Children with eczema between the ages of six months and six years benefit from treatment with dupilumab, according to the results of a new international phase 3 study published in The Lancet.
A 16-week course of dupilumab resulted in more than half the children in the study having at least a 75% reduction in signs of eczema and highly significant reductions in itch with improved sleep. The study included 31 sites in Europe and North America.
“Preschoolers who are constantly scratching, awake multiple times a night with their parents, irritable and markedly curtailed in their ability to do what other children their ages can do improved to the extent that they sleep through the night, change their personalities and have a normal life—as babies and children should,” said lead author Dr. Amy Paller in a press release. She is chair and Walter J. Hamlin Professor of Dermatology at Northwestern University’s Feinberg School of Medicine in Chicago.
This randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial included patients aged six months to younger than six years, with moderate-to-severe atopic dermatitis (Investigator's Global Assessment [IGA] score 3–4) diagnosed according to consensus criteria of the American Academy of Dermatology, and an inadequate response to topical corticosteroids. Patients were randomly assigned (1:1) to subcutaneous placebo or dupilumab (bodyweight ≥5 kg to <15 kg: 200 mg; bodyweight ≥15 kg to <30 kg: 300 mg) every four weeks plus low-potency topical corticosteroids (hydrocortisone acetate 1% cream) for 16 weeks.
According to the investigators, the primary endpoint at week 16 was the proportion of patients with IGA score 0–1 (clear or almost clear skin). The key secondary endpoint (coprimary endpoint for the EU and EU reference market) at week 16 was the proportion of patients with at least a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75).
Between June 30, 2020, and Feb 12, 2021, 197 patients were screened for eligibility, 162 were randomly assigned to receive dupilumab (n=83) or placebo (n=79) plus topical corticosteroids. At week 16, significantly more patients in the dupilumab group than in the placebo group had IGA 0–1 (23 [28%] vs. three [4%], difference 24% [95% CI 13–34]; p<0·0001) and EASI-75 (44 [53%] vs. eight [11%], difference 42% [95% CI 29–55]; p<0·0001). Overall prevalence of adverse events was similar in the dupilumab group (53 [64%] of 83 patients) and placebo group (58 [74%] of 78 patients). Conjunctivitis incidence was higher in the dupilumab group (four [5%]) than the placebo group (none). No dupilumab-related adverse events were serious or led to treatment discontinuation.
Dr. Paller noted that treatments for severe AD to date in this age group included immune-suppressing medications, such as oral steroids, which have many side effects.
“The ability to take [dupilumab] will significantly improve the quality of life for infants and young children who suffer tremendously with this disease,” Dr. Paller said. “Atopic dermatitis or eczema is so much more than just itchy skin. It is a devastating disease. The quality of life of severe eczema—not only for the child but also parents—is equivalent to many life-threatening diseases.”