The biologic monoclonal antibody dupilumab is effective against eczema in young children aged from six months to six years of age, according to phase 3 trial results.
Presented at the British Association of Dermatology 2022 meeting in Glasgow on 5 July, findings of the Liberty Ad Preschool trial showed that treatment with dupilumab combined with low-potency topical corticosteroids resulted in more than half of children achieving a clinically meaningful improvement in eczema at 16 weeks.
The biologic treatment also appeared to have an acceptable safety profile, according to study investigators.
The study was a double-blind, randomised placebo-controlled trial that enrolled 162 children with moderate-to-severe atopic dermatitis [IGA score ≥ 3] that was inadequately controlled with topical therapies.
The treatment group received subcutaneous dupilumab every four weeks, and from two weeks all patients received standard low-potency topical corticosteroids.
At week 16, 27.7%/ of patients receiving dupilumab achieved an IGA score of 0–1 (clear/almost clear) compared to 3.9% of the placebo group (P < 0.001).
A clinically significant change (≥ 75% improvement in Eczema Area and Severity Index [EASI] score) was seen in 53.0% of dupilumab treated children and 10.7% of the placebo group (P < 0.001).
Improvements were also seen in outcomes such as change in EASI –70.0% vs –19.6% for dupilumab vs placebo (P < 0.001) and in parent/caregiver-assessed weekly averaged worst scratch/itch score–49.4% vs –2.2% (P < 0.001), respectively.
Changes in a parent/caregiver-assessed eczema score (range 0–28) from baseline to week 16 were–12.9 for dupilumab and -3.8 for placebo (P < 0.001).
The study investigators said improvements in eczema with dupilumab were rapid and statistically significant by week four, and were maintained through the treatment period.
They noted that the safety profile of dupilumab in young children was similar to that observed in adults and older children. Rates of serious adverse events and adverse event related discontinuations were 0% vs 5.1% and 1.2% vs 1.3%, respectively, in the dupilumab/placebo groups.
Conjunctivitis (narrow cluster) occurred in 4.8% vs 0%, in the dupilumab/placebo groups, while the incidence of skin infection (excluding herpes infection) was 12.0% vs 24.4% respectively and the incidence of herpes viral infections was 6.0% vs 5.1% in the dupilumab/placebo groups.
The study was supported by Sanofi, which recently announced the FDA approval of dupilumab for the treatment 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.
“Regulatory filings for this age group are underway by the European Medicines Agency and regulatory authorities in additional countries,” the company said in a statement released on 7 June.
In Australia, dupilumab was recently approved by the TGA for use in children aged six years and over, but is not yet listed on the PBS for that indication.