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Abstract
We evaluated the efficacy and safety of oral immunotherapy (OIT) combined with 24 weeks of omalizumab (OMB) at inducing desensitization in children with cow’s milk allergy (CM) compared with an untreated group. The present study was a prospective randomized controlled trial. Sixteen patients (age, 6–14 years) with high IgE levels to CM were enrolled in the present study. Patients were randomized 1:1 to receive OMB-OIT group or untreated group. The primary outcome was the induction of desensitization at 8 weeks after OMB was discontinued in OMB-OIT treated group and at 32 weeks after study entry. None of the 6 children in the untreated group developed desensitization to CM while all of the 10 children in the OIT-OMB treated group achieved desensitization (P < 0.001). A significantly decreased wheal diameter in response to a skin prick test using CM was found in the OMB-OIT treated group (P < 0.05). These data suggest that OIT combined with OMB using microwave heated CM may help to induce desensitization for children with high-risk CM allergy. This prospective randomized controlled trial was intended for 50 participants but was prematurely discontinued due to overwhelming superiority of OMB combined with microwave heated OIT over CM avoidance.
Highlights
We evaluated the efficacy and safety of oral immunotherapy (OIT) combined with 24 weeks of omalizumab (OMB) at inducing desensitization in children with cow’s milk allergy (CM) compared with an untreated group
As many as 20–30% of patients with food allergy are refractory to desensitization, those with higher initial food specific immunoglobulin E levels16,17
Significant differences were not observed between the two groups for any baseline level of IgG subclass (CM, casein, β-lactoglobulin) or IgA characteristics(data not shown): CM-sIgG1 (1385 vs 792 BUg1/mL); casein-sIgG1 (1729 vs 941 BUg1/mL); β-lactoglobulin-sIgG1 (193 vs 145 BUg1/mL); CM-sIgG2 (330 vs 293 BUg2/mL); casein-sIgG2 (361 vs 371 BUg2/ mL); β-lactoglobulin-sIG2 (80 vs 85 BUg2/mL), CM-sIgG3 (50 vs 50 BUg3/mL); casein-sIgG3 (50 vs 50 BUg3/ mL); β-lactoglobulin-sIG3 (50 vs 50 BUg3/mL); CM-sIgG4 (89 vs 75 BUg4/mL); casein-sIgG4 (89 vs 69 BUg4/ mL); β-lactoglobulin-sIG4 (51 vs 50 BUg4/mL)
Summary
We evaluated the efficacy and safety of oral immunotherapy (OIT) combined with 24 weeks of omalizumab (OMB) at inducing desensitization in children with cow’s milk allergy (CM) compared with an untreated group. A significantly decreased wheal diameter in response to a skin prick test using CM was found in the OMB-OIT treated group (P < 0.05) These data suggest that OIT combined with OMB using microwave heated CM may help to induce desensitization for children with high-risk CM allergy. The aim of the present study was to evaluate the efficacy in the introduction of desensitization and safety of OIT combined with OMB for 24 weeks in children with high-risk CM allergy compared with an untreated group. Characteristic Gender (male) Age at the challenge test Median (Range) Initial total IgE level (IU/mL) Median (IQR) Initial CM-specific IgE level (kUA/L) Median (IQR) Initial Casein, β-lact, α-lact, -specific IgE level Casein, Median (IQR, kUA/L) β-lact, Median (IQR, kUA/L) α-lact, Median (IQR, kUA/L) Wheal diameter of SPT (mm) Fresh CM Median (IQR) MH-CM Median (IQR) Standard CM exact Median (IQR) Histamine Median (IQR) Presence of Other Food Allergies No Yes Frequency of anaphylaxis at accidental ingestion Never Once 2-10 times >10 times Atopic dermatitis Asthma Severity of asthma* Intermittent Moderate Persistent SCD of CMP at DBPCFC (mg), median (IQR) SCD of CM at fresh OFC (mL), median (IQR) SCD of CM at MH-OFC (mL), median (IQR)
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