Baked milk oral immunotherapy effective at 12 and 24 months

Key takeaways:

• Cow’s milk allergy is the most common food allergy in young children.
• Patients treated for 24 months could tolerate more unheated milk than the patients who were treated for 12 months.

WASHINGTON — Children were desensitized to baked and unheated milk with 12 and 24 months of baked milk oral immunotherapy, according to a study presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.

The study was prompted by the “desire to help kids with a severe milk allergy who had no treatment options,” Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in pediatric allergy, immunology and rheumatology, Johns Hopkins University School of Medicine, told Healio.

Although cow’s milk allergy is the most common food allergy in young children, the researchers said, no treatment is currently available.

Jennifer Dantzer

“It is often outgrown, but some children have a more severe phenotype, which makes them less likely to naturally outgrow their allergy and also does not allow them to tolerate baked milk, such as in a muffin, at typical doses,” said Dantzer, who also is a member of Healio’s Allergy/Asthma Peer Perspective Board.

“We wanted to approach these patients with a severe milk allergy phenotype by combining our experience with milk OIT with the advantages of utilizing extensively heated milk to determine if this would make OIT safer but still efficacious,” she continued.

The phase 2 double-blind, placebo-controlled trial began with 30 children (age range, 3-18 years; 53% boys) with cow’s milk allergy randomly assigned 1:1 to receive baked milk OIT or placebo for 12 months, followed by oral food challenges.

The placebo group then began receiving baked milk OIT and the treatment group continued with 2,000 mg doses for another 12 months. OFCs for baked and unheated milk were conducted at 24 months.

Twenty-two of 24 patients (92%) who completed OFCs for baked milk at 24 months tolerated 2 g or more. Also, 19 (79%) of them tolerated the maximum 4 g cumulative dose. There were no differences between the patients who went from placebo to treatment and the patients who were on treatment for the full 24 months.

Also, 22 of these patients completed OFCs for unheated milk. The two patients who failed the baked milk OFC because they tolerated less than 2 g did not participate in the unheated milk OFCs.

The group on therapy for 24 months tolerated a median of 5,530 mg (range, 1,030-8,030) of unheated milk, and the group on placebo and then therapy tolerated a median of 1,030 mg (range, 430-5,530; P = .01).

“Overall, participants went from reacting to less than 1 tablespoon of baked milk at screening to tolerating at least a quarter to a half cup of baked milk and up to a full cup of unheated milk at month 24,” Dantzer said.

Dantzer also said that she and her colleagues have exciting data about immunologic changes during OIT, changes in quality of life, and home introduction of dietary milk products that they hope to publish soon.

Twelve percent of the baked milk doses between months 12 and 24 were followed by symptoms; however, the researchers classified more than 98% of these symptoms as mild and mostly oropharyngeal and gastrointestinal, with no severe reactions.

Also, the group on therapy for 24 months had a range of zero to 379 adverse events per patient, with a median of six. The group on placebo and then therapy had a range of three to 69 adverse events per patient, with a median of 12.5.

Based on these findings, the researchers characterized baked milk OIT as well tolerated with desensitization for both baked and unheated milk at 12 and 24 months, with longer duration apparently increasing efficacy.

“This has made a big impact for these families, who no longer need to worry about reactions from small amounts of cross-contamination,” Dantzer said. “Many expressed excitement that they could now participate in more social activities and have less food restrictions.”

Yet Dantzer expressed caution about putting these results into practice.

“Our research protocol started with extremely small doses of baked milk that would be difficult to safely measure in a clinic or home setting,” she said.

“However, we previously published the results of our screening challenges for this study that showed that standard testing failed to identify patients who tolerated baked milk and recommended that baked milk in-office food challenges be cautiously considered for milk allergic patients, but need to be conducted with extreme caution,” she continued.

So, although these results indicate that using modified allergens such as baked milk may be a good treatment option, Dantzer said, larger studies are needed.

“Additional studies are needed to further explore using modified allergens with the goal of finding a treatment that is both safe and efficacious,” she said.

References:

• Baked milk oral immunotherapy found to be effective treatment for cow’s milk allergy. https://www.aaaai.org/about/news/news/2024/baked. Published Feb. 5, 2024. Accessed March 11, 2024.
• Dantzer J, et al. J Allergy Clin Immunol. 2024;doi:10.1016/j.jaci.2023.11.749.
• Dantzer J, et al. J Allergy Clin Immunol. 2021;doi:10.1016/j.jaci.2021.10.023.

For more information:

Jennifer Dantzer, MD, can be reached at jwrubel1@jhmi.edu.