Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis
Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis
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DOI：
10.1016/j.jbspin.2021.105219
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发表时间：
2021-06-05
期刊：
影响因子：
4.2
通讯作者：
Okada, Seiji
中科院分区：
文献类型：
--
作者：
Ebina, Kosuke;Tsuboi, Hideki;Okada, Seiji
目的：探讨148例绝经后骨质疏松症患者既往治疗的影响，并确定romosozumab (ROMO) 12个月治疗反应的预测因素。方法：在这项前瞻性、观察性、多中心的研究中，由于先前治疗效果不足，将未接受治疗的患者（naive, n = 50）或先前接受过双膦酸盐（BP, n = 37）或地诺单抗（DMAb, n = 45）或特立帕肽（TPTD, n = 16）（平均年龄75.0岁，腰椎t评分[LS] -3.2，全髋关节[TH] -2.6）切换为ROMO。随访12个月，测定骨密度（BMD）和血清骨转换指标。结果：12个月时，LS BMD变化为Naive（18.2%）、BP（10.2%）、DMAb（6.4%）、TPTD(11.2%)（组间P < 0.001）； TH BMD变化为Naive（5.6%）、BP（3.3%）、DMAb（0.6%）、TPTD(4.4%)（组间P < 0.01）。在所有组中，在6个月和12个月时，LS骨密度从基线显著增加，尽管只有DMAb组在12个月的治疗期间未能获得TH骨密度的显著增加。从基线-> 1个月-> 12个月，n端I型前胶原前肽（PINP; mu g/L）的平均值为Naive (67.9 -> 134.1 -> 51.0)， BP(32。2 -> 81.7 -> 40.9), DMAb (30.4 -> 56.2 -> 75.3)， TPTD(97.4 -> 105.1 -> 37.1)，以及抗酒石酸酸性磷酸酶（TRACP-5b; mU/dL）的异构体5b分别为Naive (500.4 -> 283.8 -> 267.1), BP (273.4 -> 203.1 -> 242.0), DMAb (220.3 -> 246.1 -> 304.8)， TPTD（446.6 -> 305.1 -> 235.7）。多元回归分析显示，LS患者12个月BMD变化的显著预测因子为既往治疗差异（r = -2.8, P < 0.001）和1个月PINP值（r = 0.04, P < 0.01）， TH患者12个月BMD变化的显著预测因子为既往治疗差异（r = -1.3, P < 0.05）和1个月TRACP-5b百分比变化（r = -0.06, P < 0.05）。结论：ROMO对12个月时LS和TH BMD升高的早期影响受既往治疗差异的显著影响，并可通过早期骨转换标志物的变化预测。(C) 2021法国风湿病学会。Elsevier Masson SAS出版。版权所有。
Objectives: To investigate the effects of prior treatment and determine the predictors of a 12-month treatment response of romosozumab (ROMO) in 148 patients with postmenopausal osteoporosis.Methods: In this prospective, observational, and multicenter study, treatment naive patients (Naive; n = 50) or patients previously treated with bisphosphonates (BP; n = 37) or denosumab (DMAb; n = 45) or teriparatide (TPTD; n = 16) (mean age, 75.0 years; T-scores of the lumbar spine [LS] -3.2 and total hip [TH] -2.6) were switched to ROMO due to insufficient effects of prior treatment. Bone mineral density (BMD) and serum bone turnover markers were evaluated for 12 months.Results: At 12 months, changes in LS BMD were Naive (18.2%), BP (10.2%), DMAb (6.4%), and TPTD (11.2%) (P < 0.001 between groups) and changes in TH BMD were Naive (5.6%), BP (3.3%), DMAb (0.6%), and TPTD (4.4%) (P < 0.01 between groups), respectively. In all groups, the LS BMD significantly increased from baseline at 6 and 12 months, although only the DMAb group failed to obtain a significant increase in TH BMD during 12-month treatment. Mean values of N-terminal type I procollagen propeptide (PINP; mu g/L) from baseline -> 1 month -> 12 months were Naive (67.9 -> 134.1 -> 51.0), BP (32. 2 -> 81.7 -> 40.9), DMAb (30.4 -> 56.2 -> 75.3), and TPTD (97.4 -> 105.1 -> 37.1), and those of isoform 5b of tartrate-resistant acid phosphatase (TRACP-5b; mU/dL) were Naive (500.4 -> 283.8 -> 267.1), BP (273.4 -> 203.1 -> 242.0), DMAb (220.3 -> 246.1 -> 304.8), and TPTD (446.6 -> 305.1 -> 235.7), respectively. Multiple regression analysis revealed that the significant predictors of BMD change at 12 months were difference of prior treatment (r = -2.8, P < 0.001) and value of PINP at 1 month (r = 0.04, P < 0.01) for LS, and difference of prior treatment (r = -1.3, P < 0.05) and percentage change of TRACP-5b at 1 month (r = -0.06, P < 0.05) for TH.Conclusions: The early effects of ROMO on LS and TH BMD increase at 12 months were significantly affected by the difference of prior treatment and are predicted by the early change in bone turnover markers. (C) 2021 Societe francaise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.