METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
方法:对每周一次服用SCabatacept125mg的RA成人进行评估。主要终点是2年的abatacept保留率。次要终点:根据红细胞沉降率(≤3.2),28个关节的低疾病活动度(LDA)/缓解患者的比例,简化疾病活动指数(≤11),和临床疾病活动指数(≤10)。通过治疗线和血清状况分析结果。
结果:对于合并队列,2年abatacept保留率为47.6%;保留率在未接受生物制剂治疗的患者中最高(50.5%[95%置信区间44.9,55.9]).基线时抗瓜氨酸蛋白抗体(ACPA)和类风湿因子(RF;+/+)均为血清阳性的患者2年abatacept保留率高于APCA或RF单一血清阳性或双血清阴性(-/-)的患者,不管治疗路线。在2年,与使用1种或2种以上生物制剂的患者相比,未接受生物制剂治疗的患者在LDA/缓解期的比例更高.
结论:有较高比例的+/+RA患者(与-/-RA相比)在2年后有abatacept保留。早期识别血清反应阳性的RA患者可能有助于RA治疗的精准医学方法。导致LDA/缓解的患者比例更高。
背景:NCT02090556;注册日期:2014年3月18日(回顾性注册)。关键点•对来自全球ASCORE研究(NCT02090556)的一个讲德语的欧洲RA患者子集的事后分析显示,该子集内SCabatacept的保留率为47.6%,2年后具有良好的临床效果。•与双血清阴性RA(ACPA和RF阴性)患者相比,双血清阳性RA(ACPA和RF阳性)患者的abatacept保留率更高。与接受过一种或两种以上生物治疗的患者相比,未接受生物治疗的患者的保留率和临床反应最高。•这些真实数据可能有助于临床医生为RA患者提供个性化治疗途径。并促进更好的疾病控制和临床结果。