Real-World Outcomes of Baricitinib in Patients with Rheumatoid Arthritis: A Two-Year Observational Study of Overall and Difficult-to-Treat Patients in Japan.
TL;DR
Baricitinib showed sustained effectiveness and retention, including in patients with D2T RA; early improvements in pain and fatigue were predictive of CDAI disease remission during the 24-month follow-up.
Abstract
Objectives
This study aimed to evaluate real-world effectiveness and long-term retention of baricitinib in Japanese patients with rheumatoid arthritis (RA), including those classified as difficult-to-treat (D2T).
Methods
This 24-month observational study enrolled patients initiating baricitinib, stratified by prior use of biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) and baseline Clinical Disease Activity Index (CDAI) scores. Key endpoints included time-to-discontinuation, achievement of and time to low disease activity (LDA) or remission. Data were analysed using logistic regression models adjusted for demographic and clinical variables.
Results
Baricitinib demonstrated sustained effectiveness, with 58.2% of overall patients (N=353) and 42.0% of patients with D2T RA (N=88) remaining on treatment at 24 months. CDAI remission was achieved in 36.4% of overall patients and 22.9% patients with D2T RA. Discontinuation was mainly due to primary non-response (11.0%). Mean (SD) changes in patient-reported outcomes (PROs) from baseline scores were: patient global assessment of disease activity (-21.7 [28.4] mm), Health Assessment Questionnaire-Disability Index (-0.360 [0.601]), and pain visual analogue scale (-24.9 [26.8] mm). Among baseline glucocorticoid users retained on baricitinib at 24 months, 55.9% discontinued glucocorticoids.
Conclusion
Baricitinib showed sustained effectiveness and retention, including in patients with D2T RA; early improvements in pain and fatigue were predictive of CDAI disease remission during the 24-month follow-up.