- Between 15 and 20% of children worldwide have an inflammatory skin condition known as eczema.
- Results from a phase 3 clinical trial showed that the drug dupilumab had at least 75% improvement in eczema symptoms in children aged 6 months to 5 years.
- US regulators approved the use of dupilumab in children aged 6 months to 5 years in June 2022.
Between 15 and 20% of children around the world suffer from eczema — an inflammatory skin condition that is currently incurable.
Based on its symptoms, previous research shows that children with eczema — known clinically as atopic dermatitis — have higher rates of mental health problems such as depression and anxiety. They may also have trouble sleeping.
A phase 3 clinical trial recently published in The Lancet now reports that the drug dupilumab caused at least 75% improvement in eczema symptoms in children aged 6 months to 5 years by week 16 when used in conjunction with a topical corticosteroid.
What is eczema?
Atopic dermatitis is a chronic inflammatory skin condition that is caused by a variety of reasons, including a person’s inflammatory response, specific triggers, genetic history, and stress.
Symptoms of eczema include:
- extremely dry, scaly and/or chapped skin rashes
- on the neck, wrists and ankles or behind elbows and knees, in children
- red, irritated skin blisters/wounds
- , which break easily and liquid escapes
Not a cure for atopic dermatitis, but doctors treat flare-ups of the disease and take preventative measures for future outbreaks. To the
Traditional medicines for eczema include:
- corticosteroid creams
Atopic dermatitis in children
Eczema is common in children. Research shows that 60% of children develop eczema symptoms for the first time in their first year of life in some children, outgrowing eczema in adulthood.
“Babies and young children with uncontrolled atopic dermatitis can constantly scratch, be irritable and alert at night with their parents, which can impair (the) quality of life of both children and their parents,” explained Dr. Amy S. Paller, Department of Dermatology and Professor of Pediatrics at the Feinberg School of Medicine from Northwestern University in Illinois and Principal Investigator of the Phase 3 clinical trial.
According to Paller, there was a need for treatment options for infants and young children with uncontrolled moderate to severe atopic dermatitis before the Food and Drug Administration began using Dupixent in children aged 6 months to 5 years with moderate to severe atopic dermatitis in June 2022.
“Treatment options for patients aged between 6 months and 5 years were primarily limited to topical steroids,” she explained to Medical News Today. “Given that the options were otherwise just immunosuppressants such as oral steroids, cyclosporine, and methotrexate, we as pediatric dermatologists were very hesitant to switch to anything other than topical steroids. And frankly even concerned about the chronic use of strong steroids, which some of these kids with moderate to severe eczema need for partial control.”
What is dupilumab?
Dupixent (dupilumab) is a drug developed by Regeneron Pharmaceuticals Inc., and developed jointly by Regeneron and Sanofi.
The Food & Drug Administration (FDA) approved Dupixent for the treatment of atopic dermatitis in adults for the first time in March 2017. The FDA then expanded Dupixent’s use in 2020 to children aged 6 to 11 years before it was approved for children aged 6 months to 5 years earlier this year.
Paller stated that dupilumab is a biological medicine that helps combat an underlying source of inflammation — called type 2 inflammation — that contributes to atopic dermatitis. She added that dupilumab is not an immunosuppressant or steroid.
“Many parents and caregivers of babies and young children with uncontrolled moderate to severe atopic dermatitis have tried multiple topical therapies, and some have even tried systemic steroids or broad-based immunosuppressants and are still left uncontrolled, prompting them to seek out new options,” she said explained. “Long-term use of corticosteroids and off-label immunosuppressants may be temporarily effective but may also be associated with significant side effects.”
Efficacy of dupilumab in young children
The phase 3 clinical trial examined the safety and efficacy of dupilumab in 162 children aged 6 months and 5 years with uncontrolled moderate to severe atopic dermatitis.
Study participants received either an injected dose of the drug in conjunction with a low-efficacy topical corticosteroid every four weeks, or only the topical corticosteroid in the placebo group.
After 16 weeks of treatment, researchers reported that more than half of the participants who received dupilumab had an improvement of at least 75% in their eczema area and severity index (EASI-75). Physicians use the EASI-75 to measure the number of inflamed areas on the body and their severity.
The researchers also found that 48% of participants who received dupilumab had a reduction in itching after 16 weeks and 28% had almost clear or clear skin.
“The study showed that the effect of dupilumab on most of these younger children is dramatic and at least as good as we’ve seen with the riskier immunosuppressants,” commented Paller. “It is important that even though dupilumab is injected every 4 weeks, there is only a huge safety advantage and children do not need the frequent blood draws to monitor the safety required for other medications — in fact, dupilumab does not require blood draws.”
In terms of safety, the research team reported a similar safety profile as patients aged 6 and over taking dupilumab for atopic dermatitis.
The most common side effects observed in children participating in the dupilumab group during the clinical trial included:
- herpes virus infection (6%)
- pink eyes, clinically known as conjunctivitis (5%)
- Molluscum contagiosum (5%)
- runny nose, clinically known as rhinorrhea (5%)
- Caries or tooth decay, clinically known as dental caries (5%)
“Dupilumab has been studied in a number of extensive clinical trial programs and showed a strong safety profile across a range of age groups and was studied in young children for up to one year,” Paller reported. “The safety results of the study and of a one-year open-label extension study in children aged 6 months to 5 years were generally consistent with the known safety profile of dupilumab in patients aged 6 years and over. This is limited to a few injection site reactions that were actually not seen in the studies in these 6-month to 5-year-old children compared to placebo, and some increased eye redness or conjunctivitis — still in the minority and treated with some medications.”
“Super exciting data”
MNT also spoke with Dr. Emma Guttman-Yassky, professor and system chair for the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York, about this data from clinical trials.
“This is super exciting data as we haven’t had safe and effective treatments for our atopic dermatitis patients so far,” she said. “Dupilumab is a specific immunomodulator that is safe for long-term use, as opposed to previously used immunosuppressants, which are not as safe for long-term use.”
When asked about the safety profile of dupilumab, Guttman-Yassky commented: “It is important to inform parents about the possibility of conjunctivitis/dry eye disease, but overall the safety profile was very good.”
Guttman-Yassky also mentioned that there is some additional research she’d like to see for dupilumab.
“I would like minimally invasive biomarker approaches, such as ligament strips, which we’ve shown in infants and children, to be used in such studies to inform about pathogenesis,” she said.