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. Issue 12 (6th October 2014)

• Record Type: Journal Article
• Authors: Klimek, L.; Uhlig, J.; Mösges, R.; Rettig, K.; Pfaar, O.
• Is Part Of: Allergy. Volume 69:Issue 12(2014:Dec.)
• Page Start: 1629
• Page End: 1638
• Publication Date: 2014-10-06
• Subjects: Allergy -- Periodicals; 616.97
• DOI: 10.1111/all.12513
• Languages: English
• ISSNs: 0105-4538

Abstract

<abstract abstract-type="main" id="all12513-abs-0001"> <title>Abstract</title> <sec id="all12513-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="all12513-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="all12513-sec-0003" sec-type="section"> <title>Results</title> <p>Significant reduction in the verum compared to the placebo group (intention‐to‐treat, population, verum: <italic>n</italic> = 55; placebo: <italic>n</italic> = 47) was found regarding TCS (<italic>P</italic> = 0.005), rhinoconjunctivitis total symptom score (RTSS, <italic> P</italic> = 0.006), and total rescue medication score (TRMS, <italic> P</italic> = 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.</p> </sec> <sec id="all12513-sec-0004" sec-type="section"> <title>Conclusion</title> <p>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.</p> </sec> </abstract>