Teva Pharmaceutical Industries Ltd, 12 Hatrufa St, 4250483, Netanya, Israel.
Teva Pharmaceutical Industries Ltd, 400 Interpace Pkwy, Parsippany, NJ, 07054, USA.
Support Care Cancer. 2022 Nov;30(11):9191-9201. doi: 10.1007/s00520-022-07341-7. Epub 2022 Aug 31.
Lipegfilgrastim (Lonquex, Teva Pharma B.V.) is approved for reduction in neutropenia duration and febrile neutropenia incidence. In the framework of lipegfilgrastim regulatory approval in the EU, the Health Authorities requested a drug utilization study. This study was conducted to characterize prescribing patterns of lipegfilgrastim and quantify the extent of on- and off-label use of lipegfilgrastim in real-world setting in Europe.
Information on lipegfilgrastim use between January 2014 and March 2020 was abstracted from medical records in hospital and outpatient clinical settings. Indication for lipegfilgrastim was classified either as on-label or off-label use according to pre-determined criteria. The primary endpoint was the extent of lipegfilgrastim off-label use based on the most recent lipegfilgrastim cycle.
Records of 481 patients were obtained from five European countries. Lipegfilgrastim was most commonly prescribed for prevention of neutropenia by oncologists and hematologists. Patients who were administered lipegfilgrastim were primarily ≥ 55 years old (65.1%) and female (65.7%). The most frequent underlying diagnosis was breast cancer (38.3%). For the most recent lipegfilgrastim cycle, on-label use was recorded in 452/459 patients with no missing data (98.5%), while off-label use was recorded in 7/459 patients (1.5%). The majority of off-label use was attributed to use with non-cytotoxic chemotherapy (57.1%). Off-label use of lipegfilgrastim across all treatment cycles with no missing data was 11/1547 cycles (0.7%).
Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication.
Lipegfilgrastim（Lonquex，Teva Pharma B.V.）已获批准用于减少中性粒细胞减少症的持续时间和发热性中性粒细胞减少症的发生率。在欧盟批准 lipegfilgrastim 的监管框架内，卫生当局要求进行一项药物利用研究。本研究旨在描述 lipegfilgrastim 的处方模式，并量化欧洲真实环境中 lipegfilgrastim 的标签内和标签外使用程度。
从医院和门诊临床环境的病历中提取 2014 年 1 月至 2020 年 3 月期间 lipegfilgrastim 使用的信息。根据预先确定的标准，将 lipegfilgrastim 的适应证分类为标签内或标签外使用。主要终点是根据最近的 lipegfilgrastim 周期确定的 lipegfilgrastim 标签外使用程度。
从五个欧洲国家获得了 481 名患者的记录。Lipegfilgrastim 最常用于肿瘤学家和血液学家预防中性粒细胞减少症。接受 lipegfilgrastim 治疗的患者主要为≥55 岁（65.1%）和女性（65.7%）。最常见的基础诊断是乳腺癌（38.3%）。对于最近的 lipegfilgrastim 周期，有 452/459 名患者（98.5%）无缺失数据记录为标签内使用，而有 7/459 名患者（1.5%）记录为标签外使用。大多数标签外使用归因于与非细胞毒性化疗联合使用（57.1%）。在所有无缺失数据的治疗周期中，标签外使用 lipegfilgrastim 的比例为 11/1547 个周期（0.7%）。
使用真实世界的数据，这些发现证实了先前可行性研究报告的 lipegfilgrastim 标签外使用率较低，表明非常高的遵循批准的适应证。
