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Phase 2 Trial of Single-Dose Dupilumab in Children with Atopic Dermatitis


Benjamin Lockshin, MD, FAAD, reviews key findings from a phase 2 trial evaluating the safety and efficacy of single-dose dupilumab in children with severe atopic dermatitis.

Benjamin Lockshin, MD, FAAD: This was a great lead-up study to show the tolerability as well as the safety of a medication, either 3 mg/kg or 6 mg/kg as a single dose in children 6 months to 6 years of age with severe atopic dermatitis.

There were some notable findings from the pharmacokinetic analysis in this patient group. The first is that the 3 and 6 mg/kg groups showed more than a dose-related change in terms of the area under the curve where the 6 mg/kg dosing group had a much larger area under the curve.

Although this study was not powered for efficacy analyses, there were some trends that we certainly cannot ignore. One is that there was a significant mean decrease in about 40% in both of the dosing groups. Other notable metrics include improvement of the SCORAD [scoring atopic dermatitis], as well as the SCORAD VAS [visual analog scale] scores for itch and sleep as well as the caregiver reported Peak Pruritus NRS [numerical rating scale] at 3 weeks.

In fact, between 40% and 50% of the children achieved a passing 50 after just 1 dose.

It’s always nice to see a follow-up study, especially if you expand the age of enrollment for these patients, to see no amplification of safety signals and really no new, true meaningful safety signals. The more time we have using dupilumab [Dupixent], the more reassurance we get, certainly in the older patient population, of new signals. Certainly, as you creep down from age group to age group, especially in this younger patient population, the safety profile is consistent with what we’re accustomed to telling our older patients.

Transcript Edited for Clarity

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