A high level of clinical response based on composite indices is associated with improved health-related quality of life: Analyses from a phase 3 clinical trial in patients with rheumatoid arthritis

Background: Rheumatoid arthritis (RA) is a chronic disease associated with inflammatory activity and joint damage that result in disability, pain, and other impairments. The current recommendation is to assess disease activity based on composite indices with objective signs of inflammation (e.g. synovitis, acute phase reactants) and patient's assessment of disease activity. The patient's perception of disease impact and its treatment also facilitate shared decision-making about treatment. Objectives: To compare patient-reported outcomes (PROs) for RA patients who achieved low disease activity (LDA) or remission based upon the DAS28-ESR compared to those with moderate and high disease activity (MDA and HDA) in this post-hoc analysis of a randomized, double-blind phase 3 clinical trial, RA-BEAM1. Methods: 1305 patients were randomized to placebo (N=488), adalimumab (N=330) or baricitinib 4 mg (N=487). Patients with observed DAS28-ESR values at Week 24 (N=1,010) were divided into 4 disease activity groups: HDA (DAS28-ESR>5.1), MDA (3.220. Sensitivity analyses using other clinical measures (DAS28-CRP, SDAI, CDAI) to define disease activity confirmed the findings. Conclusions: Improving patient disease activity is associated with improved health-related quality of life. Patients who achieved remission had greater improvement in PROs but residual pain remained. Further research is needed to understand the treatment differences in the association between disease activity and PROs among different therapies.