D2.162 - Low dose oral immunotherapy for children with severe cow's milk allergy
Background
We previously conducted a randomized controlled trial (Effect of oral immunotherapy in children with milk allergy; ORIMA study) in 28 children aged 3 to 12 years with severe milk allergy (allergic symptoms were triggered by 10 mL or less of milk) (Maeda M et al. Allergol Int. 2021).In the ORIMA study, the treatment group consumed 100 mL of milk every day, while the control group continued to avoid milk, and the rate of a negative cow's milk challenge test of 100 mL of milk was compared one year later. The rate of a negative cow's milk challenge test in the treatment group was 50% compared with 0% in the control group. However, the annual rate of anaphylactic symptoms was about one per patient, indicating a major problem with safety. Therefore, with safety as the primary consideration, low dose oral immunotherapy (OIT) was administered to children with cow's milk allergy of the same severity as in the ORIMA study, and its efficacy and safety were compared with those of the ORIMA study.
Method
The subjects comprised 16 children (aged 3 to 12 years) with allergic symptoms that were induced by ≤ 10 mL of cow’s milk challenge test.
All participants received low-dose OIT (1 mL of milk daily) and then underwent an oral challenge with 100 mL of milk one year later.
Results
Only one participant had a negative oral challenge, and the rate of a negative challenge test was 6.2%. The cow’s milk-specific IgE level was 41.7 ± 39.5 UA/mL, and the cow’s milk intake threshold before registration was 4.25 ± 3.7 mL. After 1 year, the cow’s milk-specific IgE level was 25.5 ± 28.2 UA/mL, and the cow’s milk intake threshold was 38.6 ± 37.0 mL. There was no case of the number of anaphylactic symptoms requiring intramuscular injection of adrenaline.
Conclusion
The effectiveness of low dose OIT of milk was lower than in the ORIMA study. However, there may be some efficacy based on changes in the cow’s milk-specific IgE level and milk intake thresholds. Low dose OIT for children with severe cow's milk allergy may be safe and well tolerated.
