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罗莫单抗治疗的反应者和无反应者。

Responders and non-responders to romosozumab treatment.

作者信息

Tominaga Ayako, Wada Keiji, Kato Yoshiharu, Okazaki Ken

机构信息

Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.

Kita Shinagawa 3rd Hospital, Tokyo, Japan.

出版信息

J Bone Miner Metab. 2025 Jan;43(1):18-21. doi: 10.1007/s00774-024-01570-y. Epub 2024 Dec 7.

Abstract

INTRODUCTION

Romosozumab is an anti-sclerostin antibody drug with potent bone formation-promoting and bone resorption-inhibiting properties. It enhances bone mineral density and has a novel effect in preventing fractures. However, there have been reports of non-responders to romosozumab.

FINDINGS

If the least significant change is defined as 3%, only 2-12% of patients with spine osteoporosis are non-responders, and romosozumab is highly effective in this population. Low-type 1 amino-terminal propeptide (P1NP) levels during the early treatment phase are associated with non-responders early in treatment. The researchers found a cutoff value of 50.3 μg/L of P1NP in the first month of treatment. In contrast, hip osteoporosis does not respond (54-57% of the time). Low P1NP levels at the start of treatment increase the risk of non-responders. The cutoff value for P1NP was reported as 53.7 μg/L at the beginning of treatment. However, failure to meet these cutoff values does not necessarily indicate that the patient is a non-responder and does not justify a change in drug administration.

CONCLUSIONS

In spine osteoporosis, romosozumab demonstrates high effectiveness, with approximately 2-12% of patients showing no response. However, in hip osteoporosis, approximately 54-57% do not respond to the treatment with romosozumab.

摘要

引言

罗莫索单抗是一种抗硬化蛋白抗体药物,具有强大的促进骨形成和抑制骨吸收的特性。它可提高骨矿物质密度,并在预防骨折方面具有新的作用。然而,已有关于罗莫索单抗无反应者的报道。

研究结果

如果将最小显著变化定义为3%,那么脊柱骨质疏松症患者中只有2%-12%为无反应者,罗莫索单抗在这一人群中非常有效。治疗早期低1型氨基端前肽(P1NP)水平与治疗早期的无反应者相关。研究人员发现治疗第一个月时P1NP的临界值为50.3μg/L。相比之下,髋部骨质疏松症患者无反应(发生率为54%-57%)。治疗开始时P1NP水平低会增加无反应者的风险。据报道治疗开始时P1NP的临界值为53.7μg/L。然而,未达到这些临界值并不一定表明患者是无反应者,也不能作为改变药物给药的理由。

结论

在脊柱骨质疏松症中,罗莫索单抗显示出高效性,约2%-12%的患者无反应。然而,在髋部骨质疏松症中,约54%-57%的患者对罗莫索单抗治疗无反应。

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