Safety and effectiveness of denosumab in Japanese patients with rheumatoid arthritis: A 2-year post-marketing surveillance study.

IF 1.8 4区医学 Q3 RHEUMATOLOGY

Modern Rheumatology Pub Date : 2024-08-20 DOI:10.1093/mr/road108

Yoshiya Tanaka, Hideki Mizutani, Kunimitsu Fujii, Naoki Okubo

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引用次数: 0

Abstract

Objectives: To investigate the 2 year safety and effectiveness of denosumab 60 mg in patients with rheumatoid arthritis (RA) in clinical practice in Japan.

Methods: This 2 year, prospective, observational cohort study included patients who initiated treatment with denosumab 60 mg for the progression of bone erosion associated with RA. Key endpoints were adverse drug reactions (ADRs), progression of bone erosion, and 28-joint Disease Activity Score based on C-reactive protein or erythrocyte sedimentation rate. Univariate and multivariate analyses were conducted to determine the risk factors for ADRs and the progression of bone erosion.

Results: In the safety analysis set (n = 1239), the incidence of ADRs was 3.0%; the most common ADRs were hypocalcaemia (1.2%) and osteonecrosis of jaw-related events (0.6%). A history of any drug allergy was a statistically significant risk factor associated with the occurrence of ADRs. In the effectiveness analysis set (n = 815), the incidence of progression of bone erosion was 8.7%. Steinbrocker stage and initial steroid dose were statistically significant risk factors associated with the progression of bone erosion.

Conclusion: Denosumab demonstrated safety and effectiveness over a 2 year period in RA patients without any new safety concerns.

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denosumab在日本类风湿性关节炎患者中的安全性和有效性:一项为期2年的上市后监测研究

目的:在日本的临床实践中，研究denosumab 60mg治疗类风湿性关节炎(RA)患者2年的安全性和有效性。方法:这项为期2年的前瞻性观察队列研究纳入了开始使用denosumab 60mg治疗RA相关骨侵蚀进展的患者。关键终点是药物不良反应(adr)、骨质侵蚀的进展以及基于c反应蛋白(DAS28-CRP)或红细胞沉降率(DAS28-ESR)的28关节疾病活动评分。进行单因素和多因素分析，以确定不良反应的危险因素和骨质侵蚀的进展。结果:在安全性分析集中(N=1,239)，不良反应发生率为3.0%;最常见的不良反应是低钙血症(1.2%)和颌骨骨坏死相关事件(0.6%)。任何药物过敏史都是与adr发生相关的具有统计学意义的危险因素。在疗效分析集中(N=815)，骨侵蚀进展的发生率为8.7%。Steinbrocker分期和初始类固醇剂量是与骨侵蚀进展相关的具有统计学意义的危险因素。结论:在2年的时间里，Denosumab在RA患者中显示出安全性和有效性，没有任何新的安全性问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Modern Rheumatology RHEUMATOLOGY-

CiteScore

4.90

自引率

9.10%

发文量

146

审稿时长

1.5 months

期刊介绍： Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery. Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered. Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions