Biologic dupilumab shows efficacy for eczema in young children
Treatment with the biologic drug dupilumab brings relief to children younger than 6 years-old who are suffering with moderate-to-severe atopic dermatitis (eczema)
The findings were published on Sept. 15, 2022 in The Lancet.
“The ability to take this drug will significantly improve the quality of life for infants and young children who suffer tremendously with this disease,” said Amy Paller, MD, chair of dermatology at Northwestern University Feinberg School of Medicine and an attending physician at Ann & Robert H. Lurie Children’s Hospital of Chicago.
“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,” Paller added.
Dupilumab is an FDA-approved for older children and adults with eczema and other type 2 inflammatory conditions.
In this phase 3 study, eligible subjects were aged 6 months to younger than 6 years, diagnosed with moderate-to-severe atopic dermatitis (Investigator’s Global Assessment [IGA] score 3–4) and with a poor response to topical corticosteroid treatment.
The investigators enrolled 162 subjects to receive dupilumab (n=83) or placebo (n=79) plus topical corticosteroids
Treatment was based on bodyweight. Subjects weighing ≥5 kg to <15 kg received subcutaneous 200 mg dupilumab every 4 weeks, and subjects with bodyweight ≥15 kg to <30 kg received 300 mg every 4 weeks. All subjects also received treatment with low-potency topical corticosteroids (hydrocortisone acetate 1% cream). The study lasted for 16 weeks.
The primary endpoint was the proportion of subjects with IGA score 0–1 (clear or almost clear skin).
The key secondary endpoint (the coprimary endpoint in the EU) was the proportion of patients with at least a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75).
At week 16, significantly more subjects in the dupilumab group than in the placebo group had achieved IGA 0–1 (p<0.0001), including 23 dupilumab-treated subjects [28%] and three placebo-treated subjects [4%], a 24% difference.
For EASI-75, 44 [53%] of the dupilumab subjects vs eight [11%] of the placebo subjects achieved the 75% improvement, a significant difference of 42% (p<0·0001).
Adverse event rates were similar in the two groups There were no serious dupilumab-related adverse events, and none led to treatment discontinuation.
The authors concluded, “Dupilumab significantly improved atopic dermatitis signs and symptoms versus placebo in children younger than 6 years. Dupilumab was well tolerated and showed an acceptable safety profile, similar to results in older children and adults.”