In which patients with ulcerative colitis would filgotinib be effective?

Jihye Park

doi:10.5217/ir.2024.00171

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Editorial IBD In which patients with ulcerative colitis would filgotinib be effective?: Jihye Park^,; Intestinal Research 2025;23(1):1-2.
DOI: https://doi.org/10.5217/ir.2024.00171
Published online: January 24, 2025

Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea

Correspondence to Jihye Park, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. E-mail: wisdompark@yuhs.ac

• Received: October 18, 2024 • Accepted: December 26, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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REFERENCES

See the article "Filgotinib induction-study baseline characteristics of patients with ulcerative colitis who achieve sustained corticosteroid-free remission: post hoc analysis of the phase 2b/3 SELECTION study" on page 65.

Inflammatory bowel disease is chronic recurrent inflammation of the gastrointestinal tract, and requires lifelong medical treatment such as 5-aminosalicylates, corticosteroids, immunomodulators, biologic agents, and small molecules. Janus kinase (JAK) inhibitors, a family of small molecules that block one or more of the intracellular tyrosine kinases, are currently approved as a novel group of orally administered drugs by attenuating multiple cytokine signaling pathways to mediate dysregulated immune responses [1]. There are 3 JAK inhibitors approved for patients with moderate to severe ulcerative colitis (UC): tofacitinib (a non-selective JAK inhibitor), filgotinib (selective JAK-1 inhibitor), and upadacitinib (selective JAK-1 inhibitor) [2].

Filgotinib, an oral JAK-1 inhibitor, received its approvals for UC in the European Medicines Agency in 2020, Japanese Ministry of Health in 2022, and South Korea in 2024. Filgotinib selectively inhibits JAK1 over JAK2, JAK3, and tyrosine kinase 2, and could have different effectiveness and safety profiles compared to previous JAK inhibitors [3]. In the phase 2b/3 SELECTION trial, the efficacy and safety of filgotinib in inducing and maintaining remission in patients with moderately to severely active UC were investigated from 341 study centers in 40 countries [4]. Filgotinib has a rapid mechanism of action, oral administration drug, and innovative drug for patients with corticosteroid-resistant and corticosteroid-dependent UC. However, there is no algorithm or randomized controlled trials that positions this drug over currently approved drugs for moderate to severe UC patients [5]. Therefore, the predictive factors associated the good clinical outcomes could be useful in decision-making and personalize healthcare clinical practice [6].

Corticosteroid-free remission is an important treatment target in UC patients, and the corticosteroid-sparing effects of filgotinib was investigated in the previous post hoc analyses of the SELECTION study [7]. Corticosteroid-free remission rate in patients receiving filgotinib was 30.4%, 29.3%, 27.2%, and 21.7% at 1, 3, 6, and 8 months, respectively. During the maintenance study, the median daily prednisone-equivalent dose decreased from 17.5 mg/day to 10.0 mg/day with filgotinib treatment.

In the current issue, Kobayashi et al. [8] investigated the independent prognostic factors of achieving corticosteroid-free remission in patients of UC treated with filgotinib by post hoc analysis of the phase 2b/3 SELECTION study. This article suggested that corticosteroid-free remission was higher in patients who were biologic-naïve, current smokers, had low endoscopic inflammatory burden and who were female.

NOTES

Funding Source

The author received no financial support for the research, authorship, and/or publication of this article.

Conflict of Interest

Park J 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.

Data Availability Statement

Not applicable.

Author Contributions

Writing and approval of the final manuscript: Park J.

REFERENCES

1. Honap S, Agorogianni A, Colwill MJ, et al. JAK inhibitors for inflammatory bowel disease: recent advances. Frontline Gastroenterol 2023;15:59–69.Article PubMed PMC
2. Shimizu H, Aonuma Y, Hibiya S, et al. Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study. Intest Res 2024;22:369–377.Article PubMed PMC PDF
3. Dowty ME, Lin TH, Jesson MI, et al. Janus kinase inhibitors for the treatment of rheumatoid arthritis demonstrate similar profiles of in vitro cytokine receptor inhibition. Pharmacol Res Perspect 2019;7:e00537.Article PubMed PMC PDF
4. Feagan BG, Danese S, Loftus EV Jr, et al. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet 2021;397:2372–2384.Article PubMed
5. D’Amico F, Magro F, Peyrin-Biroulet L, Danese S. Positioning filgotinib in the treatment algorithm of moderate to severe ulcerative colitis. J Crohns Colitis 2022;16:835–844.Article PubMed PMC PDF
6. Ananthakrishnan AN. Precision medicine in inflammatory bowel diseases. Intest Res 2024;22:8–14.Article PubMed PMC PDF
7. Loftus EV, Vermeire S, Feagan BG, et al. Corticosteroid-sparing effects of filgotinib in moderately to severely active ulcerative colitis: data from the phase 2b/3 SELECTION study. J Crohns Colitis 2023;17:211–220.Article PubMed PMC PDF
8. Kobayashi T, Dignass A, Roblin X, et al. Filgotinib inductionstudy baseline characteristics of patients with ulcerative colitis who achieve sustained corticosteroid-free remission: post hoc analysis of the phase 2b/3 SELECTION study. Intest Res 2025;23:65–75.Article PubMed PDF

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