Sugimoto Toshitsugu, Yoshimura Takeshi, Uzawa Toyonobu
Eikokai Ono Hospital, Hyogo, Japan.
Medical Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Osteoporos Sarcopenia. 2021 Mar;7(1):11-16. doi: 10.1016/j.afos.2020.12.001. Epub 2021 Jan 7.
To assess differences in efficacy of a 28.2-μg teriparatide formulation for twice-weekly use (2/W-TPTD) by patient characteristics.
A analysis was performed using data from a multicenter, randomized, double-blind, double-dummy, non-inferiority trial (TWICE study) conducted in Japan comparing the efficacies of once-weekly and twice-weekly injections of teriparatide (TPTD). Specifically, a stratified analysis of percentage changes from baseline was performed using the final data on lumbar spine bone mineral density (BMD) after a 48-week treatment period (n = 251, 2/W-TPTD; n = 239, a 56.5-μg teriparatide formulation for once-weekly use [1/W-TPTD]).
Across all subgroups defined by patient characteristics that included 9 or more subjects, the lumbar spine BMD increased significantly in both groups. In the 2/W-TPTD group, the percentage change was significantly higher in subjects with no non-vertebral fractures without large external force occurring at or after age 50 years versus those with such fractures. The lower the stratification in baseline lumbar spine BMD, total hip BMD, or femoral neck BMD, the greater was the percentage change.
Whereas all subgroups can expect a significant improvement in lumbar spine BMD, there were some patient characteristics that affected the percentage increase in BMD.
根据患者特征评估每周两次使用的28.2μg特立帕肽制剂（2/W-TPTD）的疗效差异。
使用在日本进行的一项多中心、随机、双盲、双模拟、非劣效性试验（TWICE研究）的数据进行分析，比较每周一次和每周两次注射特立帕肽（TPTD）的疗效。具体而言，使用48周治疗期后腰椎骨密度（BMD）的最终数据（n = 251，2/W-TPTD；n = 239，每周一次使用的56.5μg特立帕肽制剂[1/W-TPTD]）对基线百分比变化进行分层分析。
在由9名或更多受试者组成的所有根据患者特征定义的亚组中，两组的腰椎BMD均显著增加。在2/W-TPTD组中，50岁及以后未发生无大外力作用下非椎体骨折的受试者的百分比变化显著高于有此类骨折的受试者。基线腰椎BMD、全髋BMD或股骨颈BMD的分层越低，百分比变化越大。
虽然所有亚组的腰椎BMD都有望显著改善，但有些患者特征会影响BMD的百分比增加。
