Mahadevan, Vipul Jairath, Jakob Begun, Aviv Pudipeddi, Mayur Garg, Peter De Cruz, Christopher F. D. Li Wai Suen, Matthew C. Choy, Danny Con, Rose Vaughan, John D. Chetwood, David A. Clark, Craig Haifer, Miles P. Sparrow, Rupert Leong, Réme Mountifield
Journal of Gastroenterology and Hepatology.2025; 40(S3): 3. CrossRef
Three Janus kinase inhibitors in ulcerative colitis: is upadacitinib taking the lead?
Yoon Suk Jung
Intestinal Research.2025; 23(4): 394. CrossRef
Upadacitinib’s Effectiveness and Safety as a Second- or Third-Line Therapy in Patients with Ulcerative Colitis: Data from a Real-World Study
Giammarco Mocci, Antonio Tursi, Franco Scaldaferri, Daniele Napolitano, Daniela Pugliese, Giovanni Maconi, Giovanni Cataletti, Roberta Pica, Claudio Cassieri, Edoardo Vincenzo Savarino, Caterina De Barba, Francesco Costa, Linda Ceccarelli, Manuela Marzo,
Journal of Clinical Medicine.2025; 14(21): 7801. CrossRef

9,449 View
433 Download
13 Web of Science
14 Crossref

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