The IL-4/IL-13 blocker dupilumab leads to rapid symptom control and itch reduction in children with severe atopic dermatitis (AD), as was demonstrated in the phase 3 LIBERTY AD PEDS study .
Previous trials have already shown that dupilumab is effective in adults and adolescents ≥12 years with moderate-to-severe AD inadequately controlled with topical prescription therapies. However, there is also an ongoing medical need for younger children with severe AD. Prolonged use of topical steroids can potentially damage the skin barrier resulting in thinning of the skin. Untreated, moderate-to-severe AD can not only impact a child’s physical development, but can have psychological sequelae, placing a substantial burden on parents and caregivers .
The double-blind phase 3 LIBERTY AD PEDS study aimed to assess the efficacy and safety of dupilumab in children with severe AD aged ≥6 to <12 years (minimum weight 15 kg). All children had an Investigator’s Global Assessment (IGA) score of 4. They were randomised to subcutaneous dupilumab every 2 weeks in 2 dosages according to body weight (100 mg if baseline weight <30 kg and 200 mg if ≥30 kg; n=122), dupilumab every 4 weeks (300 mg regardless of weight; n=122), or placebo (n=123) for 16 weeks. From week 2 onward, all patients initiated standardised treatment with medium-potency topical corticosteroids. The primary endpoint of the study was the percentage of participants with almost clear or clear skin according to the IGA score (0/1 score). In addition, the percentage of patients with an improvement of the Eczema Area and Severity Index (EASI) score by 75% was assessed.
At week 16, 29.5% of the patients with dupilumab treated every 2 weeks, 32.8% of the patients treated every 4 weeks, and 11.4% of patients in the placebo group reached IGA 0/1. EASI 75 improvement was 67.2%, 69.7%, and 26.8%, respectively. Dupilumab led to a significant improvement of pruritus, assessed as mean percent change in the Peak Pruritus Numerical Rating Scale (P<0.001 for all comparisons).
“Dupilumab was well tolerated and the safety profile was consistent with the profile we know from adults and adolescents,” said Prof. Amy S. Paller (Northwestern University, Feinberg School of Medicine, USA). Serious adverse events and adverse event-related treatment discontinuations were rare. Injection-site reactions and conjunctivitis were more common with dupilumab than with placebo.
In conclusion, dupilumab together with topical steroids led to a clinically meaningful and statistically significant improvement in AD signs and symptoms in children <12 years with severe AD.
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1 Paller A, et al. Late-breaking Abstract, AAD Virtual Meeting Experience, 12-14 June 2020.