Centre for Musculoskeletal Research, University of Manchester, Manchester, UK
NIHR Manchester Biomedical Research Centre, Manchester, UK.
RMD Open. 2024 Oct 24;10(4):e004476. doi: 10.1136/rmdopen-2024-004476.
Janus kinase inhibitors are an effective option for achieving sustained remission or low disease activity in patients with rheumatoid arthritis (RA) following inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs. Filgotinib is a Janus kinase 1-preferential inhibitor available in two doses for moderate-to-severe RA. We report the long-term efficacy and safety of filgotinib.
In the ongoing long-term extension study FINCH 4 (NCT03025308), patients continue filgotinib 200 mg or 100 mg from FINCH 1, 2 or 3 or receive filgotinib 200 mg or 100 mg de novo. Efficacy assessments up to week 156 include American College of Rheumatology 20% response (ACR20), Disease Activity Score 28 using C-reactive protein of <2.6, Clinical Disease Activity Index of ≤2.8, Simplified Disease Activity Index of ≤3.3 and Boolean remission (1.0 and 2.0) with non-responder imputation.
In patients with an inadequate response to methotrexate, 60.2% and 54.6% receiving de novo filgotinib 200 mg and 100 mg had an ACR20 at week 156, respectively, as did 67.3% and 59.5% of those who continued filgotinib 200 mg and 100 mg. At week 156, Boolean remission 1.0 was achieved by 18.8% and 15.4% of patients treated with de novo filgotinib 200 mg and 100 mg, respectively, and by 21.1% and 18.5% when Boolean 2.0 criteria were applied. Similar efficacy data were seen in patients from FINCH 2 and 3. Safety data were consistent with the known safety profile of filgotinib.
In FINCH 4, filgotinib 200 mg and 100 mg (continuous or de novo) demonstrated sustained efficacy up to week 156 in patients enrolled from FINCH 1, 2 or 3, with no unexpected safety results.
在对传统合成改善病情抗风湿药物反应不足的类风湿关节炎（RA）患者中，Janus 激酶抑制剂是实现持续缓解或低疾病活动度的有效选择。Filgotinib 是一种 Janus 激酶 1 优先抑制剂，有两种剂量适用于中重度 RA。我们报告了 filgotinib 的长期疗效和安全性。
在正在进行的长期扩展研究 FINCH 4（NCT03025308）中，患者继续从 FINCH 1、2 或 3 接受 filgotinib 200mg 或 100mg 或接受新的 filgotinib 200mg 或 100mg。在第 156 周之前，对疗效评估包括美国风湿病学会 20%反应（ACR20）、使用 C 反应蛋白的疾病活动评分 28 低于 2.6、临床疾病活动指数≤2.8、简化疾病活动指数≤3.3 和布尔缓解（1.0 和 2.0），并进行非应答者推断。
在对甲氨蝶呤反应不足的患者中，分别有 60.2%和 54.6%接受新的 filgotinib 200mg 和 100mg 的患者在第 156 周时达到 ACR20，继续接受 filgotinib 200mg 和 100mg 的患者分别有 67.3%和 59.5%达到 ACR20。在第 156 周时，分别有 18.8%和 15.4%接受新的 filgotinib 200mg 和 100mg 治疗的患者达到布尔缓解 1.0，当应用布尔 2.0 标准时，分别有 21.1%和 18.5%的患者达到布尔缓解 1.0。在来自 FINCH 2 和 3 的患者中也观察到了类似的疗效数据。安全性数据与 filgotinib 的已知安全性特征一致。
在 FINCH 4 中，在来自 FINCH 1、2 或 3 的患者中，filgotinib 200mg 和 100mg（连续或新）持续至第 156 周时表现出持续疗效，无意外安全性结果。
