Grouin J-M, Vicaut E, Devillier P
INSERM 1219, University of Rouen, Rouen, France.
Clinical Research Unit Saint-Louis Lariboisière Fernand-Widal, University of Paris-Diderot, Paris, France.
Clin Exp Allergy. 2017 Feb;47(2):254-263. doi: 10.1111/cea.12845. Epub 2016 Dec 2.
Over the past decade, regulatory bodies and scientific societies recommended, as primary efficacy outcome, a score that reflects both symptom severity and use of rescue medication for clinical trials in allergy immunotherapy (AIT).
We sought to compare the results obtained with two subject-specific scores, the Combined Score (CS) and the Adjusted Symptom Score (AdSS), for assessment of AIT in seasonal allergic rhinoconjunctivitis due to birch and grass pollen allergens.
CS and AdSS were evaluated in subjects receiving a 300IR dose of allergen extract daily, by sublingual route, in four clinical trials with the 5-grass pollen tablet (NCT00367640, NCT00409409, NCT00955825 and NCT00418379) and one with the birch pollen solution (NCT01731249). The CS is derived from the Rhinoconjunctivitis Total Symptom Score (RTSS) and the Rescue Medication Score (RMS) giving equal weight to symptoms and medication use. The AdSS is a symptom score adjusting for rescue medication use. Efficacy end-points were analysed using an analysis of covariance linear model.
In all trials, despite the different constructs of the two scores, Combined Score or Adjusted Symptom Score were similarly reduced in the 300IR group compared to the placebo group. Treatment effect was consistently demonstrated with both scores, CS and AdSS, used as either daily scores or average of the daily scores over the pollen season. Minor differences with the same statistical conclusions were observed between the results, leading to the same interpretation.
The two scores, combined and adjusted scores, for evaluation of clinical efficacy of AIT have led to similar results, with similar statistical conclusions and similar interpretation.
在过去十年中，监管机构和科学协会推荐将一个既能反映症状严重程度又能反映急救药物使用情况的评分作为变应原免疫疗法（AIT）临床试验的主要疗效指标。
我们试图比较两种针对个体的评分，即综合评分（CS）和调整症状评分（AdSS），用于评估桦树和草花粉过敏原引起的季节性过敏性鼻结膜炎的AIT效果。
在四项使用5种草花粉片剂（NCT00367640、NCT00409409、NCT00955825和NCT00418379）的临床试验以及一项使用桦树花粉溶液（NCT01731249）的试验中，对每日通过舌下途径接受300IR剂量变应原提取物的受试者进行CS和AdSS评估。CS由鼻结膜炎总症状评分（RTSS）和急救药物评分（RMS）得出，对症状和药物使用给予同等权重。AdSS是针对急救药物使用情况进行调整的症状评分。使用协方差线性模型分析疗效终点。
在所有试验中，尽管两种评分的构成不同，但与安慰剂组相比，300IR组的综合评分或调整症状评分均有相似程度的降低。使用CS和AdSS这两种评分作为每日评分或花粉季节每日评分的平均值时，均持续显示出治疗效果。结果之间观察到存在微小差异但统计结论相同，导致相同的解读。
用于评估AIT临床疗效的两种评分，即综合评分和调整评分，得出了相似的结果，具有相似的统计结论和相似的解读。
