Improving Clinical Management and Patient-Reported Outcomes Among Patients with Rheumatoid Arthritis in China via Real-world Evidence (IMPROVE Study): A Multicenter Prospective Cohort Study

Introduction: Patient-reported outcomes (PROs) help to understand rheumatoid arthritis (RA) from patients' perspective and play an important role in RA management. This study aims to describe the PRO changes over 6 months among patients with RA in China and explore the relationships between PROs and RA disease activity. Methods: This multicenter prospective cohort study enrolled patients with RA aged >= 18 years. At enrollment, patients were dichotomized into remission/low disease activity (LDA) and moderate-to-high disease activity (MDA/HDA) based on Disease Activity Score-28 with C-Reactive Protein (DAS28-CRP). Only patients with MDA/HDA (DAS28-CRP >= 3.2) were followed for 6 months. PROs included pain, fatigue, morning stiffness, Patients' Global Assessment (PtGA), disability, work productivity, and activity impairment. Disease activity measures included DAS28-CRP, DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI). Results: A total of 872 patients were enrolled: 520 patients in remission/LDA and 352 in MDA/HDA. In MDA/HDA patients, pain decreased significantly from enrollment at month 1 (p < 0.0001), month 3 (p < 0.0001), and month 6 (p = 0.0094). Fatigue improved significantly at month 3 (p = 0.0073). Other PROs, including morning stiffness, PtGA, disability, work productivity, and activity impairment, also improved. Patients who achieved remission/LDA had significant faster decline in pain, fatigue, PtGA, and work productivity compared to those who did not. Pain was positively correlated with disease activity measures at months 1, 3, and 6, while fatigue was positively associated with disease activity measures at months 3 and 6 only. Morning stiffness, PtGA, and disability correlated with disease activity at months 1 and 3. Conclusions: Patients with RA with MDA/HDA in China experienced significant improvement in pain and fatigue over 6 months. Improvement in DAS28-CRP was associated with faster improvement in certain PROs. While disease activity correlated with some PROs, they did not fully capture patient experience, highlighting the importance of PROs in RA management.