Merck & Co, Inc, Whitehouse Station, New Jersey.
Bernstein Clinical Research Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 10.1016/j.anai.2013.11.018. Epub 2013 Dec 21.
In North America, few studies have evaluated sublingual immunotherapy for allergic rhinitis with or without conjunctivitis (AR/C); pediatric data are sparse. The authors report findings from the largest published immunotherapy trial yet conducted in adults and children.
To evaluate grass sublingual immunotherapy tablet (MK-7243) treatment in subjects with AR/C.
North American subjects (5-65 years old) with grass allergy were randomized 1:1 to once-daily MK-7243 (2,800 BAU Phleum pratense) or placebo. The first dose was given at the investigator's office; subsequent doses were self-administered at home. The primary end point was total combined score (TCS; rhinoconjunctivitis daily symptom score [DSS] plus daily medication score [DMS]) over the entire grass pollen season (GPS). Key secondary end points included entire-season DSS, DMS, peak-season TCS, and rhinoconjunctivitis quality-of-life questionnaire scores. Safety outcomes included adverse events (AEs).
One thousand five hundred one subjects were randomized (85% polysensitized, 25% had asthma). MK-7243 yielded improvements vs placebo of 23% in entire-season TCS (median difference -0.98, P < .001), 29% in peak-season TCS (median difference -1.33, P < .001), 20% in entire-season DSS (median difference -0.64, P = .001), 35% in entire-season DMS (mean difference -0.48, P < .001), and 12% in peak-season rhinoconjunctivitis quality-of-life questionnaire (median difference -0.13, P = .027). Efficacy between children and adults was similar. Most AEs were transient local application-site reactions, with no serious treatment-related AEs or anaphylactic shock. Three subjects (1 placebo, 2 MK-7243) had moderate systemic allergic reactions.
MK-7243 was effective in polysensitized grass-allergic North American children and adults with AR/C in this large trial, confirming previous research.
在北美，很少有研究评估舌下免疫疗法治疗过敏性鼻炎伴或不伴结膜炎（AR/C）；儿科数据较少。作者报告了迄今为止在成人和儿童中进行的最大规模的免疫疗法试验结果。
评估草舌下免疫治疗片（MK-7243）在 AR/C 患者中的治疗效果。
北美草过敏患者（5-65 岁）按 1:1 随机分配至每日一次 MK-7243（Phleum pratense 2800 BAU）或安慰剂。首剂在研究者办公室给予；随后剂量在家中自行给予。主要终点是整个花粉季节（GPS）的总综合评分（TCS；鼻结膜炎每日症状评分[DSS]加每日药物评分[DMS]）。关键次要终点包括整个季节 DSS、DMS、高峰季节 TCS 和鼻结膜炎生活质量问卷评分。安全性结果包括不良事件（AE）。
1501 例患者被随机分配（85%多敏化，25%有哮喘）。与安慰剂相比，MK-7243 可使整个季节 TCS 改善 23%（中位数差异-0.98，P<.001），高峰季节 TCS 改善 29%（中位数差异-1.33，P<.001），整个季节 DSS 改善 20%（中位数差异-0.64，P=.001），整个季节 DMS 改善 35%（平均差异-0.48，P<.001），高峰季节鼻结膜炎生活质量问卷改善 12%（中位数差异-0.13，P=.027）。儿童和成人之间的疗效相似。大多数 AE 为短暂的局部应用部位反应，无严重与治疗相关的 AE 或过敏性休克。3 例患者（1 例安慰剂，2 例 MK-7243）出现中度全身过敏反应。
在这项大型试验中，MK-7243 对多敏化草过敏的北美儿童和成人 AR/C 有效，证实了先前的研究。
