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

L Klimek, J Uhlig, R Mösges, K Rettig, O Pfaar, L Klimek, J Uhlig, R Mösges, K Rettig, O Pfaar

Abstract

Background: Cluster 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.

Methods: In 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 1 week was applied to achieve the maintenance dose which was administered monthly during the study period of 1 year. 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.

Results: Significant 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.

Conclusion: Cluster 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.

Keywords: allergic rhinoconjunctivitis; cluster immunotherapy; glutardialdehyde-polymerized allergen extract; grass pollen; specific subcutaneous immunotherapy.

© 2014 The Authors. Allergy Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Overall participant flow during study.
Figure 2
Figure 2
Mean daily rhinoconjunctivitis total symptom score (RTSS, left Y-axis, upper part) and mean daily total rescue medication score (TRMS, left Y-axis, middle part) in line with the mean daily pollen counts (right Y-axis at the bottom) during the peak pollen period (PPP) and during the pollen season (PS) for the intention-to-treat (ITT) population.
Figure 3
Figure 3
Mean single-symptom scores during peak pollen period (intention-to-treat population), P-values from U-tests between study groups.

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