JAK-Inhibitors – A Story of Success and Adverse Events

Abstract

Rebekka Wlassits,1 Mathias Müller,2 Karl H Fenzl,1 Thomas Lamprecht,3 Ludwig Erlacher3 1Karl Landsteiner Institut für Autoimmunerkrankungen und Rheumatologie, Vienna, Austria; 2Department für Biomedizinische Wissenschaften, Institut für Tierzucht und Genetik, Veterinärmedizinische Universität Wien, Vienna, Austria; 3Ludwig Erlacher, Karl Landsteiner Institut für Autoimmunerkrankungen und Rheumatologie, Vienna, AustriaCorrespondence: Rebekka Wlassits, Karl Landsteiner Institut für Autoimmunerkrankungen und Rheumatologie, Vienna, Kundratstraße 3, 1100 Wien, Austria, Tel [phone], Email [email protected]: Rheumatoid arthritis (RA) is a systemic, chronic, immune-mediated inflammatory condition. Treatments options encompass conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic disease-modifying antirheumatic drugs (bDMARDs) like tumor necrosis factor (TNF) inhibitors (TNFis) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) including Janus Kinase inhibitors (JAKinibs). Orally administered JAKinibs have demonstrated comparable or, in specific cases, superior efficacy compared to bDMARDs in inflammatory conditions. However, the escalating clinical utilization has been accompanied by the emergence of serious adverse effects, including major adverse cardiac events (MACE), malignancies and venous thrombotic episodes (VTE), leading to regulatory restrictions imposed by health authorities in both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).Keywords: rheumatoid arthritis, treatment, safety restrictions, major adverse cardiac events, malignancies, venous thrombotic episodes

Keywords

• rheumatoid arthritis
• treatment
• safety restrictions
• major adverse cardiac events
• malignancies
• venous thrombotic episodes