Tanaka Yoshiya, Matsubara Tsukasa, Atsumi Tatsuya, Amano Koichi, Ishiguro Naoki, Hirata Shintaro, Yamaoka Kunihiro, Combe Bernard G, Nash Peter, Genovese Mark, Pechonkina Alena, Liu Jie, Kondo Akira, Fukada Haruhiko, De Leonardis Francesco, Takeuchi Tsutomu
First Department of Internal Medicine, University of Occupational and Environmental Health, Fukuoka, Japan.
Department of Orthopedics, Matsubara Mayflower Hospital, Hyogo, Japan.
Mod Rheumatol. 2025 Apr 8;35(3):425-433. doi: 10.1093/mr/roae099.
The aim of this article is to describe the safety and efficacy of filgotinib 200 mg (FIL200) or FIL 100 mg (FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (NCT03025308).
Patients who completed any of three parent studies (NCT02889796: inadequate response to methotrexate; NCT02873936: inadequate response to biologic disease-modifying antirheumatic drugs; NCT02886728: methotrexate-naïve) without rescue therapy could enter the long-term extension; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes Week 156 interim results.
Among Japanese patients, 110 received FIL200, and 97 received FIL100. Mean (SD) FIL200 and FIL100 exposure was 157.0 (51.49) and 156.0 (52.45) weeks. The exposure-adjusted incidence rates (95% confidence interval) for FIL200/FIL100 were 2.7 (1.4, 5.2)/2.4 (1.2, 5.1) for herpes zoster, 0.9 (0.3, 2.8)/1.0 (0.3, 3.2) for malignancy (excluding nonmelanoma skin cancer), and 0.6 (0.2, 2.4)/0.3 (0.0, 2.4) for major adverse cardiovascular events. More patients receiving FIL200 with prior FIL200 exposure achieved clinical remission vs other groups (including Clinical Disease Activity Index remission in 40% vs ≤27% at Week 156).
FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.
本文旨在描述非戈替尼200毫克（FIL200）或非戈替尼100毫克（FIL100）在日本类风湿性关节炎患者长期扩展研究（NCT03025308）中的安全性和有效性。
完成三项母研究（NCT02889796：对甲氨蝶呤反应不足；NCT02873936：对生物性改善病情抗风湿药反应不足；NCT02886728：未使用过甲氨蝶呤）中任何一项且未接受挽救治疗的患者可进入长期扩展研究；服用非戈替尼的患者继续其剂量，接受对照药物的患者重新随机分组至FIL200或FIL100。本分析纳入了第156周的中期结果。
在日本患者中，110例接受FIL200，97例接受FIL100。FIL200和FIL100的平均（标准差）暴露时间分别为157.0（51.49）周和156.0（52.45）周。FIL200/FIL100的暴露调整发病率（95%置信区间）分别为：带状疱疹为2.7（1.4，5.2）/2.4（1.2，5.1），恶性肿瘤（不包括非黑色素瘤皮肤癌）为0.9（0.3，2.8）/1.0（0.3，3.2），主要不良心血管事件为0.6（0.2，2.4）/0.3（0.0，2.4）。与其他组相比，更多先前接受过FIL200暴露的患者接受FIL200后实现了临床缓解（包括在第156周时临床疾病活动指数缓解率为40%，而其他组≤27%）。
FIL200和FIL100在日本患者中总体耐受性良好，未出现新的、意外的不良事件。
