Safety profile of JAK inhibitors in inflammatory or autoimmune diseases

Rev Med Interne. 2025 Jul;46(7):386-396. doi: 10.1016/j.revmed.2025.06.003. Epub 2025 Jun 24.

Abstract

Over the past decade, Janus kinase inhibitors (JAKi) have emerged as a promising treatment for inflammatory and autoimmune diseases. Concurrently, there has been increasing attention to their potential side effects, particularly infectious and cardiovascular risks. In this review, we outline the various adverse effects of these treatments and emphasize the importance of their prevention. First, we examine the risk of infection and the preventive measures through screening, vaccination, and prophylaxis. Subsequently, we explore the risk of developing malignant tumors, venous thromboembolism, and major cardiovascular events. Although the data are sometimes inconsistent, they indicate the existence of a subpopulation at increased risk of JAKi side effects, including patients over 65years of age, those with cardiovascular and malignancy risk factors, and smokers. Finally, we discuss the risk and prevention strategies for gastrointestinal perforation, as well as the risk of biological abnormalities, such as cytopenias, cytolysis, dyslipidemia, and elevated CPK levels.

Keywords: Autoimmune diseases; JAK inhibitors; JAKi; Maladie auto-immune; Maladie systémique; Safety; Systemic diseases; Sécurité; Tolerance; Tolérance.

Publication types

  • Review

MeSH terms

  • Autoimmune Diseases* / drug therapy
  • Autoimmune Diseases* / epidemiology
  • Cardiovascular Diseases / chemically induced
  • Cardiovascular Diseases / epidemiology
  • Humans
  • Inflammation* / drug therapy
  • Inflammation* / epidemiology
  • Janus Kinase Inhibitors* / adverse effects
  • Janus Kinase Inhibitors* / therapeutic use
  • Risk Factors

Substances

  • Janus Kinase Inhibitors