Baked Milk Oral Immunotherapy Leads to Improvements for Patients with Cow’s Milk Allergy

Jennifer Dantzer, MD, MHS

Credit: Johns Hopkins Institute for Clinical and Translational Research

Baked Milk Oral Immunotherapy (BMOIT) may lead to substantial desensitization to both baked and unheated milk among patients with cow’s milk allergy, according to recent findings.¹

These findings, slated for presentation at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Washington, DC, demonstrated that those with 1 of the most common food allergies among adolescents may be better addressed through newer forms of immunotherapy.

“Cow’s milk allergy is the most common food allergy in young children and while often outgrown, approximately 20% persists into adolescence and adulthood,” the study’s primary Jennifer Dantzer, MD, MHS, said in a statement. “Due to the ubiquitous nature of milk, avoidance is difficult leading to frequent and often severe reactions in addition to social and dietary restrictions leading to a major impact on quality of life.”

Prior research had shown that cow’s milk allergy had grown in prevalence among children since 2013, with a representative sample of US households being evaluated. These findings had suggested that 1.9% of children in the US had a convincing milk allergy.²

A treatment shown to be effective against milk allergy is necessary, Dantzer explained, and it is because of this awareness among clinicians that the investigators carried out this trial.¹

The phase 2 study conducted by Dantzer and colleagues involved a double-blind, placebo-controlled design and took place over the course of 12 months. During the study, the investigators compared the use of BMOIT among patients with cow’s milk allergy against a placebo.

After the completion of oral food challenges in a single year, the study was unblinded. The research team transitioned those in the placebo arm to active therapy, continuing the BMOIT group’s course of 2000 mg of treatment for another year.

Participants received additional oral food challenges at the 2-year mark, with the challenges involving unheated as well as baked milk.

Overall, the research team reported that 24 out of 30 of those randomized in the study had carried the year 2 oral food challenges to their conclusion. The team added that among these participants, 92% were shown to tolerate approximately 2g baked milk doses.

Additionally, the investigators found that 79% of the subjects were able to consume and tolerate the maximum cumulative dose of 4g. The research team noted that no discernible distinction was observed as far as tolerance between subjects treated with BMOIT for 12 or for 24 months.

However, participants receiving BMOIT for 24 months demonstrated a higher median tolerance level for unheated milk compared to those initially in the placebo group who had received only 12 months of treatment, suggesting that prolonged treatment duration may enhance efficacy.

Symptoms were reported with 12% of baked milk doses over the course of the second year of the study, with symptoms being mild in large part and having no reported instances of severe reactions. The team did note, however, that among reactions which were reported by the participants, oropharyngeal and gastrointestinal symptoms were shown to be most common.

Dantzer and colleagues added that as 1 of the most prevalent food allergies observed in young children, cow’s milk allergy may require definitive immunotherapy options for patients. The team’s study on BMOIT may allow for greater insight into possible future choices for treatment.

“We were excited to find that baked milk oral immunotherapy in children with severe milk allergy appears to be both safe and efficacious,” Dantzer concluded.

References

1. ^{Baked Milk Oral Immunotherapy Found to be Effective Treatment for Cow’s Milk Allergy. American Academy of Allergy, Asthma & Immunology. February 5, 2024. https://www.aaaai.org/about/news/news/2024/baked. Date accessed: February 21, 2024.}
2. ^{Castles T. Percentage of Food-Allergic Children Who Are Allergic to Milk Grows by Over 30%. HCPLive. November 16, 2018. https://www.hcplive.com/view/percentage-of-foodallergic-children-who-are-allergic-to-milk-grows-by-over-20. Date accessed: February 21, 2024.}