Daratumumab在美国多发性骨髓瘤患者中的真实使用期限和给药频率。

Rafael Fonseca MD , Eric E. Chinaeke PhD , Niodita Gupta-Werner MD, MPH, PhD , Alex Z. Fu PhD , Shuchita Kaila PhD
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引用次数: 0

摘要

Daratumumab(DARA)是一种抗CD38单克隆抗体,被批准作为新诊断的多发性骨髓瘤(MM)的联合疗法,以及复发或难治性MM病例的单一疗法和联合疗法。我们评估了DARA在不同治疗线中的使用时间,以及现实世界中MM患者中断治疗的概率。我们使用Optum的已识别临床数据集市数据库来识别2015年11月1日至2021年3月31日期间在美国接受含DARA治疗的MM患者(n=2124)。如果患者接受了干细胞移植,则将其排除在外。DARA使用的持续时间定义为首次启动和停止DARA之间的时间间隔,作为使用Kaplan-Meier方法的时间-事件结果。两次DARA索赔日期之间的间隔超过60天被定义为DARA中止。DARA持续使用的中位持续时间为16.6个月。到24个月时,33.1%的患者仍在接受DARA治疗。在对连续保险期为12个月或12个月以上的患者(n=1246)进行的亚组分析中,DARA使用的中位时间为24.7个月;到24个月,51.8%的患者仍在接受DARA治疗。剂量依从性比率(观察到的DARA剂量相对于标签)接近1.0,尤其是在随访时间较长的患者中,这表明真实世界的DARA给药频率与批准标签上的相似。总之,这项真实世界的分析报告称,连续使用DARA的中位持续时间为16.6个月,MM患者的给药依从性很高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Real-world Duration of Use and Dosing Frequency of Daratumumab in Patients With Multiple Myeloma in the United States

Real-world Duration of Use and Dosing Frequency of Daratumumab in Patients With Multiple Myeloma in the United States

Daratumumab (DARA) is an anti-CD38 monoclonal antibody approved as a combination therapy for newly diagnosed multiple myeloma (MM) and as monotherapy and combination therapy for relapsed or refractory MM cases. We assessed the length of DARA use across lines of therapy and the probabilities of treatment discontinuation in patients with MM in the real-world. We used the deidentified Clinformatics Data Mart database from Optum to identify patients with MM (n=2124) who received DARA-containing treatment between November 1, 2015 and March 31, 2021 in the United States. Patients were excluded if they had received a stem cell transplant. The duration of DARA use was defined as the time interval between the first initiation and discontinuation of DARA as a time-to-event outcome using the Kaplan-Meier method. A gap of more than 60 days between 2 consequent DARA claim dates was defined as DARA discontinuation. The median duration of continuous DARA use was 16.6 months. By 24 months, 33.1% of patients remained on DARA treatment. In a subgroup analysis of patients with 12 months or more continuous insurance coverage (n=1246), the median length of DARA use was 24.7 months; by 24 months, 51.8% remained on DARA treatment. The dose adherence ratios (observed DARA doses relative to the label) were close to 1.0, particularly among patients with longer follow-up, indicating that real-world DARA dosing frequency was similar to that on the approved label. In summary, this real-world analysis reported that the median duration of continuous DARA use is 16.6 months, with high dosing adherence in patients who have MM.

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来源期刊
Mayo Clinic proceedings. Innovations, quality & outcomes
Mayo Clinic proceedings. Innovations, quality & outcomes Surgery, Critical Care and Intensive Care Medicine, Public Health and Health Policy
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