The first RCT of a biologic to treat moderate-to-severe eczema in children as young as 6 months old has shown the monoclonal antibody was highly effective in reducing signs and symptoms of the disease.

The study, published in The Lancet [link], randomised 162 infants and children from 6 months to 5 years of age to either subcutaneous dupilumab or placebo. The children, from 31 sites in Europe and North America, had a baseline Investigator’s Global Assessment (IGA) score 3-4 and an inadequate response to topical corticosteroids.

After 16 weeks of treatment, significantly more patients in the dupilumab group than in the placebo group had an IGA score 0–1 (28% v 4%; p<0·0001) and a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75) (53% v 11%; p<0·0001).

In other secondary outcomes, such as proportion of patients with ≥4-point improvement of worst scratch and itch NRS score, proportion of patients with EASI-50 and change from baseline in Patient-Oriented Eczema Measure (POEM), dupilumab was superior.

“At week 16, sleep quality in both patients and caregivers was significantly greater in the dupilumab group than in the placebo group,” the study said.

As well, a substantially lower proportion of patients in the dupilumab group compared to the placebo group required one or more rescue medications.

The overall prevalence of treatment-emergent adverse events was similar in both groups (64% v 74%). AEs that occurred more often with dupilumab than placebo included molluscum contagiosum (5% v 3%), viral gastroenteritis (4% v 0%), rhinorrhoea (5% v 1%), dental caries (5% v 0%) and conjunctivitis (5% v 0%).

There were few serious dupilumab-related adverse events or AEs leading to treatment discontinuation.

The study said dupilumab provided clinically meaningful and statistically significant improvements versus placebo in multiple physician-assessed and patient-reported or caregiver-reported outcomes.

“Improvements in multiple domains occurred as early as week 1, including in skin lesions and pruritus.”

“This study provides crucial evidence supporting the efficacy and safety of dupilumab with concomitant topical corticosteroids in this young patient population with a potentially immature immune system.”

“These results constitute pivotal trial data supporting planned global approvals of dupilumab in infants and children with atopic dermatitis and will inform and potentially change clinical practice worldwide.”

A Comment article in the journal [link here] said the findings were “a promising first step” towards better control of atopic dermatitis in very young children.

It also said that treatment with dupilumab or other type 2 inflammatory antibodies in infancy could potentially have disease-modifying effects.

“Reduction in atopic dermatitis severity might lead to skin barrier improvement and increased diversity of the skin microbiome.”

“These changes ultimately might alter the disease trajectory to a milder atopic dermatitis course, or even resolution, and at the same time reduce the risk of developing allergic comorbidities, including food allergy, hay fever, and asthma.”

The study was sponsored by Regeneron Pharmaceuticals and Sanofi, who jointly developed dupilumab.