Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4.

IF 1.8 4区医学 Q3 RHEUMATOLOGY Modern Rheumatology Pub Date : 2024-11-07 DOI:10.1093/mr/roae099

Yoshiya Tanaka, Tsukasa Matsubara, Tatsuya Atsumi, Koichi Amano, Naoki Ishiguro, Shintaro Hirata, Kunihiro Yamaoka, Bernard G Combe, Peter Nash, Mark Genovese, Alena Pechonkina, Jie Liu, Akira Kondo, Haruhiko Fukada, Francesco De Leonardis, Tsutomu Takeuchi

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Abstract

Objectives: To describe safety and efficacy of filgotinib 200 or 100 mg (FIL200/FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (LTE; NCT03025308).

Methods: Patients who completed any of three parent studies (NCT02889796: inadequate response [IR] to methotrexate [MTX]; NCT02873936: IR to biologic disease-modifying antirheumatic drugs; NCT02886728: MTX-naïve) without rescue therapy could enter the LTE; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes week 156 interim results.

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% CI) 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% or less at week 156).

Conclusions: FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.

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日本类风湿关节炎患者服用非戈替尼的安全性和有效性：FINCH 4第156周中期结果。

目的：在一项长期扩展研究（LTE；NCT03025308）中描述日本类风湿性关节炎患者服用菲戈替尼200或100毫克（FIL200/FIL100）的安全性和有效性：方法：完成三项母研究（NCT02889796：对甲氨蝶呤[MTX]反应不充分[IR]；NCT02873936：对生物制剂改变病情反应不充分[IR]）中任何一项研究的患者：对生物改变病情抗风湿药反应不充分的患者；NCT02886728：MTX无效的患者）未接受抢救治疗的患者可参加LTE；服用FIL的患者继续服用，接受比较药的患者被重新随机分配到FIL200或FIL100。本分析包括第156周的中期结果：在日本患者中，110 人接受了 FIL200 治疗，97 人接受了 FIL100 治疗。FIL200和FIL100的平均（标清）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% CI）分别为：带状疱疹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）0.9（0.3，2.8）/1.0（0.3，3.2）；主要不良心血管事件0.6（0.2，2.4）/0.3（0.0，2.4）。与其他组别相比，更多接受FIL200治疗并曾接触过FIL200的患者实现了临床缓解（包括在第156周时，40%的患者实现了临床疾病活动指数缓解，而27%或更少）：结论：日本患者对 FIL200 和 FIL100 的耐受性普遍良好，没有出现新的意外不良事件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Modern Rheumatology RHEUMATOLOGY-

CiteScore

4.90

自引率

9.10%

发文量

146

审稿时长

1.5 months

期刊介绍： Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery. Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered. Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions