舌下含服桦树花粉变应原免疫治疗伴或不伴哮喘的季节性变应性鼻炎结膜炎患者。
Sublingual allergen immunotherapy with a liquid birch pollen product in patients with seasonal allergic rhinoconjunctivitis with or without asthma.
机构信息
Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Germany; Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany.
Upper Airways Research Laboratory, University of Ghent, Ghent, Belgium.
出版信息
J Allergy Clin Immunol. 2019 Mar;143(3):970-977. doi: 10.1016/j.jaci.2018.11.018. Epub 2018 Nov 30.
BACKGROUND
Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III trials for registration.
OBJECTIVE
We sought to investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 allergy units native [AUN]/mL) in adults with birch pollen allergy.
METHODS
A randomized, double-blind, placebo-controlled, parallel-group multicenter trial was conducted in 406 adult patients with moderate-to-severe birch pollen-induced allergic rhinoconjunctivitis with or without mild-to-moderate controlled asthma. Treatment was started 3 to 6 months before the birch pollen season and continued during the season in 40 clinical study centers in 5 European countries. For primary end point assessment, the recommended combined symptom and medication score of the European Academy of Allergy and Clinical Immunology was used. Secondary end points included quality-of-life assessments, immunologic parameters, and safety.
RESULTS
Primary efficacy results demonstrated a significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo after 3 to 6 months of SLIT. Significantly better rhinoconjunctivitis quality-of-life scores (P < .0001) and the patient's own overall assessment of his or her health status, including the visual analog scale score (Euro Quality of Life Visual Analogue Scale; P = .0025), were also demonstrated. In total, a good safety profile of SLIT was observed.
CONCLUSION
This study confirmed both the clinical efficacy and safety of a sublingual liquid birch pollen extract in adults with birch pollen allergy in a pivotal phase III trial (EudraCT: 2013-005550-30; ClinicalTrials.gov: NCT02231307).
背景
舌下过敏原免疫疗法（SLIT）已被证明具有临床疗效和安全性。然而，根据欧洲药品管理局（EMA）目前的监管指导意见，过敏原免疫疗法（AIT）产品必须在关键性 III 期试验中证明其疗效和安全性，方可注册。
目的
我们旨在研究桦树花粉过敏的成年患者接受高剂量舌下桦树花粉液体制剂（40000 过敏单位原生[AUN]/mL）的疗效和安全性。
方法
在 5 个欧洲国家的 40 个临床研究中心，开展了一项随机、双盲、安慰剂对照、平行分组的多中心试验，共纳入 406 例有中重度桦树花粉诱发的过敏性鼻炎，且合并或不合并轻度至中度控制良好的哮喘的成年患者。治疗于桦树花粉季节前 3 至 6 个月开始，并在季节期间持续。主要疗效终点评估采用欧洲变态反应与临床免疫学会（EAACI）的推荐综合症状和药物评分。次要终点包括生活质量评估、免疫学参数和安全性。
结果
主要疗效结果显示，与安慰剂相比，SLIT 治疗 3 至 6 个月后，综合症状和药物评分显著降低（P<0.0001），且具有临床意义（降低 32%）。也显著改善了鼻炎结膜炎生活质量评分（P<0.0001），以及患者自身对健康状况的整体评估，包括视觉模拟评分（Euro Quality of Life Visual Analogue Scale；P=0.0025）。总体而言，SLIT 具有良好的安全性。
结论
这项关键性 III 期试验（EudraCT：2013-005550-30；ClinicalTrials.gov：NCT02231307）证实了桦树花粉液体制剂在成年桦树花粉过敏患者中的临床疗效和安全性。
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