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类风湿关节炎患者使用阿巴西普 2 年以上的预测因素:来自真实世界 ACTION 研究的结果。

Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study.

机构信息

Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology, Schlosspark-Klinik University Medicine Berlin, Heubnerweg 2, 14059, Berlin, Germany.

Department of Rheumatology, Université Paris-Sud, Paris, France.

出版信息

Clin Rheumatol. 2019 May;38(5):1413-1424. doi: 10.1007/s10067-019-04449-w. Epub 2019 Feb 21.

Abstract

OBJECTIVES

Evaluate abatacept retention over 2 years in the AbataCepT In rOutiNe clinical practice (ACTION) study.

METHOD

ACTION was an international, observational study of patients with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. Crude abatacept retention rates over 2 years were estimated using Kaplan-Meier analyses in biologic-naive and -failure patients. Clinically relevant risk factors and significant prognostic factors for retention were evaluated using a Cox proportional hazards multivariable model.

RESULTS

Overall, 2350/2364 enrolled patients were evaluable; 673 (28.6%) were biologic naive and 1677 (71.4%) had prior biologic failure (1 biologic, 728/1677 [43.4%]; ≥ 2 biologics, 949/1677 [56.6%]). Abatacept retention rate (95% confidence interval [CI]) at 2 years was 47.9% (45.7, 50.0): 54.5% (50.4, 58.3) for biologic-naive vs 45.2% (42.7, 47.7) for biologic-failure patients (log-rank P < 0.001). For patients with 1 and ≥ 2 prior biologic failures, respectively, retention rates (95% CI) were 50.2% (46.3, 53.9) vs 41.3% (38.0, 44.6; log-rank P < 0.001). Main reasons for discontinuation (biologic-naive vs biologic-failure, respectively) were lack of efficacy (61.4 vs 67.7%) and safety (21.3 vs 21.2%). Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) double positivity versus negativity were predictive of higher retention in both biologic-naive (hazard ratio [HR] [95% CI] 0.71 [0.53, 0.96]; P = 0.019) and biologic-failure patients (HR [95% CI] 0.76 [0.62, 0.94]; P = 0.035).

CONCLUSIONS

Abatacept initiation as earlier vs later line of therapy in RA may achieve higher 2-year retention rates. RF and anti-CCP seropositivity could predict increased abatacept retention, irrespective of treatment line.

TRIAL REGISTRATION

NCT02109666.

摘要

目的

评估 AbataCepT In rOutiNe 临床实践(ACTION)研究中阿巴西普的 2 年保留率。

方法

ACTION 是一项针对开始静脉注射阿巴西普的中度至重度类风湿关节炎(RA)患者的国际观察性研究。采用 Kaplan-Meier 分析评估生物初治和生物失败患者的 2 年阿巴西普保留率。使用 Cox 比例风险多变量模型评估保留的临床相关风险因素和显著预后因素。

结果

共纳入 2364 例患者,其中 2350 例可评估;673 例(28.6%)为生物初治患者,1677 例(71.4%)有生物治疗失败史(1 种生物制剂,728/1677 [43.4%];≥2 种生物制剂,949/1677 [56.6%])。2 年阿巴西普保留率(95%置信区间[CI])为 47.9%(45.7,50.0):生物初治患者为 54.5%(50.4,58.3),生物治疗失败患者为 45.2%(42.7,47.7)(对数秩检验 P<0.001)。分别有 1 种和≥2 种既往生物失败史的患者的保留率(95%CI)分别为 50.2%(46.3,53.9)和 41.3%(38.0,44.6;对数秩检验 P<0.001)。停药的主要原因(生物初治 vs 生物治疗失败)分别为疗效不佳(61.4% vs 67.7%)和安全性(21.3% vs 21.2%)。类风湿因子(RF)和抗环瓜氨酸肽(抗-CCP)双阳性与阴性相比,在生物初治(风险比[HR] [95%CI] 0.71 [0.53,0.96];P=0.019)和生物治疗失败患者(HR [95%CI] 0.76 [0.62,0.94];P=0.035)中均与更高的保留率相关。

结论

在 RA 中,阿巴西普起始治疗线更早而非更晚,可能实现更高的 2 年保留率。RF 和抗-CCP 血清阳性可预测阿巴西普保留率增加,与治疗线无关。

试验注册

NCT02109666。

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