
Opinion|Videos|March 28, 2025
Understanding the Origins of the Boxed Warning for JAK Inhibitors
Experts discuss the FDA boxed warning for JAK inhibitors, which highlights risks such as venous thromboembolism (VTE), major adverse cardiac events (MACE), and malignancy originating from the ORAL surveillance trial. They compare these risks in the atopic dermatitis (AD) patient population with those seen in rheumatoid arthritis, noting generally lower incidences in patients with AD.
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Video content above is prompted by the following:
- Briefly discuss the FDA boxed warning for the JAK inhibitor class. How did this warning come about, and which adverse events are included?
- ORAL surveillance trial
- How do the risks for the adverse events stated in the FDA boxed warning compare with what has been observed in the AD patient population? How do these risks compare with JAK inhibitor use in rheumatoid arthritis?
- VTE risk
- MACE risk
- Malignancy risk
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