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在多发性骨髓瘤患者中,通用型普乐沙福与莫扎比利作为辅助外周血干细胞动员剂的疗效比较。

Comparison of the efficacy of a generic plerixafor versus Mozobil as adjunct peripheral blood stem cell mobilization agents in multiple myeloma patients.

作者信息

Yuan Shan, Chang Shelley, Kim Hoim, Wang Shirong

机构信息

Division of Transfusion Medicine, Department of Pathology, City of Hope National Medical Center, Duarte, California, USA.

Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.

出版信息

Transfusion. 2024 Dec;64(12):2332-2340. doi: 10.1111/trf.18033. Epub 2024 Oct 4.

Abstract

BACKGROUND

Plerixafor is an adjunct peripheral blood stem cell (PBSC) mobilization agent with well-demonstrated safety and efficacy. The routine use of the originator brand drug (Mozobil) has been limited by cost. This retrospective study was conducted to compare the mobilization efficacy of a lower-cost generic plerixafor and Mozobil in multiple myeloma (MM) patients.

STUDY DESIGN AND METHODS

The study included two near-concurrent cohorts of MM patients mobilized with brand (n = 64) or generic (n = 61) plerixafor in addition to filgrastim. Collection and early engraftment outcomes were compared.

RESULTS

The two cohorts had comparable distributions of sex, age, and weight. Previous treatment histories and proportions of upfront versus just-in-time plerixafor use were similar. There was no significant difference in their median overall cumulative total yield (10 CD34+ cells/kg) (brand, 5.91; generic, 5.80; p = .51). However, the generic cohort had a significantly higher median yield after the first dose (4.79 vs. 3.78, p = .03), and consequently lower median numbers of plerixafor doses (p = .001) and collection days (p = .002). Only 31.1% of patients in the generic arm required more than one dose versus 59.4% of patients in the brand arm (p = .006). All transplanted patients in the brand and generic arms (90.6% and 85.2% respectively, p = .42) achieved engraftment. There was no significant difference in their median times to platelet and neutrophil engraftment, nor their transfusion requirements during the first 30 days post-transplant.

CONCLUSION

The generic plerixafor produced comparable cumulative collection yields and early engraftment outcomes as Mozobil, but fewer doses and collection days were needed to reach collection goal.

摘要

背景

普乐沙福是一种辅助外周血干细胞(PBSC)动员剂,其安全性和有效性已得到充分证实。原研品牌药物(莫泽比利)的常规使用受到成本限制。本回顾性研究旨在比较低成本的普乐沙福仿制药与莫泽比利在多发性骨髓瘤(MM)患者中的动员效果。

研究设计与方法

该研究纳入了两个几乎同时期的MM患者队列,除了非格司亭外,分别使用品牌普乐沙福(n = 64)或普乐沙福仿制药(n = 61)进行动员。比较了采集和早期植入结果。

结果

两个队列在性别、年龄和体重分布上具有可比性。既往治疗史以及预先使用与即时使用普乐沙福的比例相似。它们的中位总体累积总产量(每千克10个CD34+细胞)无显著差异(品牌药为5.91;仿制药为5.80;p = 0.51)。然而,仿制药队列在首剂后的中位产量显著更高(4.79对3.78,p = 0.03),因此普乐沙福的中位剂量数更低(p = 0.001),采集天数也更少(p = 0.002)。仿制药组仅31.1%的患者需要一剂以上,而品牌药组为59.4%的患者(p = 0.006)。品牌药组和仿制药组的所有移植患者(分别为90.6%和85.2%,p = 0.42)均实现了植入。它们在血小板和中性粒细胞植入的中位时间以及移植后前30天的输血需求方面无显著差异。

结论

普乐沙福仿制药产生的累积采集产量和早期植入结果与莫泽比利相当,但达到采集目标所需的剂量和采集天数更少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d104/11637246/5eff7c48e69d/TRF-64-2332-g001.jpg

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