PURPOSE OF THE STUDY.
To assess the safety and efficacy of an oral desensitization protocol in 2-year-old children with allergy to cow’s milk protein (CMP) as a therapeutic alternative to elimination diet.
Sixty patients aged 24 to 36 months with immunoglobulin (Ig) E-mediated allergy to CMP enrolled in this multicenter study. Inclusion criteria included immediate-type clinical manifestations within 2 hours of cow’s milk ingestion, skin prick tests ≥3 mm, and serum specific IgE levels ≥0.35 kU/L for whole cow’s milk, casein, α-lactalbumin, or β-lactoglobulin. Persistence of CMP allergy in the 4 weeks before tolerance induction was based on positive skin and serum testing and a positive double-blind placebo-controlled food challenge to cow’s milk. Exclusion criteria included anaphylactic shock after cow’s milk ingestion, non-IgE-mediated or nonimmunologic adverse reactions, malignant or immunopathologic disease, immunosuppressive therapy, concurrent β-blocker use, and diseases contraindicating the use of epinephrine.
Patients (n = 79) were recruited in this randomized, parallel group study, 19 declined to participate. Sixty patients were randomly assigned to 1 of 2 groups, each consisting of 30 patients. The active group initiated oral desensitization immediately after food challenge. The control group maintained a milk-free diet for 1 year. The primary study variable was desensitization to CMP 1 year after the start of the trial. Patients tolerating ≥200 mL of cow’s milk were considered desensitized. Skin testing and serum specific IgE testing were repeated 1 year after initial provocation testing.
In the active group, 27 patients (90%) achieved full desensitization, and all remained tolerant of the full dose at the 12-month follow-up visit. Twenty-four patients (80%) had either a mild or moderate reaction during desensitization. The most common adverse reactions were urticaria-angioedema, followed by cough. The mean duration of follow-up was 14.2 months in the active group, and 12.5 months in the control group. Skin reactivity and serum specific IgE to milk and casein decreased significantly in the active group. In the control group, 23 patients (76.7%) remained allergic at the 12-month follow-up visit.
Oral desensitization was effective in a significant percentage of 2-year-old children with CMP allergy. Oral desensitization is an alternative to elimination diets.
The current study adds to the limited body of information available on alternatives to elimination diets in patients with CMP allergy. Because many children outgrow allergy to CMP, the risks and benefits associated with desensitization in early childhood must be carefully considered. Although no patients in the current study had severe reactions during desensitization, larger studies are needed to fully evaluate the risk of severe adverse reactions.
- Copyright © 2012 by the American Academy of Pediatrics