Kojima Masayo, Kawahito Yutaka, Sugihara Takahiko, Kojima Toshihisa, Harada Ryozo, Hirata Shintaro, Hashimoto Motomu, Hidaka Toshihiko, Ishikawa Hajime, Ito Hiromu, Kishimoto Mitsumasa, Kaneko Yuko, Matsui Kazuo, Matsui Toshihiro, Matsushita Isao, Morinobu Akio, Nishida Keiichiro, Tanaka Eiichi, Abe Asami, Ishitoku Michinori, Asai Shuji, Kida Takashi, Onishi Akira, Takanashi Satoshi, Harigai Masayoshi
Nagoya City University, Kawasumi1, Mizuho, Nagoya, Aichi, 466-8601, Japan.
National Center for Geriatrics and Gerontology, 7-430, Morioka-Cho, Obu City, Aichi, 474-8511, Japan.
BMC Rheumatol. 2022 Dec 26;6(1):90. doi: 10.1186/s41927-022-00322-7.
Although drug treatment strategies for rheumatoid arthritis (RA) are relatively well established, there is a paucity of evidence on the treatment in older patients. The purpose of this study is to build a registry for late-onset RA (LORA), which is expected to increase rapidly worldwide. In addition, we aim to propose optimal treatment strategies according to the patient background including frailty, thereby contributing to improving the quality of treatment and daily living in patients with RA.
METHODS/DESIGN: The LORIS (Late-onset Rheumatoid Arthritis Registry) Study is a prospective nation-wide multicenter observational study of patients with LORA. The inclusion criteria were patients aged ≥ 65 years at onset, meeting 2010 ACR/EULAR classification criteria for RA, and starting either any disease-modifying antirheumatic drugs (DMARDs) in a DMARD-naïve patient or the first biologic/targeted synthetic DMARDs during the study period. Enrollment was started on 11 January, 2022 and will be closed on 31 December, 2023. Patients will undergo a comprehensive baseline assessment including clinical data, medication, cognitive and physical function, psychosocial factors, and frailty. Data will be collected at baseline, Month 3, 6, 12, 18, 24, 36, and summarized descriptively. The factors associated with adverse events and achieving remission will be determined.
A multi-disciplinary panel including patients, rheumatologists, and geriatric specialists will discuss the results and build a consensus regarding the treatment goals of LORA. We expect to provide a broad range of information for evidence-based shared decision making in the treatment of LORA.
Registered at the UMIN registry (UMIN000046086) on 1 January 2022.
尽管类风湿关节炎（RA）的药物治疗策略相对成熟，但关于老年患者治疗的证据却很匮乏。本研究的目的是建立一个迟发性类风湿关节炎（LORA）登记系统，预计该疾病在全球范围内将迅速增加。此外，我们旨在根据包括虚弱在内的患者背景提出最佳治疗策略，从而有助于提高RA患者的治疗质量和日常生活质量。
方法/设计：LORIS（迟发性类风湿关节炎登记）研究是一项针对LORA患者的前瞻性全国多中心观察性研究。纳入标准为发病年龄≥65岁、符合2010年美国风湿病学会（ACR）/欧洲抗风湿病联盟（EULAR）RA分类标准，且在未使用过改善病情抗风湿药物（DMARDs）的患者中开始使用任何DMARDs，或在研究期间开始使用第一种生物制剂/靶向合成DMARDs。招募工作于2022年1月11日开始，将于2023年12月31日结束。患者将接受全面的基线评估，包括临床数据、用药情况、认知和身体功能、心理社会因素以及虚弱状况。数据将在基线、第3、6、12、18、24、36个月收集，并进行描述性总结。将确定与不良事件和实现缓解相关的因素。
一个由患者、风湿病学家和老年病专家组成的多学科小组将讨论研究结果，并就LORA的治疗目标达成共识。我们期望为LORA治疗中的循证共同决策提供广泛的信息。
于2022年1月1日在UMIN注册中心（UMIN000046086）注册。
