Int J Clin Pharmacol Ther. 2022 Nov;60(11):469-476. doi: 10.5414/CP204259.
The effectiveness of imatinib, a tyrosine kinase inhibitor recommended for the treatment of chronic myeloid leukemia, is associated with high adherence and trough plasma imatinib concentrations of ~ 1,000 ng/mL. However, adherence and therapeutic drug monitoring (TDM) for imatinib have hardly been reported. This study evaluated the prevalence of TDM and adherence to imatinib for chronic myeloid leukemia in Japan.
Monthly insurance claims data for ~ 5.6 million individuals aged 20 - 74 years between June 1, 2005 and December 31, 2017 were studied. Patients with at least one prescription for imatinib were included to calculate adherence and the annual mean prevalence of TDM for imatinib.
A total of 498 patients with 9,620 prescriptions of imatinib were included. After 2013, the number of imatinib prescriptions and the number of patients treated with imatinib were over 1,000 and 200, respectively. The mean annual prevalence of TDM for imatinib was 12.2% (95% confidence interval (CI), 8.1 - 16.1%). Antihyperuricemic drugs and steroids increased the likelihood of TDM. The medication possession ratio for assessment of adherence was 93.5% (95% CI: 91.8 - 95.5%). The annual mean prevalence of TDM for imatinib was low, although adherence was high.
To encourage the measurement of plasma concentrations of imatinib in clinical settings, adding a package insert, a summary of product characteristics, and a patient information leaflet regarding the implementation of TDM is justified and warrants further attention.
伊马替尼是一种酪氨酸激酶抑制剂，推荐用于治疗慢性髓性白血病，其疗效与高依从性和 1000ng/ml 左右的伊马替尼谷浓度相关。然而，伊马替尼的依从性和治疗药物监测（TDM）几乎没有报道。本研究评估了日本慢性髓性白血病伊马替尼 TDM 和依从性的流行情况。
研究了 2005 年 6 月 1 日至 2017 年 12 月 31 日期间，约 560 万 20-74 岁人群的每月保险理赔数据。纳入至少有一次伊马替尼处方的患者，以计算伊马替尼的依从性和每年 TDM 的平均流行率。
共纳入 498 例患者（9620 例伊马替尼处方）。2013 年后，伊马替尼处方数量和接受伊马替尼治疗的患者数量分别超过 1000 例和 200 例。伊马替尼 TDM 的年平均流行率为 12.2%（95%置信区间[CI]：8.1-16.1%）。降尿酸药物和类固醇增加了 TDM 的可能性。评估依从性的药物占有率为 93.5%（95%CI：91.8-95.5%）。尽管依从性较高，但伊马替尼 TDM 的年平均流行率较低。
为了鼓励在临床环境中测量伊马替尼的血浆浓度，在说明书、产品特性摘要和患者信息传单中添加有关 TDM 实施的内容是合理的，值得进一步关注。
