介绍
在免疫介导的疾病中长期使用皮质类固醇与不良事件 (AE) 风险增加和健康相关生活质量 (HRQoL) 恶化相关。先前的研究报告称，长期大剂量皮质类固醇治疗会导致医疗资源使用率和 AE 相关医疗费用更高。最近的研究表明 Acthar ® Gel（促肾上腺皮质激素注射剂）是治疗结节病的一种有效的类固醇节约疗法。本研究比较了 Acthar Gel 和对照药物之间的皮质类固醇节约效果，并评估了 Acthar Gel 坚持使用对减少皮质类固醇负担的影响。
方法
对大型行政药房和医疗索赔数据库（Symphony Health Solutions）进行了回顾性分析。研究期间 (2014-2020) 纳入经 ICD-9/10 确诊为结节病的患者，随后≥ 2 项 Acthar Gel 声明或比较药物（Janus 激酶抑制剂 (JAKi)/利妥昔单抗），≥ 18 岁，其中 12 名患者前/后指数的月份覆盖率。结果以相对于基线的变化进行比较。 Acthar Gel 的依从性由随访期间的天数比例决定。
结果
Acthar Gel ( n = 735) 和对照组 ( n = 626) 队列大多数为女性 (68-72%)，年龄在 55 至 58 岁之间。与基线时的比较队列相比，Acthar Gel 患者的皮质类固醇使用率更高（80% vs. 56%， p < 0.001），延长使用时间（61% vs. 32%， p < 0.001），平均每日剂量（ 6.72 与 3.03， p < 0.001）。治疗后，Acthar Gel 患者的皮质类固醇使用量较基线显着减少（– 9.0% vs. – 3.2%）并延长使用（– 10.0% vs. – 3.0%）。在 Acthar Gel 依从性队列中，依从性高于平均水平的患者比依从性低于平均水平的患者在两项指标上的下降幅度更大（分别为 – 11.2% 与 – 6.1%； – 11.6% 与 – 7.6%）。 Acthar Gel 患者在所有剂量水平下的长期使用都有更大程度的减少。
结论
与替代品相比，Acthar Gel 可减少皮质类固醇的使用。更好的依从性与皮质类固醇暴露的更大减少有关。
要点总结
"点击查看英文标题和摘要"
Corticosteroid Use and Adherence in Patients Treated with Acthar Gel for Advanced Sarcoidosis
Introduction
Long-term corticosteroid use in immune-mediated diseases is associated with increased risk of adverse events (AEs) and worsened health-related quality of life (HRQoL). Previous studies report chronic high-dose corticosteroid therapy results in higher rates of healthcare resource use and AE-related medical costs. Recent studies suggest Acthar® Gel (repository corticotropin injection) is an effective steroid-sparing therapy for sarcoidosis. This study compares the corticosteroid-sparing effect between Acthar Gel and comparators and evaluates the impact of Acthar Gel adherence on reduction of corticosteroid burden.
Methods
A retrospective analysis of a large administrative pharmacy and medical claims database (Symphony Health Solutions) was conducted. Patients were included with confirmed ICD-9/10 diagnosis for sarcoidosis in the study period (2014–2020), followed by ≥ 2 Acthar Gel claims or comparators (janus kinase inhibitor (JAKi)/rituximab), ≥ 18 years old, with 12 months coverage pre/post index. Outcomes were compared as change from baseline. Acthar Gel adherence was determined by proportion of days covered in the follow-up period.
Results
The Acthar Gel (n = 735) and comparator (n = 626) cohorts were mostly female (68–72%) between 55 and 58 years old. Compared to the comparator cohort at baseline, Acthar Gel patients had greater any corticosteroid use (80% vs. 56%, p < 0.001), extended use (61% vs. 32%, p < 0.001), and mean average daily dose (6.72 vs. 3.03, p < 0.001). After treatment, Acthar Gel patients had greater reduction from baseline in any corticosteroid use (– 9.0% vs. – 3.2%) and extended use (– 10.0% vs. – 3.0%). In the Acthar Gel adherence cohorts, patients with above average adherence had greater reduction in both measures (– 11.2% vs. – 6.1%; – 11.6% vs. – 7.6%, respectively) than patients with below average adherence. Acthar Gel patients had greater reduction of extended use at all dose levels.
Conclusion
Acthar Gel is associated with reductions in corticosteroid use compared to alternatives. Better adherence is associated with greater reduction in corticosteroid exposure.
Key Summary Points
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