Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, USA.
RMD Open. 2024 Mar 12;10(1):e003839. doi: 10.1136/rmdopen-2023-003839.
This post hoc analysis of the FINCH 1-3 (NCT02889796, NCT02873936 and NCT02886728) studies assessed specific effects of filgotinib on pain control and their relationship with other aspects of efficacy in patients with rheumatoid arthritis (RA).
Assessments included: residual pain responses of ≤10 and ≤20 mm on a 100 mm visual analogue scale (VAS); the proportion of patients who achieved VAS pain responses in addition to remission or low disease activity by Disease Activity Score-28 with C-reactive protein (DAS28-CRP) or Clinical Disease Activity Index (CDAI) criteria.
Across studies, filgotinib reduced pain from week 2, with responses sustained throughout the studies. In FINCH 1, at week 24, 35.8%, 25.0%, 24.6% and 11.6% of patients in the filgotinib 200 mg, filgotinib 100 mg, adalimumab and placebo arms (each plus methotrexate) achieved VAS pain ≤20 mm in addition to DAS28-CRP remission; 26.3%, 17.9%, 17.2% and 7.6% achieved VAS pain ≤10 mm in addition to DAS28-CRP remission. A similar pattern was seen for CDAI remission. Time during which VAS pain was ≤10 or ≤20 mm was longest with filgotinib 200 mg and comparable between adalimumab and filgotinib 100 mg. Similar findings were reported for filgotinib in FINCH 2 and 3.
In all RA populations studied, pain improvements occurred from week 2 and were sustained over time. In FINCH 1, filgotinib 100 mg provided similar pain amelioration to adalimumab, whereas filgotinib 200 mg resulted in greater pain improvement and higher proportion of patients with residual pain ≤10 or ≤20 mm and meeting DAS28-CRP remission criteria.
本项 FINCH 1-3 研究（NCT02889796、NCT02873936 和 NCT02886728）的事后分析评估了 filgotinib 对疼痛控制的具体作用及其与类风湿关节炎（RA）患者其他疗效方面的关系。
评估包括：100mm 视觉模拟量表（VAS）上≤10 和≤20mm 的残余疼痛反应；符合 DAS28- C 反应蛋白（DAS28-CRP）或临床疾病活动指数（CDAI）缓解或低疾病活动标准的患者中，filgotinib 治疗组在 VAS 疼痛缓解的比例，此外还有缓解或低疾病活动的患者比例。
在所有研究中，filgotinib 在第 2 周时降低了疼痛，并且在整个研究期间保持了这种缓解。在 FINCH 1 中，在第 24 周时，filgotinib 200mg、filgotinib 100mg、阿达木单抗和安慰剂组（均加用甲氨蝶呤）中，分别有 35.8%、25.0%、24.6%和 11.6%的患者在 DAS28-CRP 缓解的基础上实现了 VAS 疼痛≤20mm；26.3%、17.9%、17.2%和 7.6%的患者在 DAS28-CRP 缓解的基础上实现了 VAS 疼痛≤10mm。CDAI 缓解的情况也类似。VAS 疼痛≤10 或≤20mm 的时间在 filgotinib 200mg 组最长，与阿达木单抗相当，而在 filgotinib 100mg 组则相似。filgotinib 在 FINCH 2 和 3 中的研究结果也相似。
在所有研究的 RA 患者中，疼痛改善从第 2 周开始，并随着时间的推移持续存在。在 FINCH 1 中，filgotinib 100mg 与阿达木单抗提供了相似的疼痛改善效果，而 filgotinib 200mg 则导致了更大的疼痛改善，且有更高比例的患者残余疼痛≤10 或≤20mm，符合 DAS28-CRP 缓解标准。
