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.

中文翻译：

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重组Mal d 1和Bet v 1舌下免疫疗法对桦木花粉相关苹果过敏患者4个月的疗效和安全性

背景

桦树花粉相关的苹果过敏症是青少年/成人受试者中最普遍的食物过敏症，主要是由于对主要桦树花粉过敏原Bet v 1的敏感性以及随后与苹果蛋白Mal d 1的交叉反应所致。桦木花粉对苹果过敏的作用不一致。

客观的

我们试图比较两种含rMal d 1或rBet v 1的制剂对桦木花粉相关的苹果过敏的舌下免疫疗法（SLIT）的安全性和有效性。

方法

60名桦树花粉相关苹果过敏的参与者被随机分配到每天舌下应用安慰剂（n = 20）或25μgrMal d 1（n = 20）或rBet v 1（n = 20），持续16周。定期记录不良事件。在治疗前后，对rMal d 1标准化剂量的舌下挑战，重组过敏原的皮肤点刺试验以及过敏原特异性IgE和IgG ₄抗体的测量。

结果

两种制剂均引起可比较的，主要是局部不良事件。没有发生全身反应。与安慰剂和rBet v 1治疗组相比，具有rMal d 1的SLIT减轻了rMal d 1引起的口腔症状（P  = .001和P  = .038），同时纵向减少了rMal d 1特异性皮肤反应（P  = .022）和增强的IgG ₄ / IgE比（P  = .012）。带有rBet v 1的SLIT既不能提高对rMal d 1的临床反应性，也不能提高rMal d 1特异性IgG ₄ / IgE的比率。接受安慰剂的参与者未显示过敏原特异性变化。

结论

通过使用标准化挑战确定，用重组食品过敏原进行舌下治疗是安全且临床有效的。我们为有效治疗桦木花粉相关的苹果过敏症提供了一种有前途的方法。