Clinical and translational allergy
Short-Course Subcutaneous Immunotherapy With Mannan-Conjugated Birch Pollen Allergoids: Consistent Clinical and Immunological Improvements
By Raskopf E, Passamera S, Klimek L and 12 others.
Abstract
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.