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Randomized Controlled Trial
. 2018 Mar;141(3):1002-1008.
doi: 10.1016/j.jaci.2017.07.036. Epub 2017 Sep 1.

Efficacy and Safety of 4 Months of Sublingual Immunotherapy With Recombinant Mal D 1 and Bet v 1 in Patients With Birch Pollen-Related Apple Allergy

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Randomized Controlled Trial

Efficacy and Safety of 4 Months of Sublingual Immunotherapy With Recombinant Mal D 1 and Bet v 1 in Patients With Birch Pollen-Related Apple Allergy

Tamar Kinaciyan et al. J Allergy Clin Immunol. .

Abstract

Background: Birch pollen-related apple allergy is among the most prevalent food allergies in adolescent/adult subjects and mainly results from sensitization to the major birch pollen allergen Bet v 1 and subsequent cross-reaction with the apple protein Mal d 1. However, specific immunotherapy with birch pollen has inconsistent effects on apple allergy.

Objective: We sought to compare the safety and efficacy of sublingual immunotherapy (SLIT) with 2 formulations containing either rMal d 1 or rBet v 1 on birch pollen-related apple allergy.

Methods: Sixty participants with birch pollen-related apple allergy were randomized to daily sublingual application of placebo (n = 20) or 25 μg of rMal d 1 (n = 20) or rBet v 1 (n = 20) for 16 weeks. Adverse events were regularly recorded. Sublingual challenges with standardized doses of rMal d 1, skin prick tests with recombinant allergens, and measurements of allergen-specific IgE and IgG4 antibodies were performed before and after treatment.

Results: Both formulations caused comparable, mainly local adverse events. No systemic reactions occurred. Compared with the placebo and rBet v 1-treated groups, SLIT with rMal d 1 reduced rMal d 1-induced oral symptoms (P = .001 and P = .038) accompanied by longitudinally reduced rMal d 1-specific cutaneous reactions (P = .022) and enhanced IgG4/IgE ratios (P = .012). SLIT with rBet v 1 neither improved the clinical reactivity to rMal d 1 nor enhanced rMal d 1-specific IgG4/IgE ratios. Participants receiving placebo showed no allergen-specific changes.

Conclusion: Sublingual treatment with a recombinant food allergen was safe and clinically effective, as determined by using standardized challenges. We present a promising approach for the effective treatment of birch pollen-related apple allergy.

Keywords: Bet v 1; Food allergy; IgE; Mal d 1; allergen-specific immunotherapy; birch pollen allergy; birch pollen–related food allergy; recombinant allergens.

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