Clinical and translational allergy · 2026
Short-Course Subcutaneous Immunotherapy With Mannan-Conjugated Birch Pollen Allergoids: Consistent Clinical and Immunological Improvements.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Raskopf Esther, Passamera Sofia, Klimek Ludger, Pfaar Oliver, Neuhof Christian, Rybachuk Anna, Katzke Nadine, Sahin Hacer, Allekotte Silke, Mösges Ralph, Day Laura, Subiza José Luis, Casanovas Miguel, Cuevas Mandy, Del Pozo Sandra
Аннотация
BACKGROUND: The mannan-conjugated birch pollen polymerised allergoid EP-088_T502 has previously been shown to reduce allergic symptoms and anti-allergic medication use during the birch pollen season. This confirmatory phase III trial aimed to evaluate the efficacy, safety, tolerability, and immunologic effects of EP-088_T502 administered as eight subcutaneous injections over six pre-seasonal treatment visits.
METHODS: In this double-blind, placebo-controlled (DBPC) trial, 278 participants with birch pollen-induced allergic rhinoconjunctivitis (ARC) received either placebo or a cumulative dose of 28,000 mannan therapeutic units (mTU) of EP-088_T502. The primary efficacy endpoint was the combined symptom and medication score (CSMS) during the peak birch pollen season. Safety, tolerability, health-related quality of life (QoL), and immunologic parameters were also assessed.
RESULTS: In the full analysis set (FAS), EP-088_T502 significantly reduced the CSMS during the peak birch pollen season compared with placebo (mean absolute difference [MAD] -0.31; 95% confidence interval [CI], -0.56 to -0.05; p = 0.0169). In the per-protocol (PP) and complete-case sets, the corresponding MADs were -0.36 (p = 0.012) and -0.51 (p = 0.013), respectively. Health-related QoL improved by 20% in the EP-088_T502 group compared with placebo during the peak season (p < 0.005). EP-088_T502 increased Bet v 1-specific immunoglobulin G4 (IgG4) levels after treatment compared with placebo (6.4-fold; p < 0.0001). The Bet v 1-specific immunoglobulin E (IgE)/IgG4 ratio was reduced by 73% from baseline and by 69% compared with placebo (both p < 0.0001). Thirteen systemic allergic reactions occurred, including one grade III systemic reaction considered related to EP-088_T502.
CONCLUSIONS: EP-088_T502 significantly improved symptom and medication scores in participants with birch pollen-induced ARC and induced a substantial Bet v 1-specific IgG4 response. The 28,000 mTU regimen induced a substantial immunological response and showed an acceptable safety and tolerability profile.
METHODS: In this double-blind, placebo-controlled (DBPC) trial, 278 participants with birch pollen-induced allergic rhinoconjunctivitis (ARC) received either placebo or a cumulative dose of 28,000 mannan therapeutic units (mTU) of EP-088_T502. The primary efficacy endpoint was the combined symptom and medication score (CSMS) during the peak birch pollen season. Safety, tolerability, health-related quality of life (QoL), and immunologic parameters were also assessed.
RESULTS: In the full analysis set (FAS), EP-088_T502 significantly reduced the CSMS during the peak birch pollen season compared with placebo (mean absolute difference [MAD] -0.31; 95% confidence interval [CI], -0.56 to -0.05; p = 0.0169). In the per-protocol (PP) and complete-case sets, the corresponding MADs were -0.36 (p = 0.012) and -0.51 (p = 0.013), respectively. Health-related QoL improved by 20% in the EP-088_T502 group compared with placebo during the peak season (p < 0.005). EP-088_T502 increased Bet v 1-specific immunoglobulin G4 (IgG4) levels after treatment compared with placebo (6.4-fold; p < 0.0001). The Bet v 1-specific immunoglobulin E (IgE)/IgG4 ratio was reduced by 73% from baseline and by 69% compared with placebo (both p < 0.0001). Thirteen systemic allergic reactions occurred, including one grade III systemic reaction considered related to EP-088_T502.
CONCLUSIONS: EP-088_T502 significantly improved symptom and medication scores in participants with birch pollen-induced ARC and induced a substantial Bet v 1-specific IgG4 response. The 28,000 mTU regimen induced a substantial immunological response and showed an acceptable safety and tolerability profile.