Universität zu Köln

Klimek, L., Uhlig, J., Moesges, R., Rettig, K. and Pfaar, O. (2014). A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol. Allergy, 69 (12). S. 1629 - 1639. HOBOKEN: WILEY. ISSN 1398-9995

Full text not available from this repository.

Abstract

BackgroundCluster immunotherapy represents an interesting alternative to conventional up-dosing schedules because it allows achieving the maintenance dose within a shorter time interval. In this study, the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized, double-blind, placebo-controlled, multicenter study. MethodsIn total, 121 patients with allergic rhinoconjunctivitis due to grass pollen were randomized 1:1 to verum or placebo group. A short cluster up-dosing schedule of only 1week was applied to achieve the maintenance dose which was administered monthly during the study period of 1year. Total combined symptom and medication score (TCS) was defined as primary outcome parameter. Secondary outcome parameters were individual symptom and medication scores, well days,' global improvement as well as immunological effects and nasal allergen challenge. The safety profile was evaluated based on the European academy of allergy and clinical immunology grading system. ResultsSignificant reduction in the verum compared to the placebo group (intention-to-treat, population, verum: n=55; placebo: n=47) was found regarding TCS (P=0.005), rhinoconjunctivitis total symptom score (RTSS, P=0.006), and total rescue medication score (TRMS, P=0.002). Additionally, secondary outcomes such as well days,' nasal challenge results, and increase of specific IgG4 were in favor of the active treatment. All systemic adverse reactions (0.8% of all injections in the verum group) were of mild intensity. No severe reactions related to the study medication were observed. ConclusionCluster immunotherapy with high polymerized grass pollen extracts resulted in significant clinical efficacy and has been shown to be a safe treatment for grass pollen-allergic patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Klimek, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Uhlig, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moesges, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rettig, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfaar, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-422047
DOI:	10.1111/all.12513
Journal or Publication Title:	Allergy
Volume:	69
Number:	12
Page Range:	S. 1629 - 1639
Date:	2014
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1398-9995
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ALLERGEN-SPECIFIC IMMUNOTHERAPY; SUBLINGUAL IMMUNOTHERAPY; RHINOCONJUNCTIVITIS; SCHEDULES; RHINITIS; ASTHMA; TRIALS; STANDARDIZATION; RECOMMENDATIONS; ORGANIZATION Multiple languages Allergy; Immunology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42204