Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.
Department of Pathology, Queen Elizabeth Hospital, London, UK.
J Intern Med. 2024 Dec;296(6):481-494. doi: 10.1111/joim.20017. Epub 2024 Oct 10.
To compare the efficacy of romosozumab (ROMO) and denosumab (DEN) in prevalent long-term glucocorticoid (GC) users.
Adult patients receiving oral prednisolone (≥5 mg/day) with high risk of fracture were randomized to receive subcutaneous ROMO (210 mg monthly) or DEN (60 mg 6-monthly) for 12 months, followed by DEN for two more doses. The primary end point was the change in spine bone mineral density (BMD) from Months 0 to 12. Secondary end points included changes in BMD of the spine/hip/femoral neck and bone turnover markers at various time points and adverse events.
Seventy patients (age 62.6 ± 9.1 years; 96% women; median prednisolone dose 5.0 mg/day; duration of therapy 10.7 ± 7.4 years) were enrolled, and 63 completed the study. At Month 12, the spine BMD increased significantly in both ROMO (+7.3% ± 4.5%; p < 0.001) and DEN (+2.3% ± 3.1%; p < 0.001) groups. The absolute spine BMD gain from Months 0 to 12 was significantly greater in ROMO-treated patients (p < 0.001). Although the total hip BMD at Month 12 also increased significantly in the ROMO (+1.6% ± 3.3%; p = 0.01) and DEN groups (+1.6% ± 2.6%; p = 0.003), the absolute BMD gain was not significantly different between the groups. At Month 24, the spine BMD continued to increase in both the ROMO (+9.7% ± 4.8%; p < 0.001) and DEN group (+3.0% ± 3.0%; p < 0.001) compared to baseline, and the absolute BMD gain remained significantly greater in ROMO-treated patients. The total hip BMD continued to increase in both groups (ROMO +2.9% ± 3.7%; p < 0.001; DEN +2.2% ± 3.4%; p = 0.001), but the changes from baseline were similar. Injection site reaction was more frequently reported in ROMO-treated patients.
ROMO was superior to DEN in raising the spine BMD at Month 12 in chronic GC users. After switching to DEN, ROMO-treated patients continued to gain spine BMD to a greater extent than DEN until Month 24.
比较罗莫珠单抗（ROMO）和地舒单抗（DEN）在长期使用糖皮质激素（GC）的患者中的疗效。
接受高骨折风险的口服泼尼松龙（≥5mg/天）的成年患者被随机分配接受皮下 ROMO（每月 210mg）或 DEN（每 6 个月 60mg）治疗 12 个月，然后再接受两次 DEN 治疗。主要终点是从第 0 个月到第 12 个月脊柱骨密度（BMD）的变化。次要终点包括不同时间点脊柱/髋部/股骨颈 BMD 的变化和骨转换标志物以及不良事件。
共纳入 70 例（年龄 62.6±9.1 岁；96%为女性；中位泼尼松龙剂量 5.0mg/天；治疗时间 10.7±7.4 年）患者，其中 63 例完成了研究。在第 12 个月时，ROMO（+7.3%±4.5%；p<0.001）和 DEN（+2.3%±3.1%；p<0.001）组的脊柱 BMD 均显著增加。ROMO 治疗患者从第 0 个月到第 12 个月的脊柱 BMD 绝对增加量显著更大（p<0.001）。虽然第 12 个月时 ROMO（+1.6%±3.3%；p=0.01）和 DEN 组（+1.6%±2.6%；p=0.003）的全髋 BMD 也显著增加，但两组间的绝对 BMD 增加量无显著差异。第 24 个月时，与基线相比，ROMO（+9.7%±4.8%；p<0.001）和 DEN 组（+3.0%±3.0%；p<0.001）的脊柱 BMD 继续增加，ROMO 治疗患者的 BMD 绝对增加量仍显著更大。两组的全髋 BMD 均继续增加（ROMO +2.9%±3.7%；p<0.001；DEN +2.2%±3.4%；p=0.001），但与基线相比的变化相似。ROMO 治疗患者更常报告注射部位反应。
在慢性 GC 使用者中，ROMO 在第 12 个月时提高脊柱 BMD 的效果优于 DEN。转为 DEN 治疗后，ROMO 治疗患者继续增加脊柱 BMD 的幅度大于 DEN 治疗，直至第 24 个月。
