Dupilumab Appears Safe for Use in Patients Younger Than 5 Years with Atopic Dermatitis

A study found that dupilumab was clinically beneficial in reducing signs and symptoms of atopic dermatitis (AD) in children aged two to five years. The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020.

The phase II/III two-part LIBERTY AD PRE-SCHOOL and INFANT study included children aged two to five years with severe AD that was inadequately controlled with topical therapies. In part A, researchers assessed the pharmacokinetics, safety, and efficacy of dupilumab. In part B, researchers evaluated the safety and efficacy of dupilumab, of which the data collection is ongoing, and the results were not yet reported.

Patients in part A received a single dose of dupilumab 3 mg/kg (n=10) or 6 mg/kg (n=10); the study started with the lower dose to allow for evaluation of the drug’s safety.

A single dose of dupilumab resulted in a greater than dose-proportional increase in dupilumab concentrations with increasing dose for each group. At day three post-dose, patients who received a single dose of dupilumab 3 mg/kg had mean dupilumab concentrations in serum of 21.5 mg/L, while patients who received a single dose of dupilumab 6 mg/kg had mean concentrations in serum of 49.5 mg/L. After day three, mean concentrations in serum decreased over time in both dose groups and were lower than the lower limit of quantitation (0.0780 mg/L) by week four in the dupilumab 3 mg/kg group.

At week four, mean percent change in Eczema Area and Severity Index (EASI) was −26.6 in the 3 mg/kg group and −48.7 in the 6 mg/kg group. The proportion of patients who achieved EASI 50 was 30% and 40%, respectively, and the proportion of patients who achieved EASI 75 was 20% and 30%, respectively.

Caregiver-reported Peak Pruritus Numerical Rating Scale decreased by a mean −16.7% with dupilumab 3 mg/kg and by −22.0% with dupilumab 6 mg/kg. Mean percent body surface area affected by AD decreased to approximately 40% in both dosing cohorts.

Five treatment-related adverse events (AEs) were reported in three patients in the 3 mg/kg group and three AEs were reported in two patients in the 6 mg/kg group. One serious AE occurred in the 3 mg/kg group, which was considered unrelated to treatment, according to the researchers. No injection-site reactions occurred.

Simpson EL, Lockshin B, Kamal M, et al. Pharmacokinetics, Safety, and Efficacy of Dupilumab in Children Aged ≥ 2 to < 6 Years With Severe, Uncontrolled Atopic Dermatitis (LIBERTY AD PRE-SCHOOL). Presented during the AAD Virtual Meeting Experience 2020, June 12-14, 2020.