Schlosspark-Klinik, University Medicine Berlin, Heubnerweg 2, 14059, Berlin, Germany.
Université Paris-Saclay, AP-HP, Hospital Bicêtre, INSERM UMR1184, Le Kremlin Bicêtre, France.
Clin Rheumatol. 2022 Aug;41(8):2361-2373. doi: 10.1007/s10067-022-06176-1. Epub 2022 May 10.
To evaluate retention, efficacy, and safety of subcutaneous (SC) abatacept over 2 years in patients with moderate-to-severe RA in the Abatacept SubCutaneOus in Routine clinical practicE (ASCORE) study.
Patients with RA who initiated SC abatacept 125 mg once weekly were enrolled in the international, observational, prospective multicentre ASCORE study into biologic-naïve or ≥ 1 prior biologic failure cohorts.
abatacept retention rate at 2 years. Secondary endpoints: proportion of patients with good/moderate EULAR response rates based on DAS28 (ESR), low disease activity and/or remission according to DAS28 (ESR; ≤ 3.2/ < 2.6), SDAI (≤ 11/ ≤ 3.3), CDAI (≤ 10/ ≤ 2.8), and Boolean criteria. Retention rate by baseline serostatus was evaluated post hoc.
Overall, 47% of patients remained on abatacept for 2 years, irrespective of treatment line. Higher abatacept retention rates were associated with lower prior biologic exposure. Generally, clinical outcomes showed that the proportion of patients with low disease activity/remission was higher in biologic-naïve patients (vs biologic-failure) and similar in those with 1 and ≥ 2 prior biologic failures. In patients on treatment at 2 years, good/moderate EULAR response rates of ~ 80% were consistently noted irrespective of prior biologic exposure. Across treatment lines, retention was greater in patients with seropositive (vs seronegative) RA. Patients with rheumatoid factor/anti-citrullinated protein antibody single-positive RA who were bio-naïve had higher retention than patients who were bio-experienced.
In the ASCORE study, SC abatacept retention was 47% at 2 years with good clinical outcomes and was well-tolerated in the real-world setting. Abatacept retention and clinical response rates were higher in patients who received abatacept as an earlier- versus later-line biologic drug treatment and in those with seropositive RA.
ClinicalTrials.gov, NCT02090556.
评估皮下注射（SC）阿巴西普在中度至重度 RA 患者中的 2 年保留率、疗效和安全性，这项研究为 Abatacept SubCutaneOus in Routine clinical practicE（ASCORE）。
接受 SC 阿巴西普 125mg 每周一次治疗的 RA 患者入组这项国际、观察性、前瞻性、多中心 ASCORE 研究，分为生物初治或≥1 种生物失败患者队列。
2 年时阿巴西普保留率。次要终点：根据 DAS28（ESR）评估的 EULAR 良好/中度反应率、根据 DAS28（ESR；≤3.2/<2.6）、SDAI（≤11/≤3.3）、CDAI（≤10/≤2.8）和布尔标准评估的低疾病活动度和/或缓解率。基于基线血清学状态评估保留率。
总体而言，无论治疗线如何，47%的患者 2 年时仍在接受阿巴西普治疗。较高的阿巴西普保留率与较低的生物暴露量相关。一般而言，临床结果显示，生物初治患者（与生物失败患者相比）低疾病活动度/缓解率较高，而仅接受 1 种和≥2 种生物失败治疗的患者之间无差异。在治疗 2 年的患者中，无论生物暴露情况如何，始终观察到 80%左右的患者有良好/中度 EULAR 反应率。在所有治疗线中，血清阳性（与血清阴性）RA 患者的保留率更高。初治且 RF/抗 CCP 抗体单阳性 RA 患者的保留率高于生物经验患者。
在 ASCORE 研究中，SC 阿巴西普的 2 年保留率为 47%，具有良好的临床疗效，且在真实环境中具有良好的耐受性。阿巴西普的保留率和临床反应率在作为早期生物药物治疗和血清阳性 RA 的患者中更高。
ClinicalTrials.gov，NCT02090556。
