OBJECTIVES: Clinical studies are underway to support development of SAR441566, a tumor necrosis factor receptor 1 inhibitor as a treatment for Rheumatoid Arthritis (RA) (NCT06073093). This study aimed to build conceptual models depicting meaningful aspects of health (MAH), which are disease aspects that patients don’t want to become worse, want to improve or want to prevent, and how patients relate these to measurable outcomes to inform clinical trial design and endpoints for this and future RA trials.

METHODS: A literature search was conducted in November 2023 to identify peer-reviewed qualitative studies describing the experience of RA from the patient perspective. Patient descriptions of symptoms and impacts of RA, perceived associations between concepts, and unmet treatment needs were extracted. Conceptual models were drafted in line with the Digital Medicine Society (DiMe) framework to develop digital health endpoints. The models had expert rheumatologist input drawing from their experience of working with patients.

RESULTS: The search yielded 26 articles. The initial models detail the signs/symptoms of RA (joint pain, inflammation, warmth, stiffness, swelling, redness and deformity, and tingling, fatigue, muscle weakness, dryness and skin symptoms), impact on physical functioning, daily activities, sleep, work, cognition, social life, sexual function, psychological and emotional function and finances. Unmet treatment needs included symptom management, better treatment attributes and improvement of impacts. Although not frequently reported, potential MAH and perceived associations between concepts were identified. The rheumatologists provided context to patient report and proposed further links that patients may make between outcomes, concepts of interest, and MAH.

CONCLUSIONS: The models hypothesize how patients link signs and symptoms to impacts on patients’ daily life and what is meaningful to achieve with treatment. Patients will be interviewed in 2024 to better understand their MAH to inform the models and select patient-informed trial PROs and digital endpoints that are of clinical relevance to RA patients.