在对甲氨蝶呤反应不足的日本类风湿关节炎患者中，Filgotinib 的安全性和疗效：FINCH1 的 52 周结果和 FINCH4 的 48 周结果。
Safety and efficacy of filgotinib for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results.
机构信息
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Department of Orthopedics, Matsubara Mayflower Hospital, Kato, Hyogo, Japan.
出版信息
Mod Rheumatol. 2023 Jul 4;33(4):668-679. doi: 10.1093/mr/roac084.
OBJECTIVES
To present safety and efficacy of the JAK1 preferential inhibitor filgotinib in Japanese patients with prior inadequate response (IR) to methotrexate (MTX) from a 52-week randomised controlled parent study (PS) and long-term extension (LTE) through June 2020.
METHODS
The PS (NCT02889796) randomised MTX-IR patients to filgotinib 200 (FIL200) or 100 mg (FIL100), adalimumab (ADA) 40 mg, or placebo; all took stable background MTX. At week (W) 24, placebo patients were rerandomised to FIL200 or FIL100. The primary endpoint was W12 American College of Rheumatology 20% improvement; safety was assessed by adverse event (AE) reporting. For the LTE (NCT03025308), eligible filgotinib patients continued FIL200/FIL100; ADA patients were rerandomised (blinded) to FIL200 or FIL100; all continued MTX.
RESULTS
In all, 114/147 Japanese patients completed the PS, 115 enrolled in LTE, and 103 remained on study in June 2020. In the PS, AEs were consistent with the overall population, and W24 efficacy was maintained or improved through W52, comparable with the overall population. LTE AE incidences were similar between doses; filgotinib efficacy was consistent from baseline to W48 and similar between PS ADA and filgotinib patients.
CONCLUSIONS
Among MTX-IR Japanese patients, filgotinib maintained efficacy over 1 year; LTE safety was consistent with the PS.
目的
介绍 JAK1 选择性抑制剂 filgotinib 在既往对甲氨蝶呤（MTX）治疗反应不足（IR）的日本患者中的安全性和疗效，该研究来自一项为期 52 周的随机对照研究（PS）和 2020 年 6 月之前的长期扩展（LTE）。
方法
PS（NCT02889796）将 MTX-IR 患者随机分为 filgotinib 200（FIL200）或 100mg（FIL100）、阿达木单抗（ADA）40mg 或安慰剂组；所有患者均接受稳定剂量的 MTX 治疗。在第 24 周，安慰剂患者重新随机分配至 FIL200 或 FIL100。主要终点为第 12 周美国风湿病学会 20%改善；安全性通过不良事件（AE）报告进行评估。对于 LTE（NCT03025308），符合条件的 filgotinib 患者继续接受 FIL200/FIL100；ADA 患者重新（盲法）随机分配至 FIL200 或 FIL100；所有患者继续接受 MTX 治疗。
结果
共有 114/147 例日本患者完成了 PS，115 例患者入组了 LTE，2020 年 6 月 103 例患者仍在接受研究。PS 中，AE 与总体人群一致，并且 W24 疗效在 W52 时得到维持或改善，与总体人群相当。两种剂量的 LTE AE 发生率相似；从基线到 W48，filgotinib 的疗效始终保持一致，并且与 PS 中 ADA 和 filgotinib 患者的疗效相似。
结论
在 MTX-IR 的日本患者中，filgotinib 在 1 年以上时间内保持疗效；LTE 的安全性与 PS 一致。
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