一项随机、双盲、平行设计、重复给药、两组、多中心研究，比较denosumab生物类似药AVT03对绝经后骨质疏松症妇女的疗效、安全性、免疫原性和药代动力学特征。

IF 4 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2025-07-28 DOI:10.1080/14712598.2025.2538609

Mamuka Lortkipanidze, Tobie de Villiers, Grzegorz Kania, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Masna Rai, Halimu Haliduola, Hendrik Otto, Abid Sattar, Steffen Leutz, Fausto Berti

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引用次数: 0

摘要

背景：为了证明AVT03（一种推荐的denosumab生物类似药）与参考产品（RP）在绝经后骨质疏松症妇女中的比较疗效。研究设计与方法：受试者接受AVT03或RP；第1天和第6个月皮下注射60毫克。在第12个月，AVT03组给予第3剂，RP组给予第3剂RP或AVT03。主要终点是12个月时腰椎骨密度（BMD）较基线变化的百分比，以及0-6个月时血清I型胶原c末端末端肽（sCTX-1）较基线变化的百分比（%Cfb）。安全性和免疫原性进行了评价。结果：从基线到第12个月腰椎骨密度变化百分比的95%最小二乘置信区间（CI）s包含在预定的范围内（-1.45%,1.45%），支持比较疗效的证明。%Cfb sCTX-1在AUEC0-6个月的治疗组间几何平均比值（0.97,1.03）的95% ci完全包含在预定的范围内（0.80,1.25），支持药效学相似性的证明。安全性和免疫原性在整个过程中具有可比性。结论：数据支持AVT03与RP denosumab的比较疗效。安全性和免疫原性相似。试验注册：https://www.clinicaltrials.gov标识符为NCT05395091。

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A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis.

Background: To demonstrate comparative efficacy of AVT03, a proposed denosumab biosimilar, versus reference product (RP) in postmenopausal women with osteoporosis.

Research design and methods: Participants received AVT03 or RP; 60 mg subcutaneous on Day 1 and Month 6. At Month 12, AVT03 group received 3^rd dose while RP group received either a 3^rd dose of RP or a dose of AVT03. Primary endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months and area under the effect curve (AUEC)_0-6 months of percent change from baseline (%Cfb) in serum C-terminal telopeptide of type I collagen (sCTX-1). Safety and immunogenicity were evaluated.

Results: The 95% confidence interval (CI)s of the least squares means difference between treatments for percent change from baseline in lumbar spine BMD to Month 12 (-0.58, 0.82) were entirely contained within the prespecified margin (-1.45%, 1.45%), supporting demonstration of comparative efficacy. The 95% CIs of the geometric mean ratio between treatments for AUEC_0-6 months of %Cfb sCTX-1 (0.97, 1.03) were entirely contained within the prespecified margin (0.80, 1.25), supporting demonstration of pharmacodynamic similarity. Safety and immunogenicity profiles were comparable throughout.

Conclusion: Data supported demonstration of comparative efficacy between AVT03 and RP denosumab. Safety and immunogenicity profiles were similar.

Trial registration: www.clinicaltrials.gov identifier is NCT05395091.

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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.