Efficacy and safety of filgotinib for ulcerative colitis : A real-world multicenter retrospective study in Japan
© 2024 John Wiley & Sons Ltd..
BACKGROUND AND AIMS: While filgotinib, an oral Janus kinase (JAK) 1 preferential inhibitor, is approved for moderately to severely active ulcerative colitis (UC), real-world studies assessing its short- and long-term efficacy and safety are limited.
METHODS: This is a multicenter, retrospective study of UC patients who started filgotinib between March 2022 and September 2023. The primary outcome was clinical remission, defined as a partial Mayo score ≤1 with a rectal bleeding score of 0, or Simple Clinical Colitis Activity Index (SCCAI) ≤2 with a blood-in-stool score of 0. Secondary outcomes included clinical response, corticosteroid-free remission, and endoscopic improvement. Outcomes were assessed at 10, 26, and 58 weeks based on patients with available follow-up. Adverse events were evaluated.
RESULTS: We identified 238 UC patients and 54% had prior exposure to biologics/JAK inhibitors. The median baseline partial Mayo score and SCCAI were 5 (IQR 3-6) and 4 (IQR 2-7). Clinical remission rates based on per-protocol analysis at 10, 26, and 58 weeks were 47% (70/149), 55.8% (48/86), and 64.6% (31/48), respectively. At a median follow-up of 28 weeks (IQR 10-54) with a discontinuation rate of 39%, the rates of clinical remission, clinical response, corticosteroid-free remission, and endoscopic improvement were 39.9% (81/203), 54.7% (111/203), and 36.5% (74/203), and 43.5% (10/23), respectively. These rates were comparable between biologic/JAK inhibitor-naïve and -experienced patients. While three patients (1.3%) developed herpes zoster infection, no cases of thrombosis or death were reported.
CONCLUSIONS: Real-world data demonstrate favourable clinical and safety outcomes of filgotinib for UC.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - (2024) vom: 17. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Akiyama, Shintaro [VerfasserIn] |
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Date Revised 18.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1111/apt.17961 |
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| PPN (Katalog-ID): |
NLM369845528 |
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| 100 | 1 | |a Akiyama, Shintaro |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of filgotinib for ulcerative colitis |b A real-world multicenter retrospective study in Japan |
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| 520 | |a © 2024 John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND AND AIMS: While filgotinib, an oral Janus kinase (JAK) 1 preferential inhibitor, is approved for moderately to severely active ulcerative colitis (UC), real-world studies assessing its short- and long-term efficacy and safety are limited | ||
| 520 | |a METHODS: This is a multicenter, retrospective study of UC patients who started filgotinib between March 2022 and September 2023. The primary outcome was clinical remission, defined as a partial Mayo score ≤1 with a rectal bleeding score of 0, or Simple Clinical Colitis Activity Index (SCCAI) ≤2 with a blood-in-stool score of 0. Secondary outcomes included clinical response, corticosteroid-free remission, and endoscopic improvement. Outcomes were assessed at 10, 26, and 58 weeks based on patients with available follow-up. Adverse events were evaluated | ||
| 520 | |a RESULTS: We identified 238 UC patients and 54% had prior exposure to biologics/JAK inhibitors. The median baseline partial Mayo score and SCCAI were 5 (IQR 3-6) and 4 (IQR 2-7). Clinical remission rates based on per-protocol analysis at 10, 26, and 58 weeks were 47% (70/149), 55.8% (48/86), and 64.6% (31/48), respectively. At a median follow-up of 28 weeks (IQR 10-54) with a discontinuation rate of 39%, the rates of clinical remission, clinical response, corticosteroid-free remission, and endoscopic improvement were 39.9% (81/203), 54.7% (111/203), and 36.5% (74/203), and 43.5% (10/23), respectively. These rates were comparable between biologic/JAK inhibitor-naïve and -experienced patients. While three patients (1.3%) developed herpes zoster infection, no cases of thrombosis or death were reported | ||
| 520 | |a CONCLUSIONS: Real-world data demonstrate favourable clinical and safety outcomes of filgotinib for UC | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Yagi, Soichi |e verfasserin |4 aut | |
| 700 | 1 | |a Shinzaki, Shinichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuruta, Kozo |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshioka, Shinichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Sako, Minako |e verfasserin |4 aut | |
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