Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis
Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis
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DOI：
10.1016/j.jaci.2011.06.022
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发表时间：
2011-09-01
影响因子：
14.2
通讯作者：
Malling, Hans-Jorgen
中科院分区：
文献类型：
--
作者：
Didier, Alain;Worm, Margitta;Malling, Hans-Jorgen
背景：季节性过敏性鼻结膜炎影响数百万人。过敏原舌下免疫疗法（SLIT）的有效性在以前的短期研究中得到了证实。目的：我们试图评估两种给药方案的持续疗效，即300 IR的季节前和季节同时治疗。（反应性指数）5-草花粉SLIT片剂（Oralair）与安慰剂相比，通过使用第3季草花粉成人的平均校正症状评分（AAdSS）进行评估-方法：633例患者在花粉季节前2个月或4个月进行治疗，然后在花粉季节期间连续3个季节进行活性或安慰剂治疗。主要结局是连续3个治疗季节后的AAdSS，即根据补救药物使用情况调整的症状评分。次要结果是症状和补救药物评分，生活质量和安全性assessment.Results：平均AAdSS分别减少了36.0%和34.5%，在第3季的2个月和4个月前和同季积极治疗组，分别与安慰剂组相比（P <0.0001）。观察到总症状评分和ISS以及药物评分降低，与第3季安慰剂组相比，两个活性组的生活质量显著改善。大多数治疗后出现的不良事件是局部反应预期与SLIT，减少数量和强度在每个治疗season.Conclusions：持续的疗效，2个月和4个月前和同季节治疗的300 IR片剂超过3花粉季节，减少症状和救援药物的使用。治疗耐受性良好。在3个季节中，不良事件的数量和强度都有所下降。（J Allergy Clin Immunol 2011;128：559-66.）
Background: Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy (SLIT) was demonstrated in previous short-term studies.Objectives: We sought to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR (index of reactivity) 5-grass-pollen SLIT tablets (Oralair) compared with placebo assessed by using the average adjusted symptom score (AAdSS) at season 3 in adults with grass pollen-induced rhinoconjunctivitis.Methods: Six hundred thirty-three patients were treated for either 2 or 4 months before and then during the grass pollen season with active or placebo treatment for 3 consecutive seasons. The primary outcome was the AAdSS, a symptom score adjusted for rescue medication use, after 3 consecutive treatment seasons. Secondary outcomes were symptoms and rescue medication score, quality-of-life, and safety assessments.Results: The mean AAdSS was reduced by 36.0% and 34.5% at season 3 in the 2- and 4-month pre- and coseasonal active treatment groups, respectively, compared with that in the placebo group (P < .0001 for both). Reductions were observed in total symptom scores and ISSs and the medication score, with a marked improvement in quality of life for both active groups compared with the placebo group at season 3. Most treatment-emergent adverse events were local reactions expected with SLIT, decreasing in number and intensity in each treatment season.Conclusions: Sustained efficacy of 2- and 4-month pre- and coseasonal treatment with the 300 IR tablet over 3 pollen seasons was demonstrated, with reduction in symptoms and rescue medication use. The treatment was well tolerated. Adverse events decreased in number and intensity over the 3 seasons. (J Allergy Clin Immunol 2011;128:559-66.)