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Key Takeaways on JAK Inhibitors and Black Box Warnings, With Eingun James Song, MD
Song speaks about JAK inhibitors and their safety in dermatology care settings, contextualizing previous data on adverse events.
Eingun James Song, MD, spoke in an interview with HCPLive about dermatologists’ evolving understanding of Janus kinase (JAK) inhibitors at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver.1
Song, director of clinical research for Frontier Dermatology, emphasized the value of contextualizing safety data and interpreting boxed warnings with an increasing level of nuance. JAK inhibitors, Song noted, have generated significant discussion in recent years, largely given various concerns surrounding safety signals identified in clinical research.
“I think it really comes down to understanding trial designs and the population that are being studied, because whenever you look at clinical data, you have to understand what population or what type of patients were in the study,” Song explained.
In his discussion, Song described boxed warnings, while important, as not unique to JAK inhibitors. He stated they should not be interpreted as definitive indicators of risk across all patient populations. Instead, clinicians should normalize their existence and focus on individualized assessments of risk. Many safety concerns linked with JAK inhibitors, including major adverse cardiovascular events (MACE), were identified in trials involving older, comorbid populations, such as those with rheumatoid arthritis.
Such individuals will likely have a higher baseline risk of adverse events (AEs) independent of JAK use, complicating direct comparisons to dermatologic patient populations. Song additionally highlighted limitations in key studies related to JAK inhibitor therapies. Importantly, he noted, real-world data in dermatologic conditions such as atopic dermatitis and alopecia areata have not demonstrated a consistent rise in AEs among those treated with JAK inhibitors when matched for demographic and clinical risk factors.
“In other words, what I tell a patient is that if you have risk factors, these things are just more likely to happen to you whether or not you take the medication,” Song said. “And based on the data that we have, which admittedly isn't perfect, it doesn't seem to be appreciably higher than what [you] have.”
Emerging data from other indications, including hidradenitis suppurativa and vitiligo, further support JAK inhibitors’ generally favorable safety profile, with Song pointing to lower rates of serious AEs/ Longer-term placebo-controlled data, including 48-week trials, may be warranted to allow for additional reassurance as the evidence base continues to grow.
For further information on this discussion, view the full interview segment posted above.
Song has reported serving as an investigator, consultant, and/or speaker for AbbVie, Alphyn Biologics, Amgen, Apogee, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, DermBiont, Galderma, Incyte, Janssen, LEO Pharma, MoonLake, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharmaceutical Industries, Timber Pharmaceuticals, and UCB.
References
Song E. F099 JAK Inhibitors in Dermatology: Identifying Ideal Candidates. Sesson presented at: 2026 American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO.
Smith T. Rethinking the Black Box: JAK Inhibitors Find Their Place in Dermatology. HCPLive. October 21, 2025. April 2, 2026. https://www.hcplive.com/view/rethinking-black-box-jak-inhibitors-find-their-place-dermatology.
