早期类风湿关节炎缓解后和停药时的 flares 预测：阿巴西普治疗 IIIb 期临床试验的事后分析。
Prediction of flare following remission and treatment withdrawal in early rheumatoid arthritis: post hoc analysis of a phase IIIb trial with abatacept.
机构信息
Bristol Myers Squibb, Princeton, NJ, USA.
Philadelphia Veteran's Administration Medical Center and the University of Pennsylvania, Philadelphia, PA, USA.
出版信息
Arthritis Res Ther. 2022 Feb 16;24(1):47. doi: 10.1186/s13075-022-02735-8.
BACKGROUND
Drug-free remission is a desirable goal in rheumatoid arthritis (RA) for both patients and clinicians. The aim of this post hoc analysis was to investigate whether clinical and magnetic resonance imaging (MRI) variables in patients with early RA who achieved remission with methotrexate and/or abatacept at 12 months could predict disease flare following treatment withdrawal.
METHODS
In the AVERT study of abatacept in early RA, patients with low disease activity at month 12 entered a 12-month period with all treatment discontinued (withdrawal, WD). This post hoc analysis assessed predictors of disease flare at WD+6months (mo) and WD+12mo of patients with Disease Activity Score in 28 joints (DAS28)-defined remission (DAS28[C-reactive protein (CRP)] <2.6) at withdrawal using univariate and multivariable regression models. Predictors investigated included the Health Assessment Questionnaire-Disability Index (HAQ-DI), pain, Patient Global Assessment; MRI synovitis, erosion, bone edema, and combined (synovitis + bone edema) inflammation scores.
RESULTS
Remission was achieved by 172 patients; 100 (58%) and 113 (66%) patients had experienced a flare at WD+6mo and WD+12mo, respectively. In univariate analyses, higher HAQ-DI and MRI synovitis, erosion, bone edema, and combined inflammation scores at WD were identified as potential predictors of flare (P ≤ 0.01). In multivariable analysis, high scores at WD for HAQ-DI and MRI erosion were confirmed as independent predictors of flare at WD+6mo and WD+12mo (P < 0.01).
CONCLUSION
In patients with early RA achieving clinical remission, patient function (HAQ-DI), and MRI measures of bone damage (erosion) predicted disease flare 6 and 12 months after treatment withdrawal. These variables may help identify patients with early RA in clinical remission as candidates for successful treatment withdrawal.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT01142726 (date of registration: June 11, 2010).
背景
对于类风湿关节炎（RA）患者和临床医生而言，无药物缓解是一个理想的目标。本事后分析旨在探讨在 12 个月时使用甲氨蝶呤和/或阿巴西普达到缓解的早期 RA 患者中，治疗停止后疾病复发的预测因素是否与临床和磁共振成像（MRI）变量相关。
方法
在阿巴西普治疗早期 RA 的 AVERT 研究中，12 个月时疾病活动度低的患者进入为期 12 个月的所有治疗停止（停药，WD）期。本事后分析使用单变量和多变量回归模型评估 WD+6 个月（mo）和 WD+12 个月时停药时达到疾病活动评分 28 关节（DAS28）定义缓解（DAS28[C 反应蛋白（CRP）] <2.6）的患者疾病复发的预测因素。研究的预测因素包括健康评估问卷残疾指数（HAQ-DI）、疼痛、患者总体评估；MRI 滑膜炎、侵蚀、骨水肿和联合（滑膜炎+骨水肿）炎症评分。
结果
172 例患者达到缓解；100 例（58%）和 113 例（66%）患者在 WD+6mo 和 WD+12mo 时出现复发。单变量分析显示，WD 时 HAQ-DI 和 MRI 滑膜炎、侵蚀、骨水肿和联合炎症评分较高是复发的潜在预测因素（P ≤ 0.01）。多变量分析证实，WD 时 HAQ-DI 和 MRI 侵蚀评分较高是 WD+6mo 和 WD+12mo 复发的独立预测因素（P < 0.01）。
结论
在达到临床缓解的早期 RA 患者中，患者功能（HAQ-DI）和 MRI 骨损伤（侵蚀）的测量值可预测治疗停药后 6 个月和 12 个月时的疾病复发。这些变量可能有助于识别处于临床缓解的早期 RA 患者作为成功停药的候选者。
试验注册
ClinicalTrials.gov，NCT01142726（注册日期：2010 年 6 月 11 日）。
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