Buch Maya H, Walker David, Edwards Christopher J, Barry Jane, Akroyd Laura, Ekoka Omoruyi Edmund V, Taylor Peter C
Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK.
Department of Rheumatology, Northumbria Healthcare NHS Foundation Trust, North Shields, UK.
Rheumatology (Oxford). 2025 Apr 1;64(4):1661-1671. doi: 10.1093/rheumatology/keae486.
Clinical trials restricted to moderately active RA are limited. Filgotinib is approved for treating moderate to severe active RA. This post hoc analysis assessed the efficacy and safety of filgotinib in moderately active RA.
In FINCH 1, patients with active moderate to severe RA and inadequate response to methotrexate received filgotinib 200 mg or 100 mg (FIL200/FIL100) once daily, adalimumab 40 mg every 2 weeks or placebo, all with methotrexate (N = 1755). This subgroup analysis was conducted in patients with a moderate baseline Disease Activity Score in 28 joints using C-reactive protein [DAS28-CRP; >3.2 to ≤5.1; n = 425 (24.2%)].
A higher proportion of patients achieved DAS28-CRP <2.6, Clinical Disease Activity Index (CDAI) remission (≤2.8), low disease activity (LDA) (DAS28-CRP ≤3.2 or CDAI ≤10) and American College of Rheumatology (ACR20/50/70) responses with FIL200 and FIL100 vs placebo at weeks 12 and 24. Week 12 ACR20 response rates (primary end point) were 77.9%, 67.8% and 43.8%, respectively. A total of ∼75% of patients achieved DAS28-CRP LDA by week 24 with either filgotinib dose. FIL200 and FIL100 elicited greater improvements in patient-reported outcomes than placebo. The efficacy of filgotinib, maintained through week 52, was comparable to that of adalimumab. Frequency of adverse events (AEs) was similar with filgotinib and adalimumab. Infections were the most common AEs; incidence rates were 40-53% in active treatment groups.
In this subpopulation with moderately active RA, the efficacy and safety of filgotinib were similar to those in the overall FINCH 1 population (patients with active moderate to severe RA).
ClinicalTrials.gov, http://clinicaltrials.gov, NCT02889796.
局限于中度活动型类风湿关节炎（RA）的临床试验有限。非戈替尼已获批用于治疗中度至重度活动性RA。这项事后分析评估了非戈替尼在中度活动型RA中的疗效和安全性。
在FINCH 1研究中，对甲氨蝶呤反应不足的中度至重度活动性RA患者接受每日一次200mg或100mg非戈替尼（FIL200/FIL100）、每2周一次40mg阿达木单抗或安慰剂治疗，均联合甲氨蝶呤（N = 1755）。该亚组分析纳入了28个关节的疾病活动评分（使用C反应蛋白）处于中度基线水平[疾病活动评分28-CRP（DAS28-CRP）>3.2至≤5.1；n = 425（24.2%）]的患者。
在第12周和第24周时，与安慰剂相比，接受FIL200和FIL100治疗的患者达到DAS28-CRP<2.6、临床疾病活动指数（CDAI）缓解（≤2.8）、低疾病活动度（LDA）（DAS28-CRP≤3.2或CDAI≤10）以及美国风湿病学会（ACR20/50/70）反应的比例更高。第12周时的ACR20反应率（主要终点）分别为77.9%、67.8%和43.8%。使用任一非戈替尼剂量治疗的患者在第24周时约75%达到DAS28-CRP低疾病活动度。与安慰剂相比，FIL200和FIL100在患者报告结局方面有更大改善。非戈替尼的疗效维持至第52周，与阿达木单抗相当。非戈替尼和阿达木单抗的不良事件（AE）发生率相似。感染是最常见的AE；在活性治疗组中的发生率为40 - 53%。
在这个中度活动型RA亚组中，非戈替尼的疗效和安全性与FINCH 1总体人群（中度至重度活动性RA患者）相似。
ClinicalTrials.gov，http://clinicaltrials.gov，NCT02889796 。
