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Efficacy and safety of 4 months of sublingualimmunotherapy with recomb…

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Efficacy and safety of 4 months of sublingualimmunotherapy with recombinant Mal d 1 and Bet v 1in patients with birch pollen–related apple allergy
 
Tamar Kinaciyan, MD,aBirgit Nagl,bSandra Faustmann,bFlorian Frommlet, PhD,cStephan Kopp, PhD,dMartin Wolkersdorfer, PhD,eStefan W€ohrl, MD,fKatharina Bastl, PhD,gHans Huber, PhD,dUwe Berger, PhD,gandBarbara Bohle, PhD
(J Allergy Clin Immunol 2018;141:1002-8)
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Background: Birch pollen–related apple allergy is among themost prevalent food allergies in adolescent/adult subjects andmainly results from sensitization to the major birch pollenallergen Bet v 1 and subsequent cross-reaction with the appleprotein Mal d 1. However, specific immunotherapy with birchpollen has inconsistent effects on apple allergy.
Objective: We sought to compare the safety and efficacy ofsublingual immunotherapy (SLIT) with 2 formulationscontaining either rMal d 1 or rBet v 1 on birch pollen–relatedapple allergy.Methods: Sixty participants with birch pollen–related appleallergy were randomized to daily sublingual application ofplacebo (n520) or 25mg of rMal d 1 (n520) or rBet v 1(n520) for 16 weeks. Adverse events were regularly recorded. Sublingual challenges with standardized doses of rMal d 1, skinprick tests with recombinant allergens, and measurements ofallergen-specific IgE and IgG4antibodies were performedbefore and after treatment.
Results: Both formulations caused comparable, mainly localadverse events. No systemic reactions occurred. Compared withthe placebo and rBet v 1–treated groups, SLIT with rMal d 1reduced rMal d 1–induced oral symptoms (P5.001 andP5.038) accompanied by longitudinally reduced rMald 1–specific cutaneous reactions (P5.022) and enhancedIgG4/IgE ratios (P5.012). SLIT with rBet v 1 neither improvedthe clinical reactivity to rMal d 1 nor enhanced rMal d 1–specific IgG4/IgE ratios. Participants receiving placebo showedno allergen-specific changes.
Conclusion: Sublingual treatment with a recombinant foodallergen was safe and clinically effective, as determined by usingstandardized challenges. We present a promising approachfor the effective treatment of birch pollen–related apple allergy.

 

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