Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial

• Published in: Intestinal research 2023, 21(1), , pp.110-125
• Main Authors: Hibi, Toshifumi, Motoya, Satoshi, Hisamatsu, Tadakazu, Hirai, Fumihito, Watanabe, Kenji, Matsuoka, Katsuyoshi, Saruta, Masayuki, Kobayashi, Taku, Feagan, Brian G, Tasset, Chantal, Besuyen, Robin, Yun, Chohee, Crans, Gerald, Zhang, Jie, Kondo, Akira, Watanabe, Mamoru
• Format: Article
• Language: English
• Subjects: colitis, ulcerative; filgotinib; janus kinase inhibitors; japan; Original; 내과학
• ISSN: 1598-9100; 2288-1956
• DOI: 10.5217/ir.2021.00143

Background/Aims: The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.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.