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.
Clin Rheumatol. 2019 May;38(5):1413-1424. doi: 10.1007/s10067-019-04449-w. Epub 2019 Feb 21.
Evaluate abatacept retention over 2 years in the AbataCepT In rOutiNe clinical practice (ACTION) study.
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.
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).
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.
NCT02109666.
评估 AbataCepT In rOutiNe 临床实践（ACTION）研究中阿巴西普的 2 年保留率。
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。
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。
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。
NCT02109666。
