Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK.
Ann Rheum Dis. 2012 Jun;71(6):989-92. doi: 10.1136/annrheumdis-2011-201066. Epub 2012 Mar 8.
The objective of this post hoc analysis was to test the benefits of treating very early rheumatoid arthritis (VERA; ≤4 months) using COMET trial data. Treatment response in VERA and early rheumatoid arthritis (ERA; >4 months to 2 years) with combination etanercept+methotrexate (ETN+MTX) or MTX monotherapy was compared.
Data assessed at week 52 for baseline disease duration effect included remission (disease activity score (DAS)28 <2.6, SDAI ≤3.3, Boolean), low disease activity (LDA; DAS28 <3.2), Boolean components of remission and radiographic non-progression. Subjects who discontinued because of lack of efficacy were included as non-responders.
Higher proportions of VERA subjects achieved LDA (79%) and DAS28 remission (70%) than ERA (62%, 48%, respectively, p<0.05) with ETN+MTX. Such high responses with MTX monotherapy were not observed (VERA, LDA=47%, DAS28 remission=35%; ERA, 47% and 32% respectively, p>0.70 for each). Regardless of disease duration, no radiographic progression was seen in 80% of subjects with ETN+MTX. In contrast, a higher proportion of VERA subjects showed no radiographic progression compared with ERA subjects treated with MTX (73.9% vs 50%, p=0.01).
Treatment of VERA with ETN+MTX provides qualitatively improved clinical outcomes not seen with MTX monotherapy, supporting the pivotal role of TNF inhibition in early disease.
本事后分析旨在利用 COMET 试验数据检验早期类风湿关节炎(VERA;≤4 个月)早期治疗的获益。比较 VERA 和早期类风湿关节炎(ERA;>4 个月至 2 年)患者接受依那西普+甲氨蝶呤(ETN+MTX)或 MTX 单药治疗的疗效。
评估基线疾病持续时间效应的第 52 周数据包括缓解(疾病活动评分(DAS)28<2.6、简化疾病活动指数(SDAI)≤3.3、二分类)、低疾病活动(DAS28<3.2)、缓解和放射学非进展的二分类成分。因缺乏疗效而停药的患者被视为无应答者。
与 ERA 患者相比,接受 ETN+MTX 治疗的 VERA 患者更易达到 LDA(79%)和 DAS28 缓解(70%)(分别为 ERA 患者的 62%和 48%,p<0.05)。未观察到 MTX 单药治疗有如此高的应答率(VERA,LDA=47%,DAS28 缓解=35%;ERA,分别为 47%和 32%,p>0.70)。无论疾病持续时间如何,80%接受 ETN+MTX 治疗的患者均未出现放射学进展。相比之下,与接受 MTX 治疗的 ERA 患者相比,更多的 VERA 患者未出现放射学进展(73.9%比 50%,p=0.01)。
与 MTX 单药治疗相比,ETN+MTX 治疗 VERA 可提供质量更高的临床结局,这支持 TNF 抑制剂在早期疾病中的关键作用。