Abstract | BACKGROUND/AIMS: 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.
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Authors | 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 |
Journal | Intestinal research
(Intest Res)
Vol. 21
Issue 1
Pg. 110-125
(Jan 2023)
ISSN: 1598-9100 [Print] Korea (South) |
PMID | 35263963
(Publication Type: Journal Article)
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