Background
The safety and efficacy of long‐term milk oral immunotherapy (OIT) in Finnish children with persistent cow's milk allergy (CMA) were evaluated in an open‐label, non‐randomized study.
Methods
During the 11‐year study, 296 children aged 5 years or older with immunoglobulin E (IgE)‐mediated CMA started milk OIT. Follow‐up data were collected at three time points: the post‐buildup phase, 1 year thereafter, and at the cross‐sectional long‐term follow‐up between January 2016 and December 2017. Patients were divided according to baseline milk‐specific IgE (sIgE) level and by the amount of milk consumption at the long‐term follow‐up. The high‐dose group consumed ≥2 dL of milk daily, while the failure group consumed <2 dL of milk or were on a milk‐avoidance diet.
Results
Out of the initial study group, 244/296 (83%) patients participated in the long‐term follow‐up. Among these patients, 136/244 (56%) consumed ≥2 dL of milk daily. The median follow‐up time was 6.5 years. Of the recorded markers and clinical factors, the baseline milk sIgE level was most associated with maintaining milk OIT (P < 0.001). Respiratory symptoms in the post‐buildup phase increased the risk of treatment failure (OR 3.5, 95% CI: 1.5‐8.1, P = 0.003) and anaphylaxis (OR 14.3, 95% CI: 1.8‐114, P = 0.01).
Conclusion
More than half of the patients were able to maintain the targeted milk dose in their daily diet. Baseline milk sIgE level and reactivity during the early treatment stage strongly predicted the long‐term outcome and safety of milk OIT.