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^{1

2}, Richard Fernandes^{1

2}, Imogen Hartley³, Arteen Arzivian⁴, Rupert Leong⁴, Bridgette Andrew⁵, Abhinav Vasudevan^{5

6}, Tessa Greeve⁷, Gregory Thomas Moore^{7

8}, Steven Kim⁹, Daniel Lightowler^{10

11}, Abhey Singh^{9

10}, Gillian Mahy¹², Aditya Mithanthaya¹³, Kannan Venugopaul¹³, Sangwoo Han¹⁴, Robert Bryant¹⁴, Jack West¹⁵, Jonathan Segal^{15

16}, Britt Christensen^{15

16}, Crispin Corte^{17

18}, Nik Ding³, Yoon-Kyo An^{1

2}, Jakob Begun^{1

2}

Affiliations

¹ Department of Gastroenterology, Mater Hospital, Brisbane, Australia.
² Mater Research Institute, The University of Queensland, South Brisbane, Australia.
³ Department of Gastroenterology, St. Vincent's Hospital, Melbourne, Australia.
⁴ Department of Gastroenterology, Macquarie University Hospital, Sydney, Australia.
⁵ Department of Gastroenterology, Eastern Health, Melbourne, Australia.
⁶ Monash University, Eastern Health Clinical School, Melbourne, Australia.
⁷ Department of Gastroenterology, Monash Health, Melbourne, Australia.
⁸ Department of Medicine, Monash University, Melbourne, Australia.
⁹ Department of Gastroenterology, Fiona Stanley Hospital, Perth, Australia.
¹⁰ Wexford Gastroenterology, Perth, Australia.
¹¹ Medical School, The University of Western Australia, Perth, Australia.
¹² Department of Gastroenterology, Townsville University Hospital, Townsville, Australia.
¹³ Department of Gastroenterology, Royal Perth Hospital, Perth, Australia.
¹⁴ Department of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, Australia.
¹⁵ Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Australia.
¹⁶ Department of Medicine, University of Melbourne, Melbourne, Australia.
¹⁷ AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, Australia.
¹⁸ Faculty of Medicine and Health, University of Sydney, Australia.

PMID: 39709985
PMCID: PMC12332279
DOI: 10.5217/ir.2024.00127

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 et al. Intest Res. 2025 Jul.

. 2025 Jul;23(3):347-357.

doi: 10.5217/ir.2024.00127. Epub 2024 Dec 20.

Authors

Affiliations

¹ Department of Gastroenterology, Mater Hospital, Brisbane, Australia.
² Mater Research Institute, The University of Queensland, South Brisbane, Australia.
³ Department of Gastroenterology, St. Vincent's Hospital, Melbourne, Australia.
⁴ Department of Gastroenterology, Macquarie University Hospital, Sydney, Australia.
⁵ Department of Gastroenterology, Eastern Health, Melbourne, Australia.
⁶ Monash University, Eastern Health Clinical School, Melbourne, Australia.
⁷ Department of Gastroenterology, Monash Health, Melbourne, Australia.
⁸ Department of Medicine, Monash University, Melbourne, Australia.
⁹ Department of Gastroenterology, Fiona Stanley Hospital, Perth, Australia.
¹⁰ Wexford Gastroenterology, Perth, Australia.
¹¹ Medical School, The University of Western Australia, Perth, Australia.
¹² Department of Gastroenterology, Townsville University Hospital, Townsville, Australia.
¹³ Department of Gastroenterology, Royal Perth Hospital, Perth, Australia.
¹⁴ Department of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, Australia.
¹⁵ Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Australia.
¹⁶ Department of Medicine, University of Melbourne, Melbourne, Australia.
¹⁷ AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, Australia.
¹⁸ Faculty of Medicine and Health, University of Sydney, Australia.

PMID: 39709985
PMCID: PMC12332279
DOI: 10.5217/ir.2024.00127

Abstract

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.

Keywords: Intestinal ultrasound; Janus kinase inhibitors; Tofacitinib; Ulcerative colitis; Upadacitinib.

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Conflict of interest statement

Conflict of Interest

An YK reports grants from Janssen, during the conduct of the study; has received speaking and consulting fees from AbbVie, Bristol Myers Squibb, Celltrion, Chiesi, Dr Falk, Ferring, Janssen, Pfizer, Sandoz, Shire and Takeda; served on advisory boards member for AbbVie, Bristol Myers Squibb, Chiesi, Janssen, NPS Medicine wise; received research and educational funding from AbbVie, Celltrion, Dr Falk, Janssen, Pfizer, Sandoz and Takeda. Begun J has received speaking and consulting fees from AbbVie, Bristol Myers Squibb, Celltrion, Chiesi, Dr Falk, Ferring, Janssen, Pfizer, Sandoz, Shire, and Takeda; served on advisory boards member for AbbVie, Takeda, Ferring, Celltrion, Bristol Myers Squibb, Chiesi, Janssen, NPS Medicine wise, Anatara, Microba; received research and educational funding from AbbVie, Janssen, Pfizer, Ferring and Takeda. Segal J has received speaker fees for Takeda, Pfizer, Sandoz, BMS, Dr Falk. He has received conference fees from BMS, Takeda and Pfizer. Leong R reports advisory board membership, speakers fees or research grants with AbbVie, Aspen, Ferring, Hospira/Pfizer, Janssen, Takeda, Shire, Celgene, Dr Falk Pharma, Novartis, MSD, Chiesi, BMS, Glutagen, Celltrion, McKusker Charitable Foundation, Joanna Tiddy University of Sydney grant, MRFF, NHMRC. Lightowler D reports advisory board membership, speaker fees or research grants with AbbVie, Janssen, Eli-Lilly, Pfizer. Singh A has received speaker or consultancy fees from AbbVie, Takeda, Janssen, Pfizer and Dr Falk Pharma. Moore GT has received speaker or consultancy fees or advisory board fees for AbbVie, BMS, Celgene, Celltrion, Chiesi, Dr Falk Pharma, Eli-Lilly, Ferring, Janssen, MSD, Pfizer, Takeda and research support from CCA, The Gutsy Group and MRFF. Bryant R has received grant/research support/speaker fees from AbbVie, Ferring, Janssen, BMS, Shire, Takeda, Dr Falk Pharma, GSK and Emerge Health; and is a shareholder in Biomebank. Corte C has received grant/research support/speaker fees from Janssen, AbbVie, Chiesi, Takeda, Ferring, Falk and GESA.

Leong R is an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

Figures

**Fig. 1.**
Clinical remission at baseline, week 8 and week 16.

**Fig. 2.**
Clinical response at week 8 and week 16.

**Fig. 3.**
Clinical remission at baseline, week 8, and week 16 stratified by prior tofacitinib exposure.

**Fig. 4.**
Clinical remission at week 8 and week 16 stratified by prior tofacitinib exposure in those with active disease at baseline.

See this image and copyright information in PMC

Comment in

Upadacitinib after tofacitinib in ulcerative colitis.
Cho HJ, Kim ES. Cho HJ, et al. Intest Res. 2025 Jul;23(3):229-230. doi: 10.5217/ir.2025.00114. Epub 2025 Jul 29. Intest Res. 2025. PMID: 40764875 Free PMC article. No abstract available.

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Upadacitinib induction is effective and safe in ulcerative colitis patients including those with prior exposure to tofacitinib: a multicenter real-world cohort study

Affiliations

Upadacitinib induction is effective and safe in ulcerative colitis patients including those with prior exposure to tofacitinib: a multicenter real-world cohort study

Authors

Affiliations

Abstract

Conflict of interest statement

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Comment in

References

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