Effectiveness of Baricitinib Risk Minimization Activities in Patients With Rheumatoid Arthritis : A Cohort Study in Four Nordic Countries

Abstract

Introduction: Baricitinib received European Medicines Agency (EMA) approval for the treatment of moderate-to- severe active rheumatoid arthritis (RA) in 2017. Due to risks including serious infections, increased blood lipid parameters, and missing information regarding safety in pregnancy, additional risk minimization measures (aRMM) including healthcare professional educational material and a patient alert card were implemented to inform on the risks and actions to minimize risk such as the need to screen for tuberculosis and active viral hepatitis before starting baricitinib, monitoring of blood lipids and against use during pregnancy. The aim of the study is to report occurrences of infections, lipid level monitoring and pregnancies, in real world data, to gain insights into whether baricitinib is used in accordance with the aRMM. Methods: A descriptive observational cohort study, utilizing routinely collected data from the Swedish, Norwegian, Finnish, and Danish national registries, was carried out. RA patients initiating baricitinib treatment were identified in the periods 2017–19 (Sweden and Finland), 2017–20 (Norway) and 2017–21 (Denmark). Monitored events included pregnancies, cases of tuberculosis, viral hepatitis, and hyperlipidemia, as well as changes in statin prescriptions (including any of initiation, escalation, reduction or change of statin). Hyperlipidemia and statin use served as proxies for lipid level assessment. Results: Among 3908 patients initiating baricitinib (3373 person-years exposure), eight pregnancies (1% of 815 women aged 18–50 years) potentially overlapped with treatment. During baricitinib treatment, there was a small number of prevalent cases of tuberculosis (less than three events), and a low prevalence of hepatitis (0.2%), and hyperlipidemia (0.5%), whereas 9.3% had start of or changes in statin prescription, indicating lipid level monitoring.