Department of Internal Medicine, Severance Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Department of Orthopedic Surgery, Inje University Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Korea.
Endocrinol Metab (Seoul). 2022 Jun;37(3):497-505. doi: 10.3803/EnM.2022.1427. Epub 2022 Jun 3.
The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice.
Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck.
Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean± standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively.
The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.
在一项针对韩国绝经后骨质疏松症女性的 3 期、随机、安慰剂对照试验中，地舒单抗的疗效和安全性得到了证实。本项上市后监测研究旨在调查地舒单抗在韩国真实临床实践中的安全性和有效性。
本研究纳入了自 2014 年 9 月至 2019 年 9 月期间，根据韩国批准的适应证接受地舒单抗治疗的骨质疏松症患者。主要终点是不良事件（AE）和药物不良反应（ADR）的发生率。次要终点是腰椎、全髋和股骨颈骨密度（BMD）相对于基线的百分比变化。
在纳入的 3221 例患者中，3185 例患者进入安全性分析集；其中 2973 例（93.3%）为女性，平均年龄±标准差（SD）为 68.9±9.9 岁。平均研究期为 350.0±71.4 天。AE、致死性 AE 和 ADR 的发生率分别为 19.3%、0.8%和 1.6%。发生率＞0.5%的最常见 AE 为头晕（0.7%）、关节痛（0.7%）、背痛（0.6%）和肌痛（0.6%）。低钙血症的发生率为 0.3%。无颌骨坏死和非典型股骨骨折病例。腰椎、全髋和股骨颈 BMD 相对于基线的平均百分比变化分别为 7.3%±23.6%、3.6%±31.4%和 3.2%±10.7%。
在本研究中，韩国骨质疏松症患者使用地舒单抗的安全性和有效性与韩国随机对照试验相当，未发现新的安全性发现。
