Late-onset rheumatoid arthritis registry study, LORIS study: study protocol and design.
Late-onset rheumatoid arthritis registry study, LORIS study: study protocol and design.
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晚发性类风湿关节炎注册研究，洛里斯研究：研究方案和设计。
DOI：
10.1186/s41927-022-00322-7
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发表时间：
2022-12-26
期刊：
影响因子：
2.2
通讯作者：
Harigai, Masayoshi
中科院分区：
文献类型：
--
作者：
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
虽然类风湿性关节炎（RA）的药物治疗策略相对完善，但在老年患者中的治疗证据不足。本研究的目的是建立一个迟发性类风湿关节炎（LORA）的登记，预计这将在世界范围内迅速增加。此外，我们的目标是根据患者的背景，包括虚弱，提出最佳的治疗策略，从而有助于提高RA患者的治疗质量和日常生活。洛里斯（迟发性风湿性关节炎登记）研究是一项针对LORA患者的前瞻性全国性多中心观察性研究。入选标准为发病时年龄≥ 65岁，符合2010年ACR/EULAR RA分类标准，并在研究期间开始在DMARD初治患者中使用任何缓解疾病的抗风湿药物（DMARD）或首次使用生物/靶向合成DMARD的患者。入组于2022年1月11日开始，并将于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、药物、认知和身体功能、心理社会因素和虚弱。将在基线、第3、6、12、18、24、36个月收集数据，并进行连续总结。将确定与不良事件和达到缓解相关的因素。 包括患者、风湿病学家和老年病专家在内的多学科小组将讨论结果，并就LORA的治疗目标达成共识。我们期望为LORA治疗中的循证共享决策提供广泛的信息。研究登记：于2022年1月1日在UMIN登记中心（UMIN 000046086）登记。在线版本包含补充材料，可通过10.1186/s41927-022-00322-7获取。
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. 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. Study registration: Registered at the UMIN registry (UMIN000046086) on 1 January 2022. The online version contains supplementary material available at 10.1186/s41927-022-00322-7.
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