Tominaga Ayako, Wada Keiji, Kato Yoshiharu, Okazaki Ken
Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.
Kita Shinagawa 3rd Hospital, Tokyo, Japan.
J Bone Miner Metab. 2025 Jan;43(1):18-21. doi: 10.1007/s00774-024-01570-y. Epub 2024 Dec 7.
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.
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.
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.
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。
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。
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。