EPIT with Viaskin milk viable therapeutic option for immunoglobulin E-mediated cow's milk allergy: JAMA

IgE-mediated CMA poses significant challenges for affected children and their families, as it can lead to severe allergic reactions and impact quality of life. This study was published in the journal JAMA Pediatrics by Daniel P. and colleagues.

This phase 1/2 clinical trial enrolled 198 children aged 2 to 17 years with confirmed IgE-mediated CMA. The study evaluated the safety and efficacy of Viaskin milk at doses of 150 μg, 300 μg, and 500 μg compared to placebo over a 12-month treatment period. The primary outcome measure was the proportion of treatment responders based on the cumulative reactive dose of cow's milk protein at the month 12 food challenge.

• Among the participants, 95.5% completed the treatment regimen.

• The highest treatment response rate (49.0%) was observed in children who received Viaskin milk at the 300-μg dose, compared to 30.2% in the placebo group.

• This response was particularly notable in children aged 2 to 11 years, with a response rate of 57.9% in the 300-μg dose group compared to 32.5% in the placebo group.

• Most adverse events were mild or moderate application-site reactions, with low rates of treatment-related anaphylaxis.

The findings of this trial suggest that 12 months of daily epicutaneous immunotherapy with Viaskin milk at a dose of 300 μg is associated with a statistically significant treatment response in children with IgE-mediated CMA. Treatment-related adverse events were generally mild, and discontinuation rates were low. Further research is warranted to confirm these findings and explore Viaskin milk as a potential treatment option for children with CMA.

Epicutaneous immunotherapy using Viaskin milk shows promise as a novel approach to treating cow's milk allergy in children. The study's findings underscore the need for additional research to validate these results and assess the long-term efficacy and safety of this therapeutic approach.

Reference:

Petroni, D., Bégin, P., Bird, J. A., Brown-Whitehorn, T., Chong, H. J., Fleischer, D. M., Gagnon, R., Jones, S. M., Leonard, S., Makhija, M. M., Oriel, R. C., Shreffler, W. G., Sindher, S. B., Sussman, G. L., Yang, W. H., Bee, K. J., Bois, T., Campbell, D. E., Green, T. D., … Wood, R. A. Varying doses of epicutaneous immunotherapy with Viaskin milk vs placebo in children with cow’s milk allergy: A randomized clinical trial. JAMA Pediatrics,2024. https://doi.org/10.1001/jamapediatrics.2023.6630