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Late-onset rheumatoid arthritis registry study, LORIS study: study protocol and design.
Masayo Kojima1,2, Yutaka Kawahito3, Takahiko Sugihara4
1Nagoya City University, Kawasumi1, Mizuho, Nagoya, Aichi, 466-8601, Japan. masayok@med.nagoya-cu.ac.jp.
This study establishes a registry for late-onset rheumatoid arthritis (LORA) in patients 65 years and older. It aims to develop optimal treatment strategies, considering factors like frailty, to improve care for this growing population.
Area of Science:
- Rheumatology
- Geriatrics
- Clinical Research
Background:
- Limited evidence exists for treating rheumatoid arthritis (RA) in older adults.
- Late-onset rheumatoid arthritis (LORA) is a growing global health concern.
- Existing RA treatment guidelines lack specific recommendations for elderly patients.
Purpose of the Study:
- To establish a comprehensive registry for late-onset RA (LORA) patients.
- To investigate optimal treatment strategies tailored to patient background, including frailty.
- To enhance treatment quality and daily living for LORA patients.
Main Methods:
- Prospective, nationwide, multicenter observational study (LORIS).
- Inclusion criteria: age ≥ 65 years at RA onset, meeting 2010 ACR/EULAR criteria, initiating DMARDs or first biologic/targeted synthetic DMARDs.
- Comprehensive baseline assessment (clinical data, function, psychosocial factors, frailty) with follow-up at 3, 6, 12, 24, and 36 months.
Main Results:
- Data collection ongoing from January 2022 to December 2023.
- Analysis will focus on factors associated with adverse events and remission achievement.
- Descriptive summarization of collected data.
Conclusions:
- A multidisciplinary panel (patients, rheumatologists, geriatric specialists) will discuss findings.
- Consensus will be built regarding treatment goals for LORA.
- The study aims to provide evidence for shared decision-making in LORA treatment.
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