Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

Allergy
Margitta WormS Zielen

Abstract

The Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX® Quattro Plus 1.0 ml Birch 100%) is an effective, well-tolerated short course subcutaneous immunotherapy. We performed 2 phase II studies to determine its optimal cumulative dose. The studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012-004336-28 PQBirch203 and 2015-000984-15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season. Conjunctival Provocation Tests were performed at screening, baseline and 3-4 weeks after completing treatment, to quantify the reduction in Total Symptom Scores (as the primary endpoint) with each cumulative dose. Multiple Comparison Procedure and Modeling analysis was used to test for the dose response, shape of the curve and estimation of the median effective dose (ED50 ), a measure of potency. Statistically significant dose responses (P < .01 & .001) were seen, respectively. The highest cumulative dose in PQBirch204 (27 300 standardized units [SU]) approached a plateau. Potency of the PQBirch was demonstrated by an ED50 2723 SU, just over half the current dose. Prevalence of treatment-emergent adverse events ...Continue Reading

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Citations

Oct 30, 2018·Allergy·Oliver PfaarLuo Zhang
Jun 25, 2019·Journal of Applied Toxicology : JAT·Paul BaldrickChris Gray
Aug 30, 2019·Current Opinion in Allergy and Clinical Immunology·Martin Penagos, Stephen R Durham
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Sep 10, 2020·Allergology International : Official Journal of the Japanese Society of Allergology·Umut C KucuksezerCezmi A Akdis

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Software Mentioned

Interactive Web Response System ( IWRS )
Multiple Comparison Procedure and Modeling ( MCP ‐ Mod )
PQBirch
MCP

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