Division of Advanced Preventive Medical Sciences, Unit of Advanced Preventive Medical Sciences, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Medical Education Development Center, Nagasaki University School Hospital, Nagasaki, Japan.
J Bone Miner Metab. 2019 May;37(3):554-562. doi: 10.1007/s00774-018-0955-7. Epub 2018 Sep 5.
We examined the efficacy and safety of denosumab as treatment for glucocorticoid-induced osteoporosis (GIOP) patients complicated with rheumatic diseases, by measuring patients' lumber bone mineral density (BMD) and bone turnover markers. A total of 66 consecutive patients for whom denosumab was initiated between July 2013 and August 2016 were enrolled and evaluated for 12 months. All of the patients were treated with glucocorticoids for underlying rheumatic diseases. The clinical assessment included measurements of the BMD of the lumbar spine (L2-L4) by a dual-energy X-ray absorptiometry technique and the bone turnover markers N-terminal telopeptide of type 1 collagen (NTX) in urine, serum intact procollagen type 1 N-terminal propeptide (P1NP), and bone-specific alkaline phosphatase (BAP) at baseline, 6 months and 12 months after the start of denosumab treatment. Adverse events (AEs) until 12 months were also analyzed. The mean percentage changes in BMD from baseline to 6 and 12 months were significant (2.85% increase, p < 0.0001 and 4.40% increase, p < 0.0001, respectively) regardless of the prior anti-osteoporotic drugs treatment (16 no transition from anti-osteoporotic drugs, 27 transition from bisphosphonate, 23 transition from teriparatide). The decreases in NTX, P1NP and BAP at 6 and 12 months were also significant. No serious AEs were noted. A multivariable logistic analysis showed that the prednisolone dose at baseline was associated with the clinical response to denosumab. In a real-world setting, denosumab was effective and safe for treating GIOP patients complicated with rheumatic diseases regardless of prior anti-osteoporotic drug treatment.
我们通过测量患者腰椎骨密度（BMD）和骨转换标志物来研究地舒单抗治疗合并风湿性疾病的糖皮质激素诱导骨质疏松症（GIOP）患者的疗效和安全性。共纳入 66 例 2013 年 7 月至 2016 年 8 月期间接受地舒单抗治疗的患者，对其进行为期 12 个月的评估。所有患者均因基础风湿性疾病而接受糖皮质激素治疗。临床评估包括双能 X 线吸收法测量腰椎（L2-L4）BMD，以及在基线、地舒单抗治疗开始后 6 个月和 12 个月时尿 N 端肽型胶原（NTX）、血清完整型前胶原 1 N 端前肽（P1NP）和骨碱性磷酸酶（BAP）等骨转换标志物。同时还分析了 12 个月内的不良事件（AE）。无论是否使用过抗骨质疏松药物（16 例未从抗骨质疏松药物转换，27 例从双磷酸盐转换，23 例从特立帕肽转换），从基线到 6 个月和 12 个月时 BMD 的平均百分比变化均具有统计学意义（分别增加 2.85%，p<0.0001 和 4.40%，p<0.0001）。6 个月和 12 个月时 NTX、P1NP 和 BAP 的降低也具有统计学意义。未观察到严重 AE。多变量逻辑分析显示，基线时泼尼松剂量与对地舒单抗的临床反应相关。在真实世界环境中，地舒单抗治疗合并风湿性疾病的 GIOP 患者无论是否使用过抗骨质疏松药物均有效且安全。
