Journal of Allergy and Clinical Immunology
Safety of Viaskin Milk Epicutaneous Immunotherapy (EPIT) in IgE-Mediated Cow's Milk Allergy (CMA) in Children (MILES Study)
Section snippets
Rationale
EPIT is a promising method for treating food allergy. A dose-finding phase 1/2 study is ongoing to evaluate the safety and efficacy of EPIT using an epicutaneous delivery system Viaskin containing milk proteins, in children aged 2-17 years with IgE-mediated CMA.
Methods
The safety of EPIT in CMA children was evaluated in 3 successive cohorts of 6 subjects receiving Viaskin Milk (150μg, 300μg or 500μg cow’s milk protein) versus placebo in a 2:1 ratio following a 3-week course of treatment.
Results
Eighteen subjects with cow’s milk sIgE≥10kUA/L and reacting objectively at ≤300mg of cow’s milk protein were randomized and remained double-blinded to treatment assignment. At study entry, the median age was 8 years, median cow’s milk sIgE was 88kUA/L and median cumulative milk protein reactive dose was 149mg. No serious adverse events occurred and no epinephrine was required for drug-related-AEs. Most subjects reported local itching (83.3%), redness (83.3%) or swelling (72.2%) at least once.
Conclusions
No safety concerns were noted at any of the 3 doses tested from the DSMB reviews. These safety results warrant continuation of all 3 doses for efficacy assessment of Viaskin Milk in children with CMA.