Ilona Frieden, MD

Dupilumab (Dupixent; Sanofi/Regeneron) received FDA approval on June 7, 2022, for children aged 6 months to 5 years with 

. Its utility, however, may extend well beyond labeled indications.

, Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, outlined a growing body of evidence supporting off-label use of dupilumab across a range of pruritic and inflammatory pediatric skin conditions.

 In the following Q&A, Frieden discusses which conditions are generating the most interest, how she weighs the risk-benefit calculus in pediatric patients, and why safety data borrowed from other specialties can help guide decision-making.

Can you walk us through what you're covering on the expanding use of dupilumab?

 With dupilumab, I really talk about the fact that it's FDA-approved for atopic dermatitis, down to just a few months of age. It's also approved for children age 12 and over for chronic spontaneous urticaria.

We see children who have prurigo nodularis as a disease manifestation, but it's only approved for adults with prurigo nodularis. Certainly, we use drugs commonly off label, and so we would consider it for that.

There’s a whole list of expanded indications that have been reported in small case series or sometimes larger case series for things that are itchy for other reasons. There's a rare form of epidermolysis bullosa that's very itchy—it's really life-transforming for that. It's called EB pruriginosa, which stands for pruritic EB. There's also a form of ichthyosis, what's now called epidermal differentiation disorder, [and] Netherton syndrome, another rare disease [with] severe pruritus, where it can be transformative.

HCPLive: Can you provide examples of which conditions use the expanded use of dupilumab?

One is a disease called solid facial edema, which is considered to be possibly a form of lymphatic disruption, often due to acne on the face. It's a very rare disease, but there's a report in the literature from last year, and I show a very dramatic case of a patient of ours where it was truly incredibly effective.

We don't really know why, because dupilumab has a very narrow spectrum as an antagonist of IL-4 and 13. But there's a lot we don't know about biology, and anything that has some degree of inflammation or itch is certainly something we can consider. We know it's a very safe medication in children because it's been used in tens of thousands of pediatric patients at this point for atopic dermatitis.

I also show an example of older patients who have chronic irritation in the groin area, sometimes from leaking of urine. These are children who have an increased propensity for accidents, and sometimes they have developmental disabilities, so they don't control their bowel and bladder very well, and sometimes they're in diapers. Anecdotally, we've seen that some of those patients improve a lot with dupilumab, which is not something we would necessarily expect, but it might be something worth trying in some of these tough management cases.

HCPLive: What is your central principle in evaluating whether you are going to try a new medication?

 One of the central principles I use in evaluating whether I'm going to try a new medication is what’s our experience in children in other diseases? Because we can have a lot of safety data even if we don't have data about a specific illness. In many conditions we borrow—for example, other biologic agents—pediatric rheumatologists or gastroenterologists will be using drugs like Humira long before we do. They have a lot of safety data in children, and we can borrow from them and say, ‘well, this is the experience in children that's already been looked at, even if it's not for the condition we're treating.’

That's one of the ways that, as pediatric dermatologists, we try to extrapolate whether or not it's worth taking the risk [or] whether the benefit might outweigh the risk for very difficult cases.

Butera A. FDA Approves Dupilumab as Add-On for Youngest Atopic Dermatitis Patients. HCPLive. Published on June 7, 2022. Accessed June 26, 2026.

Pediatric Dermatology Update 2026. Session presented at the Maui Derm Summer 2026 meeting in Colorado Springs on June 26.

Articles

Dupilumab is FDA-approved for pediatric atopic dermatitis down to 6 months and for chronic spontaneous urticaria in patients ≥12 years, yet mounting pediatric dermatology experience supports broader off-label exploration. Reported benefits span intensely pruritic, inflammatory, and rare genodermatoses, sometimes with life-altering itch reduction. Despite its relatively narrow IL-4/IL-13 blockade, clinical responses have been observed in conditions with unclear pathobiology. Off-label decision-making is guided by disease severity, therapeutic need, and extrapolated pediatric safety data from other specialties’ biologic use.

Frieden on expanding dupilumab use in pediatric skin conditions: prurigo nodularis, EB pruriginosa, and more.