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Muffins as medicine? Potential treatment for severe milk allergy

Published: November 2, 2021

Cow’s milk allergy is the most common food allergy in young children and has no current treatment. Over the past decade, studies have demonstrated promising results for food oral immunotherapy (OIT), which is a process providing gradually increasing doses of allergenic proteins with the goal of inducing desensitization. However, OIT studies to date have shown high rates of adverse reactions. Treatment approaches that could reduce adverse reactions while maintaining or even improving the ability to tolerate larger amounts are therefore of interest. In that regard, recent studies have shown that extensive heating of milk proteins makes them less allergenic, while still maintaining the antigenic properties needed to induce desensitization.

In a randomized, double-blind, placebo controlled (DBPC) clinical trial recently published in The Journal of Allergy and Clinical Immunology (JACI), Dantzer and colleagues investigated the safety and efficacy of baked milk OIT in 3-18-year-old children with severe milk allergy. After undergoing a screening visit and a baseline food challenge to baked milk, eligible participants (n=30) who reacted to less than 1 tablespoon of baked milk were randomized to receive baked milk OIT or placebo for 12 months. Dosing started with extremely small amounts of baked milk or placebo. Participants returned to clinic every 2 weeks during the build-up phase until they reached a dose of 2000 mg (1/4th cup of milk). They then continued to eat the same dose (as a muffin) daily until they had been on treatment for 12 months. After 12 months of treatment, participants underwent a DBPC food challenge to up to 4044 mg (1/2 cup) of baked milk.  

The study found that after 12 months of treatment, baked milk OIT was significantly more effective than placebo at allowing participants to tolerate 4044 mg (1/2 cup) of baked milk during the DBPC food challenge. The baked milk OIT group also had a greater change in maximum tolerated dose from baseline compared to the placebo group. Dose-related reactions were common but >95% in both groups were mild. The authors also looked at laboratory data and found that there was no significant change in cow’s milk or beta lactoglobulin-IgE from baseline for either group. Cow’s milk-sIgG4 s increased significantly and casein IgE decreased in the baked milk OIT group. For proxy-reported food allergy quality of life, there was a significant difference in the emotional impact domain only with more improving while on placebo compared to active treatment. Most of the children and adolescents in the baked milk OIT group directly reported improvement in at least one quality of life domain.

In summary, this study by Dantzer et al provides evidence of efficacy and acceptable safety of baked milk OIT in children with severe milk allergy. Compared to placebo, the baked milk OIT group was able to ingest without symptoms significantly more baked milk after 12 months of treatment and overall, this treatment was well tolerated. Future analyses will investigate the results from the open-label, second year of treatment, including desensitization to baked and unheated milk, plus long-term follow-up after home introduction of milk.

The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.

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