CEIM Investigaciones Médicas, Laprida 1307, Ciudad De Buenos Aires, 1425, Buenos Aires, Argentina.
Centro de Investigación Marbella, Paitilla Panamá, Panamá.
Adv Rheumatol. 2021 Sep 8;61(1):56. doi: 10.1186/s42358-021-00213-4.
Determining potential predictors of clinical response would allow a more personalized rheumatoid arthritis (RA) treatment approach in heterogeneous populations such as Latin American (LA) patients.
Post hoc analysis to identify baseline characteristics predictive of clinical remission in response to treatment with etanercept (ETN) plus methotrexate (MTX) in LA patients with moderate to severe MTX-resistant RA. We report data from the group of patients who received ETN 50 mg/week plus MTX (ETN + MTX, n = 281) in a clinical trial consisting of an initial 24-week open-label phase, followed by a 104-week extension. Remission was defined as 28-joint Disease Activity Score with erythrocyte sedimentation rate (DAS28-ESR) score < 2.6. Cutoff values to dichotomize baseline variables maximizing the detection of remission were obtained from Receiver Operator Curve analyses. Baseline dichotomized and categorical variables were analyzed altogether in a stepwise logistic regression model. Odds of attaining response at Weeks 24 and 128 were estimated for each significant predictor.
At Week 24 and Week 128, 27% (66/241) and 42% (91/219) of patients in the ETN + MTX group achieved remission. On average, patients achieving remission were younger and had lower baseline ESR, lower Physician Global Assessment (PGA) scores, lower total Health Assessment Questionnaire (HAQ) scores, and lower visual analog scale (VAS) Pain scores compared with patients who did not achieve remission. The best subset of baseline variables predicting Week 24 remission in the stepwise regression model were age ≤ 49 years (odds ratio [OR] 2.93), body mass index (BMI) > 28.5 kg/m (OR 3.24), disease duration > 3.7 years (OR 2.22), ESR ≤ 42 mm/h (OR 2.72), PGA ≤ 6 (OR 3.21), tender joint count ≤ 14 (OR 2.25), and total HAQ score ≤ 1.6 (OR 2.86). At Week 128, age ≤ 42 years (OR 2.21), SF-36 Mental Health Scale score > 39.6 (OR 2.16), White race (OR 4.07), > 18 swollen joints (OR 2.11), and VAS Pain ≤ 41 (OR 6.05) at baseline were the best subset of significant predictors of remission.
In LA patients with RA, younger age, higher BMI, longer disease duration, higher SF-36 Mental Health Scale score, higher swollen joint count, and overall lower disease activity predicted clinical response to ETN + MTX therapy.
ClinicalTrials.gov Identifier: NCT00848354.
在拉丁美洲（LA）等异质人群中，确定临床反应的潜在预测因素将允许采用更个性化的类风湿关节炎（RA）治疗方法。
对接受依那西普（ETN）加甲氨蝶呤（MTX）治疗的中重度 MTX 耐药 RA 的 LA 患者进行治疗反应达到临床缓解的基线特征的事后分析。我们报告了来自临床试验中接受 ETN 50mg/周加 MTX（ETN+MTX，n=281）的患者组的数据，该临床试验包括 24 周的开放性标签初始阶段，随后进行 104 周的扩展。缓解定义为红细胞沉降率（ESR）的 28 关节疾病活动评分（DAS28-ESR）评分<2.6。通过接收者操作特征曲线分析获得最大程度检测缓解的截断值，将基线变量二分类。对二分类和分类基线变量进行逐步逻辑回归模型分析。为每个显著预测因子估计了第 24 周和第 128 周达到缓解的几率。
在第 24 周和第 128 周，ETN+MTX 组分别有 27%（66/241）和 42%（91/219）的患者达到缓解。平均而言，达到缓解的患者比未达到缓解的患者年龄更小，基线 ESR、医师总体评估（PGA）评分、总健康评估问卷（HAQ）评分和视觉模拟量表（VAS）疼痛评分更低。在逐步回归模型中，预测第 24 周缓解的最佳基线变量子集为年龄≤49 岁（比值比[OR]2.93）、体重指数（BMI）>28.5kg/m（OR 3.24）、疾病持续时间>3.7 年（OR 2.22）、ESR≤42mm/h（OR 2.72）、PGA≤6（OR 3.21）、压痛关节数≤14（OR 2.25）和总 HAQ 评分≤1.6（OR 2.86）。在第 128 周，年龄≤42 岁（OR 2.21）、SF-36 心理健康量表评分>39.6（OR 2.16）、白种人（OR 4.07）、肿胀关节数>18（OR 2.11）和 VAS 疼痛≤41（OR 6.05）是缓解的最佳基线预测因子子集。
在 RA 拉丁美洲患者中，年轻的年龄、较高的 BMI、较长的疾病持续时间、较高的 SF-36 心理健康量表评分、较高的肿胀关节计数和整体较低的疾病活动度预测了 ETN+MTX 治疗的临床反应。
ClinicalTrials.gov 标识符：NCT00848354。
