COW’S MILK allergy (CMA) is the most common food allergy in children, though some may outgrow it by adolescence or adulthood. CMA can significantly impact daily life, causing frequent severe reactions, nutritional deficits, and financial and emotional burdens. While oral immunotherapy (OIT) for peanut allergy has shown success, CMA treatment, particularly with unheated milk, presents challenges due to higher risks of severe reactions.
Extensively heating milk, such as through baking, alters its proteins, making them less allergenic while retaining the properties needed to induce tolerance. Studies show 50%-70% of children with CMA can tolerate baked milk (BM) in foods like muffins. Introducing BM often leads to better tolerance of less-cooked forms and increases the likelihood of outgrowing CMA. However, patients with severe CMA cannot safely consume BM, highlighting the need for alternative approaches.
A recent study explored a baked milk oral immunotherapy (BMOIT) protocol for children with severe CMA. This Phase 2, randomised, double-blind, placebo-controlled trial involved lower starting doses and gradual escalations to enhance safety and efficacy. After 12 months, 79% of the BMOIT group could tolerate 4044 mg of BM protein, compared to none in the placebo group. After 24 months, 63% could tolerate BM, and 43% tolerated unheated milk (UM).
The treatment was well-tolerated, with most adverse effects mild and decreasing over time. Immunological studies revealed promising mechanisms for desensitisation, including increases in IgG4 antibodies and regulatory T cells, and decreases in IgE antibodies and pathogenic T cells.
BMOIT offers a safer and more effective pathway for children with severe CMA to build milk tolerance. While challenges remain, such as the need for larger studies and improved protocols for long-term tolerance, this innovative approach is a significant step towards improving outcomes for CMA patients.
Katie Wright, EMJ
Reference
Dantzer JA et al. Clinical and immunological outcomes after randomized trial of baked milk oral immunotherapy for milk allergy. JCI Insight. 2025;10(1):e184301.
