Baricitinib retention and factors associated thereof in clinical practice: a prospective, multicenter 12-month study in rheumatoid arthritis patients.

Herein we report for baricitinib drug retention, predictors thereof and clinical responses in rheumatoid arthritis (RA) patients with a special focus in comorbidities. Prospective, multicenter, observational study of RA patients starting baricitinib because of active disease. Patients were followed every 3 months for 12 months. The primary endpoint was baricitinib retention at 12 months; predictors for survival and clinical responses at 6 months were secondary endpoints. Retention rate was estimated by Kaplan-Meier (K-M) while predictors of discontinuation by Cox regression. We recruited 135 patients, 93.3% females, mean (standard deviation-SD) age 56.1 (10.1) years, median (interquartile range) disease duration 57 (90) months. 18.5% started baricitinib as first line targeted therapy. 35.9% (28/88) and 44.1% (26/59) achieved DAS28 remission/low disease activity (LDA) at 6 and 12 months respectively. Baricitinib retention at 12 months was 68.9%. K-M analysis showed that hypertension (p=0.049), latent tuberculosis infection (LTBi) (p=0.007) and depression (p=0.005) were associated to lower retention, while multivariate analysis showed that depression [Hazard ratio (HR) 2.715, p=0.007] and LTBi (HR 2.519, p=0.020) predicted baricitinib discontinuation. Analysis for patients on therapy for at least 6 months showed that together with hypertension (HR 2.477, p=0.022) and LTBi (HR 3.761, p=0.023), higher DAS28 at 6 months (HR 1.434, p=0.024) predicted baricitinib discontinuation at 12 months. In established RA, 68.9% of the patients remained on baricitinib at 12 months and had an improvement of disease activity. Mostly comorbidities contributed to baricitinib persistence, supporting their importance as factors to be addressed to optimize RA clinical care.