Department of Orthopaedic, Xiangya Hospital, Central South University, Changsha, 410008, China.
Department of Orthopedics, General Hospital of Chinese PLA, Beijing, 100853, China.
J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3366-e3373. doi: 10.1210/clinem/dgac262.
Recent meta-analyses of randomized controlled trials have raised concerns that denosumab might increase the risk of infection. However, data of denosumab on the risk of community-acquired pneumonia are sparse.
This work aimed to examine the risk of community-acquired pneumonia in individuals receiving denosumab compared to those receiving alendronate.
We conducted a propensity score-matched cohort study with a UK primary care database (IQVIA Medical Research Database). We examined the relation of denosumab to community-acquired pneumonia using a Cox proportional hazard model. The study participants were osteoporotic patients older than 45 years who were initiators of denosumab or alendronate from August 1, 2010, to September 17, 2020. The outcome measure was community-acquired pneumonia.
Patients treated with denosumab (n = 933) were compared with those treated with alendronate (n = 4652). In the matched population, the mean (SD) age was 77 (11) years, 89% were women, and about half of the study population had a history of major osteoporotic fracture. Over 5 years of follow-up, the incidence of community-acquired pneumonia per 1000 person-years was 72.0 (95% CI, 60.1-85.7) in the denosumab group and 75.1 (95% CI, 69.4-81.2) in the alendronate group. The hazard of community-acquired pneumonia was similar between denosumab and alendronate users (hazard ratio [HR] 0.96; 95% CI, 0.79-1.16). The results remained consistent in a series of sensitivity analyses, with HR ranging from 0.82 (95% CI, 0.65-1.04) to 0.99 (95% CI, 0.81-1.21).
Denosumab does not significantly increase the susceptibility of community-acquired pneumonia and could possibly be safely used for the management of osteoporosis.
最近的几项随机对照试验的荟萃分析引起了人们的担忧，即地舒单抗可能会增加感染的风险。然而，关于地舒单抗导致社区获得性肺炎风险的数据很少。
本研究旨在检查与使用阿仑膦酸钠相比，接受地舒单抗治疗的个体发生社区获得性肺炎的风险。
我们使用英国初级保健数据库（IQVIA Medical Research Database）进行了一项倾向评分匹配的队列研究。我们使用 Cox 比例风险模型检查地舒单抗与社区获得性肺炎的关系。研究参与者为年龄大于 45 岁的骨质疏松症患者，他们于 2010 年 8 月 1 日至 2020 年 9 月 17 日开始接受地舒单抗或阿仑膦酸钠治疗。结局指标为社区获得性肺炎。
地舒单抗治疗组（n=933）与阿仑膦酸钠治疗组（n=4652）进行比较。在匹配人群中，平均（SD）年龄为 77（11）岁，89%为女性，约一半的研究人群有主要骨质疏松性骨折史。在 5 年的随访期间，地舒单抗组和阿仑膦酸钠组每 1000 人年的社区获得性肺炎发生率分别为 72.0（95%CI，60.1-85.7）和 75.1（95%CI，69.4-81.2）。地舒单抗和阿仑膦酸钠使用者发生社区获得性肺炎的风险相似（风险比[HR]0.96；95%CI，0.79-1.16）。在一系列敏感性分析中，结果保持一致，HR 范围为 0.82（95%CI，0.65-1.04）至 0.99（95%CI，0.81-1.21）。
地舒单抗不会显著增加社区获得性肺炎的易感性，可能可安全用于骨质疏松症的治疗。
