Comparative Safety of JAK Inhibitors vs TNF Antagonists in Immune-Mediated Inflammatory Diseases

What are the comparative safety profiles of Janus kinase (JAK) inhibitors vs tumor necrosis factor (TNF) antagonists in patients with immune-mediated inflammatory diseases (IMIDs)?In this systematic review and meta-analysis including 42 head-to-head comparative effectiveness studies of 813 881 patients with IMIDs treated with JAK inhibitors or TNF antagonists, no meaningful differences in risk of serious infections, malignant neoplasms, and major cardiovascular events were observed. JAK inhibitor use was associated with a slightly higher risk of venous thromboembolism compared with TNF antagonist use; the overall incidence of serious adverse events was low.These findings call for revisiting the strict regulatory guidance imposed by the US Food and Drug Administration and the European Medicines Agency restricting use of all JAK inhibitors after failure of, or contraindications to, TNF antagonists, across all indications.

Corresponding Author: Siddharth Singh, MD, MS, Divisions of Gastroenterology and Biomedical Informatics, Department of Medicine, UCSD IBD Center, University of California San Diego, 9452 Medical Center Dr, ACTRI 1W501, La Jolla, CA 92037 (sis040@ucsd.edu).

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