title: 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.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Klimek
authors.forename: J
authors.initials: J
authors.lastname: Uhlig
authors.forename: R
authors.initials: R
authors.lastname: Mösges
authors.forename: K
authors.initials: K
authors.lastname: Rettig
authors.forename: O
authors.initials: O
authors.lastname: Pfaar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000008:administration & dosage* / Q000276:immunology*; D003233:Conjunctivitis, Allergic / Q000175:diagnosis / Q000276:immunology / Q000628:therapy; D003888:Desensitization, Immunologic / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000276:immunology*; D006109:Poaceae / Q000737:chemistry / Q000276:immunology*; D011058:Pollen / Q000737:chemistry / Q000276:immunology*; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000485:Allergens; D010936:Plant Extracts
keywords: allergic rhinoconjunctivitis; cluster immunotherapy; glutardialdehyde-polymerized allergen extract; grass pollen; specific subcutaneous immunotherapy