Dupilumab Add-on Maintenance Treatment For Children With Atopic Dermatitis

Recently, the US Food and Drug Administration (FDA) approved dupilumab for treating children aged 6 months to 5 years with moderate to severe atopic dermatitis (AD). In this feature Q&A, The Dermatologist met with Mercedes Gonzalez, MD, an investigator in the randomized, placebo-controlled pivotal trial¹, to discuss this approval, including the current treatment landscape for this population and how dupilumab may change the landscape going forward.

Mercedes Gonzalez, MD, is a pediatric dermatologist at the University of Miami School of Medicine in Miami, FL. She was a part of the prestigious pediatrics program at NewYork-Presbyterian Morgan Stanley Children’s Hospital where she specialized in treating skin disorders.

How can the durability of dupilumab affect the quality of life among pediatric patients with AD?

Dupilumab has significantly improved the quality of life for my pediatric patients with moderate to severe AD as it is a different approach to treatment. This is a medication that now targets the actual source of inflammation and the main cytokines involved in the inflammation to help decrease the need for topical treatments. How this contrasts to currently available and standard of care treatments is that before the approval of dupilumab in this age population, the treatment approach would be with topical steroids. You would wait until the patient gets uncomfortable; gets the red, itchy patches and complains to their parent; or the parent sees them uncomfortable and scratching. Then, you reach for your topical steroid, which is going to work by decreasing inflammation altogether, but not in a very specific fashion.

Whereas now, you give dupilumab on a regular basis, and it targets the root cause of the underlying inflammation, which decreases the need for patients to use topical steroids. Overall, this leads to many days where they're not uncomfortable, have decreased itch, and they're not thinking about their AD.

Are there adverse effects that dermatologists should be aware of and monitor their pediatric patients for when using dupilumab?

In this age range, the studies showed that there was no new safety signal. The safety profile was consistent with what was seen in older children, adolescents, and adults. The main adverse effects that we discuss with parents, of course, are injection site reactions. Dupilumab is given by injection, so that's always a possibility. In addition, conjunctivitis was also something that was seen in the pediatric trial, which was similar to older children, adolescents, and adults. Conjunctivitis is something that we discuss with parents before starting the medication. We ask about a history of eye conjunctivitis, and we monitor for those symptoms.

Another point we want to discuss with parents is if patients have concurrent asthma. We want to make sure that they’re continuing to follow up with their asthma provider before they're adjusting any of their asthma medications. Aside from these, the overall good news is that there were no new safety signals seen in this newer pediatric trial in 6 months to 6 years of age.

What does this FDA approval mean for practitioners?

Dupilumab is a welcomed tool in our armamentarium to treat moderate to severe AD. There’s a large unmet need because we know AD is primarily a disease of young children. We know that 90% of patients will present with symptoms at 5 years of age.² Having an FDA-approved treatment that targets the underlying source of inflammation is going to be a significant improvement in terms of the trajectory of these patients' lives. Now we have something that can control their symptoms for the longer term, which will affect how they interact with their peers and how they behave in school. We know that eczema is not just what we see on the skin. When pediatric patients are constantly itchy and uncomfortable, it really affects their participation in school and extracurricular activities. Controlling symptoms on a long-term basis will not only change the trajectory of these young children's lives, but it will also improve the quality of life for their families as well.

References

1. Positive phase 3 Dupixent (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session. News release. Regeneron. December 13, 2021. Accessed on June 7, 2022. https://investor.regeneron.com/news-releases/news-release-details/positive-phase-3-dupixentr-dupilumab-data-children-6-months-5
2. Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part I: clinical and pathologic concepts. J Allergy Clin Immunol. 2011;127(5):1110-1118. doi:10.1016/j.jaci.2011.01.053