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Spotlight -

This Year In Medicine 2025

Opinion|Videos|March 28, 2025

Understanding the Origins of the Boxed Warning for JAK Inhibitors

Author(s)Linda Stein Gold, MD, Lisa Swanson, MD, PhD, James Song, MD

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.

Episodes in this series

EP. 1 The Role of the JAK/STAT Signaling Pathway in Atopic Dermatitis

EP. 1 The Role of the JAK/STAT Signaling Pathway in Atopic Dermatitis

EP. 2 JAK1 Selective Inhibition and the Impact of Selectivity on Efficacy and Safety

EP. 2 JAK1 Selective Inhibition and the Impact of Selectivity on Efficacy and Safety

EP. 3 Long-Term Efficacy and Safety of JAK Inhibitors in Atopic Dermatitis

EP. 3 Long-Term Efficacy and Safety of JAK Inhibitors in Atopic Dermatitis

EP. 4 Understanding the Origins of the Boxed Warning for JAK Inhibitors

EP. 4 Understanding the Origins of the Boxed Warning for JAK Inhibitors

EP. 5 Communicating With Patients on the Safety of JAK Inhibitors in Atopic Dermatitis

EP. 5 Communicating With Patients on the Safety of JAK Inhibitors in Atopic Dermatitis

EP. 6 Laboratory Monitoring Plans for Oral JAK Inhibitors

EP. 6 Laboratory Monitoring Plans for Oral JAK Inhibitors

EP. 7 Oral JAK Inhibitors’ Place in Atopic Dermatitis Guidelines

EP. 7 Oral JAK Inhibitors’ Place in Atopic Dermatitis Guidelines

EP. 8 Utilizing Patient Factors to Guide Treatment Selection in Atopic Dermatitis

EP. 8 Utilizing Patient Factors to Guide Treatment Selection in Atopic Dermatitis

EP. 9 Addressing Treatment Response and Switching Among Systemic Therapies in Atopic Dermatitis

EP. 9 Addressing Treatment Response and Switching Among Systemic Therapies in Atopic Dermatitis

EP. 10 Oral JAK Inhibitor Dose Escalation in Atopic Dermatitis Treatment

EP. 10 Oral JAK Inhibitor Dose Escalation in Atopic Dermatitis Treatment

EP. 11 Key Takeaways on the Role of Oral JAK Inhibitors in Atopic Dermatitis Management

EP. 11 Key Takeaways on the Role of Oral JAK Inhibitors in Atopic Dermatitis Management

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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