Universität zu Köln

Worm, M., Higenbottam, T., Pfaar, O., Moesges, R., Aberer, W., Gunawardena, K., Wessiepe, D., Lee, D., Kramer, M. F., Skinner, M., Lees, B. and Zielen, S. (2018). Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy. Allergy, 73 (9). S. 1812 - 1823. HOBOKEN: WILEY. ISSN 1398-9995

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Abstract

BackgroundThe Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX (R) 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. MethodsThe 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. ResultsStatistically 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 was similar for active doses, most being short-lived and mild. Compliance was over 85% in all groups. ConclusionIncreasing the cumulative dose of PQBirch 5.5-fold from 5100 to 27 300 SU achieved an absolute point difference from placebo of 1.91, a relative difference 32.3% and an increase in efficacy of 50%, without compromising safety. The cumulative dose response was confirmed to be curvilinear in shape.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Worm, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Higenbottam, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfaar, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moesges, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Aberer, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gunawardena, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wessiepe, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lee, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kramer, M. F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Skinner, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lees, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zielen, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-175202
DOI:	10.1111/all.13478
Journal or Publication Title:	Allergy
Volume:	73
Number:	9
Page Range:	S. 1812 - 1823
Date:	2018
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1398-9995
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CONJUNCTIVAL PROVOCATION TESTS; MONOPHOSPHORYL-LIPID-A; SUBLINGUAL IMMUNOTHERAPY; SUBCUTANEOUS IMMUNOTHERAPY; RHINOCONJUNCTIVITIS; EFFICACY; PLACEBO; TOLERANCE; MONOTONE; ADJUVANT Multiple languages Allergy; Immunology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/17520