Opinion
Video
Boxed Warnings for JAK Inhibitors in AD
Author(s):
Alexandra Golant, MD, comments on the boxed warnings on all currently approved JAK inhibitors, as well as the commonly used treatments in dermatology that have boxed warnings.
This is a video synopsis/summary of a panel discussion involving Christopher Bunick, MD, PhD; Peter Lio, MD; Lisa Swanson, MD, PhD; and Alexandra Golant, MD.
The FDA has introduced a new boxed warning for all currently approved Janus kinase (JAK) inhibitors, including a topical drug, used in the treatment of arthritis and inflammatory conditions. This decision follows findings from the oral surveillance study, which compared tofacitinib with tumor necrosis factor alpha inhibitors in rheumatoid arthritis patients aged 50 and older with at least 1 cardiovascular risk factor. Dr Golant explains that the study involved an extremely immunosuppressed population, which may not be representative of the dermatology patient population.
The boxed warning for JAK inhibitors resulted from the study's failure to meet non-inferiority criteria, leading to concerns about cardiovascular events, mortality, serious infections, malignancy, and thromboembolic events. Dr. Swanson emphasizes the importance of counseling dermatology patients effectively, considering the differences in the study population and the medications specifically designed for dermatological conditions.
Dr Lio adds perspective, stating that a boxed warning does not necessarily mean avoiding the drug's use. He draws parallels with other commonly used medications in dermatology, such as topical tacrolimus and biologics, which also carry boxed warnings. The conversation extends to Dr Swanson's study comparing JAK inhibitors with traditional systemic immunosuppressants like methotrexate and corticosteroids. The study revealed higher risk factors for the latter, prompting Dr Lio to advocate for reconsidering the use of systemic corticosteroids in atopic dermatitis patients.
Dr Lio also praises Dr. Swanson's research for comparing risk factors across different treatments, emphasizing the need for long-term data to continue reassuring clinicians about the safety of JAK inhibitors. Dr Swanson acknowledges the ongoing "JAK journey" and stresses the importance of obtaining more data over time.
In conclusion, the physicians encourage embracing the boxed warning, emphasizing the powerful impact of JAK inhibitors on changing patients' lives. They advocate for thorough yet efficient communication with patients, considering individual medical histories and candidacy for these therapies. Overall, they express confidence in the continued integration and acceptance of JAK inhibitors in dermatological practice.
Video synopsis is AI-generated and reviewed by HCPLive editorial staff.
