在日本初治甲氨蝶呤（MTX）的类风湿关节炎患者中，非戈替尼治疗的长期安全性和有效性（FINCH 3）
Long-term safety and efficacy of filgotinib treatment for rheumatoid arthritis in Japanese patients naïve to MTX treatment (FINCH 3).
作者信息
Atsumi Tatsuya, Tanaka Yoshiya, Matsubara Tsukasa, Amano Koichi, Ishiguro Naoki, Sugiyama Eiji, Yamaoka Kunihiro, Westhovens René, Ching Daniel W T, Messina Osvaldo Daniel, Burmester Gerd R, Genovese Mark, Bartok Beatrix, Pechonkina Alena, Kondo Akira, Yin Zhaoyu, Gong Qi, Tasset Chantal, Takeuchi Tsutomu
机构信息
Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Hokkaido, Japan.
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
出版信息
Mod Rheumatol. 2023 Jul 4;33(4):657-667. doi: 10.1093/mr/roac083.
OBJECTIVES
To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim long-term extension (LTE) to Week 48 through June 2020.
METHODS
Patients were randomised to FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, or MTX for 52 weeks. At completion, eligible patients could enrol in the LTE. Those receiving FIL continued; those receiving MTX were rerandomised (blinded) to FIL 200 or 100 mg upon discontinuation of MTX. After a 4-week washout period, MTX could be re-added.
RESULTS
Adverse event rates at Week 52 and in the LTE to Week 48 were comparable across treatment groups. Week 52 American College of Rheumatology 20% improvement (ACR20) rates were 83% (19/23), 82% (9/11), 75% (9/12), and 76% (19/25) for FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, and MTX, respectively. Through LTE Week 48, ACR20 rates were maintained.
CONCLUSIONS
In the 56 Japanese patients treated with FIL, efficacy was maintained through Week 52 and beyond, with no increases in the incidence of adverse events.
目的
评估非戈替尼（FIL）对日本类风湿关节炎（RA）患者且既往甲氨蝶呤（MTX）暴露有限/无暴露的长期安全性和有效性。我们展示了一项全球随机对照试验在第52周时对日本人群的亚组分析以及截至2020年6月的第48周中期长期扩展（LTE）分析。
方法
患者被随机分为接受FIL 200mg加MTX、FIL 100mg加MTX、FIL 200mg或MTX治疗52周。完成治疗后，符合条件的患者可进入LTE。接受FIL治疗的患者继续用药；接受MTX治疗的患者在停用MTX后被重新随机（盲法）分为接受FIL 200mg或100mg治疗。经过4周的洗脱期后，可重新添加MTX。
结果
各治疗组在第52周和LTE至第48周时的不良事件发生率相当。第52周时，美国风湿病学会20%改善（ACR20）率在FIL 200mg加MTX组为83%（19/23），FIL 100mg加MTX组为82%（9/11），FIL 200mg组为75%（9/12），MTX组为76%（19/25）。至LTE第48周，ACR20率得以维持。
结论
在56例接受FIL治疗的日本患者中，疗效维持至第52周及以后，不良事件发生率未增加。
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