Efficacy, retention, and safety of baricitinib in real-life: HUR-BIO monocentric experience

Objective: This study evaluates the effectiveness, retention rate and safety of baricitinib, including a comparison between baricitinib and a tumour necrosis factor inhibitor (adalimumab) in a real-life cohort of patients with rheumatoid arthritis (RA). Methods: RA patients from the Hacettepe University Biological Prospective Database who received at least one dose of baricitinib or adalimumab between June 2020 and January 2023 were analyzed. Drug survival analysis included patients with at least one dose, while efficacy and safety analyses required at least one follow-up visit. Adverse events, major adverse cardiovascular events (MACE), malignancies, and medication adherence were assessed. The European Alliance of Associations for Rheumatology (EULAR) response classified patients as either good responders or non-responders. Results: A total of 280 patients (86 baricitinib, 194 adalimumab) were included, with a mean age of 52.4 (±13.6) years; 77.5% were female. Baricitinib significantly improved disease activity parameters. High patient global assessment [odds ratio (OR): 1.05 (95% confidence interval (CI): 1.02-1.09)] predicted a good response, while RF positivity [OR: 7.66 (95% CI: 1.46-40.07)] indicated a poor response. MACE occurred in 2 patients (2.5%) on baricitinib and in 4 patients (2.5%) on adalimumab, with rates of 15.3 and 9.1 per 1000 patient-years, respectively (p=0.20). Conclusion: Baricitinib improved disease activity parameters and a high patient global assessment predicted a good EULAR response. MACE incidence was comparable to that with adalimumab.