High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: A double-blind, placebo-controlled study

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

“…As a consequence of this imprecise definition, divergent definitions of the 'clinically justified thresholds' for TSS have been elaborated, mostly in recent studies on sublingual AIT (41)(42)(43)(44)(45)(46)(47). Although this measure may allow an approximation of the extreme values or 'range of severity' and a good correlation with the TSS and the RQLQ, it is also influenced by disadvantages hampering symptom/MS as outlined above.…”

“…Both 'well days' and 'bad/severe days' have been proposed as secondary and exploratory outcomes (41)(42)(43)(44)(45)(46)(47)(48). The EMA has recommended implementing a report of efficacy in the guideline with the evaluation of 'days with symptom control' as defined as 'days without intake of rescue medication and a symptom score below a predefined and clinically justified threshold' (6).…”

Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis

“…[8][9][10]12 As importantly, a review of the recent literature 7,17,22,23 shows that the largest reported clinical studies of SLIT-liquid are less than half the size of our trial. Therefore, our study findings represent a major statement, not only for ragweed but also for SLIT as an entity.…”

Allergen-Specific Immunotherapy in Children. Standardizing the Efficacy Evaluation Approaches

“…Количество дней с/без симптомов Подсчет дней без симптомов («хороших») и дней с выраженными клиническими проявлениями («пло-хих/тяжелых») используется как вспомогательный кри-терий [27][28][29][30][31][32][33][34]. Оптимально проводить одновременно оценку количества дней без клинических проявлений, числа дней с контролируемыми проявлениями, дней без приема лекарственных препаратов неотложной помощи параллельно со шкалами оценки симптомов, которые были приведены выше [8].…”