Okawa Tokutaro, Okawa Motomi, Koike Tatsuya
Okawa Orthopaedic Surgery Hospital, Domyojimachi 6-12-34, Fujiidera, Osaka, 583-0012, Japan.
Center for Senile Degenerative Disorders (CSDD), Osaka Metropolitan University Graduate School of Medicine, Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan.
J Bone Miner Metab. 2022 Nov;40(6):960-967. doi: 10.1007/s00774-022-01357-z. Epub 2022 Aug 8.
Denosumab has been reported to increase bone mineral density (BMD) and suppress fractures, but poor responders are not uncommon. This study aimed to identify risk factors for poor response to denosumab treatment. This is the first study to explore risk factors for poor response to denosumab.
This retrospective observational study investigated 227 Japanese postmenopausal women who received denosumab with monitoring of BMD by dual-energy X-ray absorptiometry at 6-month intervals. Risk factors were identified using Cox's proportional hazard modeling. Poor responders were defined as not exceeding the least significant change of BMD from baseline for 3 years.
Mean relative change from baseline for 3 years in lumbar spine (LS)-BMD, femoral neck (FN)-BMD, and total hip (TH)-BMD were 12.6%, 6.8%, and 6.1%, respectively. Numbers of poor responders were 10 in LS-BMD, 47 in FN-BMD, 38 in TH-BMD. Risk factors for poor response were concomitant glucocorticoid use for LS-BMD, low body mass index or initiation at higher BMD for FN-BMD, and pretreatment with bisphosphonates or initiation at higher BMD for TH-BMD.
Risk factors for insufficient denosumab effect differed between BMD measurement sites. These results should be taken into consideration when selecting denosumab in clinical practice.
据报道,地诺单抗可增加骨密度(BMD)并抑制骨折,但治疗反应不佳的情况并不少见。本研究旨在确定地诺单抗治疗反应不佳的风险因素。这是第一项探索地诺单抗治疗反应不佳风险因素的研究。
这项回顾性观察性研究调查了227名日本绝经后女性,她们接受了地诺单抗治疗,并每隔6个月通过双能X线吸收法监测骨密度。使用Cox比例风险模型确定风险因素。治疗反应不佳者定义为3年内骨密度较基线的变化未超过最小显著变化。
3年腰椎(LS)-BMD、股骨颈(FN)-BMD和全髋(TH)-BMD较基线的平均相对变化分别为12.6%、6.8%和6.1%。LS-BMD治疗反应不佳者有10例,FN-BMD为47例,TH-BMD为38例。治疗反应不佳的风险因素包括:LS-BMD方面为同时使用糖皮质激素;FN-BMD方面为低体重指数或在较高骨密度时开始治疗;TH-BMD方面为先期使用双膦酸盐或在较高骨密度时开始治疗。
地诺单抗疗效不足的风险因素在不同骨密度测量部位有所不同。在临床实践中选择地诺单抗时应考虑这些结果。