The Food and Drug Administration has approved dupilumab as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The approval, announced on June 7, 2022, makes dupilumab (Dupixent), an interleukin-4 receptor alpha antagonist, the first biologic available in the United States to treat uncontrolled moderate-to-severe atopic dermatitis in this age group. In this age group, it is administered subcutaneously every 4 weeks. Dupilumab remains the only biologic treatment approved for patients 6 years of age and older for this indication.
Approval was based on data from a 16-week pivotal phase 3 trial that evaluated the efficacy and safety of dupilumab added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. The trial’s principal investigator, Amy S. Paller, MD, professor and chair of dermatology at Northwestern University’s Feinberg School of Medicine, Chicago, Illinois, and colleagues, found that at 16 weeks, 28% of patients who were treated with dupilumab, added to low-potency TCS, met the primary endpoint of clear or almost clear skin, compared with 4% of those who received low-potency TCS alone (P < .0001).
In addition, patients who received the combined treatment experienced a 70% average improvement in disease severity from baseline, compared with a 20% improvement among those in the TCS-only group (P < .0001). They also experienced a 49% improvement in itch, compared with a 2% improvement among their counterparts in the TCS-only group (P < .0001).
Outside of the United States, the study’s co-primary endpoint was achievement of 75% or greater improvement in overall disease severity. More than half of the patients who received combined treatment (53%) met this endpoint, compared with 11% in the TCS-only group (P < .0001), according to the company.
Safety results were generally consistent with the safety profile of dupilumab in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with dupilumab included conjunctivitis (5% vs 0% in the placebo group) and herpes viral infections (6% vs 0% in the placebo group). Among those on dupilumab, ages 6 months to 5 years, hand-foot-and-mouth disease was reported in 5% and skin papilloma were reported in 2%, but these cases did not lead to discontinuation of treatment, according to the company release.
Press Release: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. Published online June 7, 2022. Source.