Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk Versus Placebo in Children With Cow’s Milk Allergy: A Randomized Clinical Trial

A Phase 1 and 2 trial to determine the safety, dose, and efficacy of epicutaneous immunotherapy (EPIT) with Viaskin milk patches for children with immunoglobulin E (IgE)-mediated cow’s milk allergy (CMA).Children 2 to 17 years old with IgE-mediated CMA (n = 198) at 17 trial sites in the United States and Canada.CMA was confirmed before entry with a double-blind, placebo-control food challenge. A 2-part randomized, double-blind, placebo-control trial first assessed the safety of Viaskin Milk patches at 3 doses (150 µg, 300 µg, or 500 µg) with increasing application time (6 hours per day during week 1, 12 hours per day for week 2, and 24 hours per day for week 3) for 3 weeks. After safety was confirmed, children were randomized to receive 150 µg (n = 49), 300 µg (n = 49), or 500 µg (n = 47) or placebo EPIT for 12 months (n = 53). A positive response was defined as children tolerating a 10-fold or more increase in cumulative dose of cow’s milk protein (at least 144 µg) or a cumulative dose of 1444 µg or more at the 12 month double-blind, placebo-controlled food challenge.Of the 95.5% of participants (mean age 8 years [SD: 4.17 years]; 62.6% male; 37.3% female) completing the survey, the highest response was observed in children taking 300 ug of Viaskin Milk, with 24 of 49 (49%) responding compared with 16 of 53 (30.2%) placebo responders (odds ratio, 2.19; 95% confidence interval, 0.91–5.41; P = .09), but was not statistically significant. When comparing prespecified age subgroups, children 2 to 11 years old receiving 300 µg had the highest response with statistical significance (22 of 38 [57.9%] responding versus 13 of 40 placebo responders [32.5%]; P = .04).Although a 300 µg of EPIT with Viaskin milk was not statistically significant across the entire sample, the result was significant for children 2 to 11 years old with IgE-mediated CMA. All doses had low rates of treatment-emergent adverse events.As targeted immunotherapy modalities for IgE-mediated food allergies continue to arise, this study evaluates the treatment safety and efficacy trial of Viaskin milk patches for CMA. Further research should be targeted to further FDA approval of treatment options for children with Ig-E mediated CMA.