Contextualizing the JAK Inhibitor Black Box Warning in Dermatology

The black box warning for Janus kinase (JAK) inhibitors has long been part of clinician and patient conversations in dermatology. However, according to Diego Ruiz Dasilva, MD, a dermatologist at Forefront Dermatology in Virginia Beach, Virginia, and an assistant professor at Eastern Virginia Medical School, that hesitation is largely misplaced. At the 2026 American Academy of Dermatology (AAD) Annual Meeting, Dasilva codirected a session titled “JAKpot! Therapeutic Advantages of JAK Inhibitors,” alongside James Song, MD; Mona Shahriari, MD; and Christopher Bunick, MD, PhD.^1,2

The session's central argument was that some clinicians may draw the wrong conclusions from the boxed warning's origins. "The risk of [major adverse cardiovascular events], malignancy, and [venous thromboembolism] in the ORAL Surveillance study [NCT02092467] was in [patients with] rheumatoid arthritis [who are] on tofacitinib—not specifically seen in the atopic dermatitis trials," Dasilva said. Using both clinical trial evidence and real-world data, the panel aimed to demonstrate that the pool of appropriate candidates for JAK inhibition is "much [bigger] than most people think."

He drew a reassuring historical parallel: "One of the oldest things that we've been using for a while now has been tacrolimus or pimecrolimus, which has this box warning from over 20 years ago. Patients kind of understand that that has not been proven over the years." He sees the trajectory for oral JAK inhibitors in atopic dermatitis heading in a similar direction, though he acknowledged that "there's still a lot of progress to be made."

The conversation then turned to psoriasis, during which Dasilva described a genuine shift in his clinical thinking. "Historically, I personally was not excited about any of the orals for psoriasis," he said. The newer biologics, particularly IL-17 and IL-23 inhibitors, had set a high bar for efficacy and convenience that oral options couldn't match. Dasilva’s view is changing with the emergence of envudeucitinib, zasocitinib, and the newly approved icotrokinra. "Within a month, you can see major improvement with [any] of these agents," he noted—a meaningful contrast to older orals that required 3 to 4 months for a visible response.

For the first time, Dasilva says he plans to let patients decide for themselves. "I'm truly going to let the patients pick," he said, citing roughly equal preferences in his atopic dermatitis practice between those who prefer a daily pill and those who favor a quarterly injection.

Dasilva also highlighted ongoing research into dermatitis flares as an adverse effect of approved atopic dermatitis systemics at the 16-week mark. As treatment options continue to expand, he sees a pressing need for better counseling frameworks, cautioning against the impulse to switch therapies prematurely in what he called an "immediate results society."

References

1. Dasilva DR. JAKpot! therapeutic advantages of JAK inhibitors in dermatology: identifying the right patient. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
2. Shahriari M, Song EJ, Dasilva DR, Bunick C. JAK inhibitors in dermatology: identifying ideal candidates. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.