Boleto Gonçalo, Dramé Moustapha, Lambrecht Isabelle, Eschard Jean-Paul, Salmon Jean-Hugues
Rheumatology Department, Maison Blanche Hospital, Reims University Hospitals, 51092, Reims, France.
Department of Research and Innovation, Robert Debré Hospital, Reims University Hospitals, 51092, Reims, France.
Clin Rheumatol. 2017 Aug;36(8):1699-1706. doi: 10.1007/s10067-017-3722-6. Epub 2017 Jul 1.
The aim of this study was to evaluate the structural effect of denosumab on patients with rheumatoid arthritis (RA). We performed a systematic review of the literature in the following databases: PubMed, Cochrane, Web of Science, ClinicalTrials.gov , and the WHO International Clinical Trials Registry Platform. All studies evaluating the structural effect of denosumab on RA and meeting predefined criteria were included. Data regarding disease activity, progression of joint damage, joint space narrowing, and safety were recorded. Among 168 studies identified, only 4 were finally included in this review, involving a total of 687 patients. These 4 studies showed that denosumab is effective on joint damage at 6 and 12 months as compared to placebo, alendronate, and biological disease-modifying anti-rheumatic drugs (bDMARDs) alone. No effect was observed in terms of joint space narrowing, and DAS28 and HAQ scores remained unchanged. No case of osteonecrosis of the jaw or atypical fracture was recorded, and safety was similar in both denosumab and control groups. Denosumab appears to be effective on joint erosion at 6 and 12 months in patients with RA meeting the ACR criteria, treated or not by a biologic, with excellent safety.
本研究的目的是评估地诺单抗对类风湿关节炎（RA）患者的结构影响。我们在以下数据库中对文献进行了系统综述：PubMed、Cochrane、科学网、ClinicalTrials.gov以及世界卫生组织国际临床试验注册平台。纳入所有评估地诺单抗对RA的结构影响且符合预定义标准的研究。记录有关疾病活动、关节损伤进展、关节间隙变窄和安全性的数据。在检索到的168项研究中，最终仅4项被纳入本综述，共涉及687例患者。这4项研究表明，与安慰剂、阿仑膦酸盐和单独使用的生物性改善病情抗风湿药（bDMARDs）相比，地诺单抗在6个月和12个月时对关节损伤有效。在关节间隙变窄方面未观察到效果，DAS28和HAQ评分保持不变。未记录到颌骨坏死或非典型骨折病例，地诺单抗组和对照组的安全性相似。对于符合美国风湿病学会（ACR）标准、无论是否接受生物制剂治疗的RA患者，地诺单抗在6个月和12个月时似乎对关节侵蚀有效，且安全性良好。
