Department of Internal Medicine, Rheumatology, Schlosspark-Klinik, University Medicine Berlin, Heubnerweg 2, 14059, Berlin, Germany.
Medizinische Klinik Und Poliklinik II, Rheumatologie/Klinische Immunologie, Universitätsklinikum Würzburg, Josef-Schneider-Straße 2, 97080, Würzburg, Germany.
Clin Rheumatol. 2023 Sep;42(9):2321-2334. doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.
INTRODUCTION/OBJECTIVES: The ASCORE study on treatment for rheumatoid arthritis (RA) showed better retention and clinical response rates for abatacept as first-line versus later-line therapy. This post hoc analysis of ASCORE assessed 2-year retention, efficacy, and safety of subcutaneous (SC) abatacept in Germany, Austria, and Switzerland.
Adults with RA who initiated SC abatacept 125 mg once weekly were assessed. Primary endpoint was abatacept retention rate at 2 years. Secondary endpoints: proportions of patients with low disease activity (LDA)/remission per Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (≤ 3.2), Simplified Disease Activity Index (≤ 11), and Clinical Disease Activity Index (≤ 10). Outcomes were analyzed by treatment line and serostatus.
For the pooled cohort, the 2-year abatacept retention rate was 47.6%; retention was highest in biologic-naïve patients (50.5% [95% confidence interval 44.9, 55.9]). Patients seropositive for both anti-citrullinated protein antibody (ACPA) and rheumatoid factor (RF; + / +) at baseline had a higher 2-year abatacept retention rate than patients with single seropositivity for either APCA or RF or double-seronegativity (- / -), irrespective of treatment line. At 2 years, a higher proportion of patients who were biologic-naïve were in LDA/remission than patients with one or ≥ two prior biologics.
A higher proportion of patients with + / + RA (compared with - / - RA) had abatacept retention after 2 years. Early identification of patients with seropositive RA may facilitate a precision-medicine approach to RA treatment, leading to a higher proportion of patients in LDA/remission.
NCT02090556; date registered: March 18, 2014 (retrospectively registered). Key Points • This post hoc analysis of a German-speaking subset of European patients with RA from the global ASCORE study (NCT02090556) showed that retention of SC abatacept within this subset was 47.6%, with good clinical outcomes after 2 years. • Patients with double-seropositive RA (ACPA and RF positive) had higher retention of abatacept than patients with double-seronegative RA (ACPA and RF negative). Retention and clinical responses were highest for patients who were biologic-naïve compared with patients who had one or ≥ two prior biologic treatments. • These real-world data may be useful for clinicians in informing individualized treatment pathways for patients with RA, and fostering superior disease control and clinical outcomes.
简介/目的：ASCORE 研究表明，相较于后续治疗，在类风湿关节炎（RA）的治疗中，阿巴西普作为一线治疗具有更好的保留率和临床应答率。ASCORE 的这项事后分析评估了德国、奥地利和瑞士使用皮下（SC）阿巴西普的 2 年保留率、疗效和安全性。
纳入初始接受 SC 阿巴西普 125mg、每周一次治疗的 RA 成年患者。主要终点为 2 年时的阿巴西普保留率。次要终点：基于红细胞沉降率（≤3.2）的低疾病活动度（LDA）/缓解比例（≤3.2）、简化疾病活动指数（SDAI）（≤11）和临床疾病活动指数（CDAI）（≤10）的 LDA/缓解患者比例。通过治疗线和血清状态对结局进行分析。
对于汇总队列，阿巴西普的 2 年保留率为 47.6%；在生物制剂初治患者中保留率最高（50.5% [95%置信区间 44.9，55.9]）。基线时抗瓜氨酸化蛋白抗体（ACPA）和类风湿因子（RF）均阳性（+ / +）的患者，与仅 ACPA 或 RF 阳性或双阴性（- / -）的患者相比，2 年时的阿巴西普保留率更高，无论治疗线如何。2 年时，更多生物制剂初治患者达到 LDA/缓解，而非至少一种生物制剂治疗失败的患者。
与- / - RA 相比，+ / + RA 患者（比较）在 2 年后阿巴西普保留率更高。早期识别出 RA 血清阳性患者，可能有助于采用精准医学方法治疗 RA，使更多患者达到 LDA/缓解。
NCT02090556；注册日期：2014 年 3 月 18 日（回顾性注册）。关键点 • 这项来自全球 ASCORE 研究（NCT02090556）的德语区欧洲 RA 患者亚组的事后分析显示，该亚组中 SC 阿巴西普的保留率为 47.6%，2 年后临床结局良好。 • 双阳性 RA（ACPA 和 RF 阳性）患者的阿巴西普保留率高于双阴性 RA（ACPA 和 RF 阴性）患者。与至少一种生物制剂治疗失败的患者相比，生物制剂初治患者的保留率和临床应答率更高。 • 这些真实世界数据可能有助于临床医生为 RA 患者制定个体化治疗途径，并促进疾病更好控制和临床结局。
