Emma Guttman-Yassky, MD, PhD, the Waldman Professor and Chair of Dermatology at Icahn Mount Sinai and the Mount Sinai Health System in New York City, has been awarded a new $6.6 million, five-year National Institutes of Health (NIH) U01 grant to investigate dupilumab (Dupixent, Sanofi & Regeneron) as a treatment for children with alopecia areata.
This grant will fund a collaborative effort to investigate the safety, tolerability, efficacy, and durability of response of subcutaneous administration of dupilumab in pediatric patients with extensive alopecia areata, defined as affecting at least 30% of the scalp.
“Alopecia areata causes tremendous psychosocial distress and greatly affects the patient’s quality of life as well as negatively impacting the entire family. This is particularly impactful in children, as they do not yet have the coping mechanisms adults may have,” says Dr. Guttman-Yassky, also a TDD Editorial Advisory Board Member, in a news release. “Current treatment options for alopecia areata harbor negative side effects for long-term use. In addition, the moment you stop using the treatment, the hair typically sheds a few months later. This funding will enable us to embark on a transformative journey, pushing the boundaries of alopecia research and paving the way for innovative solutions to this burdensome disease.”
There is evidence of a strong relationship between alopecia areata and atopic diseases like eczema, allergic rhinitis, asthma, and food allergy in the general population, and an even stronger association in children, she says. “Among children with alopecia areata, 33% have atopic dermatitis, 21% have asthma, 20% have hay fever, and 14% have another type of allergy.”
. A recent clinical trial of adult alopecia patients with severe hair loss showed that dupilumab induced significant hair regrowth, encouraging Dr. Guttman-Yassky to explore dupilumab as a treatment for alopecia areata in pediatric patients with a history of atopic diseases.
To conduct this work, Dr. Guttman will lead a controlled trial of 76 children (6-17 years old) with alopecia affecting at least 50% of the scalp, who will be randomized 2:1 (dupilumab to placebo) for 48 weeks, followed by 48 weeks open-label dupilumab to all participants so everyone can benefit, and lastly 16 weeks follow-up, for a total of 112 weeks.
“This exciting NIH-funded clinical trial aims to expand our mechanistic understanding of alopecia areata and shed light on the regulatory immune circuits in the pathogenesis of AA, particularly in children and adolescents,” said. Dr. Guttman. “If successful, this trial holds promise to change the treatment of alopecia areata, enabling the use and further development of targeted therapeutics, which can be safe for long-term use.”
PHOTO CREDIT: DermNet
