Background

Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease.

Objective

The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma.

Methods

A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial, comprising 3 years of treatment and 2 years of follow-up.

Results

There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet significantly reduced the risk of experiencing asthma symptoms or using asthma medication at the end of trial (odds ratio = 0.66, P < .036), during the 2-year posttreatment follow-up, and during the entire 5-year trial period. Also, grass allergic rhinoconjunctivitis symptoms were 22% to 30% reduced (P < .005 for all 5 years). At the end of the trial, the use of allergic rhinoconjunctivitis pharmacotherapy was significantly less (27% relative difference to placebo, P < .001). Total IgE, grass pollen–specific IgE, and skin prick test reactivity to grass pollen were all reduced compared to placebo.

Conclusions

Treatment with the SQ grass sublingual immunotherapy tablet reduced the risk of experiencing asthma symptoms and using asthma medication, and had a positive, long-term clinical effect on rhinoconjunctivitis symptoms and medication use but did not show an effect on the time to onset of asthma.

中文翻译：

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草花粉过敏儿童5年SQ草舌下免疫治疗片哮喘预防（GAP）试验的结果

背景

过敏免疫疗法针对过敏性鼻结膜炎和过敏性哮喘的免疫学原因，并具有改变过敏性疾病自然过程的潜力。

客观的

主要目的是研究与安慰剂相比，SQ草舌下免疫治疗片对哮喘发生风险的影响。

方法

随机，双盲，安慰剂对照试验共纳入812名儿童（5至12岁），他们具有与临床有关的花粉过敏性结膜炎病史，无病史或哮喘病征象，包括3年的随访时间。治疗和2年的随访。

结果

哮喘发作的时间没有差异，哮喘发作的时间由预先确定的哮喘标准（取决于已记录的肺功能可逆性损伤）（主要终点）确定。在试验结束时，治疗后 2年的随访期间以及治疗期间，使用SQ草舌下免疫治疗片治疗可显着降低出现哮喘症状或使用哮喘药物的风险（几率= 0.66，P <.036）。整个5年的试用期。此外，草过敏性鼻结膜炎的症状减少了22％至30％（ 所有5年的P <.005）。在试验结束时，变应性鼻结膜炎药物疗法的使用显着减少（与安慰剂，P的相对差异为27％ <.001）。与安慰剂相比，总IgE，草花粉特异性IgE和对草花粉的皮肤点刺试验反应性都降低了。

结论

SQ草舌下免疫治疗片治疗可降低出现哮喘症状和使用哮喘药物的风险，并且对鼻结膜炎症状和药物使用具有积极的长期临床效果，但对哮喘发作时间没有影响。