Cheng Fang, Wu Di, Cui Zheng, Li Qiang, Li Weiming, Zhang Yu
Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Hubei Key Laboratory of Biological Targeted Therapy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Ther Adv Hematol. 2024 Aug 15;15:20406207241270806. doi: 10.1177/20406207241270806. eCollection 2024.
Generics imatinib became an alternative treatment option for chronic myeloid leukemia (CML) patients in China. However, clinicians and patients alike harbor concerns regarding the long-term safety of generic imatinib.
Patients with chronic phase CML receiving frontline imatinib treatment.
A retrospective study was used to evaluate the blood concentration, effectiveness, and safety of generic in 170 CML patients.
Imatinib plasma concentrations were detected by high-performance liquid chromatography-tandem mass spectrometry.
Among the 170 patients, 73 (42.9%) patients treated with branded imatinib as first-line therapy, while 22 (12.9%) switched to generic imatinib during treatment due to economic considerations. No significant differences in trough concentrations between branded and generic imatinib (1549.9 ± 648.8 ng/mL vs 1479.0 ± 507.0 ng/mL; = 0.95). During the 2-year follow-up, there were no significant differences in molecular response rates (major molecular response (MMR): 33.3% vs 37.0%; deep molecular response: 56.9% vs 42.9%, = 0.17) between the branded and generic imatinib. Both groups showed similar rates of switching to second-generation tyrosine kinase inhibitor (11.8% vs 15.1%, = 0.56). Furthermore, there were no significant differences in event-free survival or failure-free survival between branded and generic imatinib. Twenty-two (12.9%) switched to generic imatinib during treatment, 68.2% maintained their level of response, 27.3% improved, and only one patient (4.5%) lost MMR. There were no significant differences in the incidence of various adverse events.
Generic imatinib are equally effective and safe compared to branded molecules, both for newly diagnosed patients and those who switch from branded.
在中国，伊马替尼仿制药成为慢性髓性白血病（CML）患者的一种替代治疗选择。然而，临床医生和患者都对伊马替尼仿制药的长期安全性存在担忧。
慢性期CML患者接受一线伊马替尼治疗。
采用回顾性研究评估170例CML患者使用仿制药的血药浓度、有效性和安全性。
通过高效液相色谱-串联质谱法检测伊马替尼血浆浓度。
170例患者中，73例（42.9%）患者一线接受原研伊马替尼治疗，22例（12.9%）患者因经济因素在治疗期间换用伊马替尼仿制药。原研伊马替尼与仿制药的谷浓度无显著差异（1549.9±648.8 ng/mL对1479.0±507.0 ng/mL；P=0.95）。在2年随访期间，原研伊马替尼与仿制药在分子反应率方面无显著差异（主要分子反应（MMR）：33.3%对37.0%；深度分子反应：56.9%对42.9%，P=0.17）。两组转换为第二代酪氨酸激酶抑制剂的比例相似（11.8%对15.1%，P=0.56）。此外，原研伊马替尼与仿制药在无事件生存期或无失败生存期方面无显著差异。22例（12.9%）患者在治疗期间换用伊马替尼仿制药，68.2%的患者维持反应水平，27.3%的患者反应改善，仅1例患者（4.5%）失去MMR。各种不良事件的发生率无显著差异。
对于新诊断患者以及从原研药转换过来的患者，伊马替尼仿制药与原研药在有效性和安全性方面相当。
