title: Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid.
abstract: BACKGROUND
  The clinical efficacy and safety of a six-grass pollen allergoid has been studied. The advent of more exacting clinical guidelines and a better appreciation of the possible mechanisms of treatment prompted this reappraisal.
  
  
  METHODS
  A 2-year double-blind multicentre placebo-controlled phase 3 clinical trial was undertaken in 154 patients suffering symptoms of rhinoconjunctivitis with or without asthma (GINA I or II). Therapy comprised two consecutive preseasonal short-courses of subcutaneous injections using a grass pollen allergoid adsorbed to aluminium hydroxide.
  
  
  RESULTS
  A combined symptom and medication score (SMS) was used as the primary end-point for clinical efficacy. SMS from the first year showed a significant difference of 26.6% between the two study groups (P=0.026) and this was improved after the second year when there was a 48.4% difference in SMS between active and placebo treatment in favour of the allergoid (P = 0.018). Highly significant increases in grass pollen allergen-specific IgG1 and IgG4 antibody concentrations were measured in association with active treatment. Allergen tolerance was increased as judged by a conjunctival provocation test and significant improvements in quality of life were documented using a standardized questionnaire. The allergoid was well tolerated.
  
  
  CONCLUSIONS
  The grass pollen allergoid was shown to be safe and clinically efficacious in the management of hay fever with or without asthma (GINA I or II).
authors.affiliation: Guy's, King's and St Thomas's School of Medicine, London, UK.
authors.forename: C J
authors.initials: CJ
authors.lastname: Corrigan
authors.forename: J
authors.initials: J
authors.lastname: Kettner
authors.forename: C
authors.initials: C
authors.lastname: Doemer
authors.forename: O
authors.initials: O
authors.lastname: Cromwell
authors.forename: A
authors.initials: A
authors.lastname: Narkus
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D000080384:Allergoids; D000918:Antibody Specificity; D001249:Asthma / Q000150:complications / Q000628:therapy; D003231:Conjunctivitis / Q000097:blood / Q000150:complications / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D006109:Poaceae / Q000276:immunology; D011058:Pollen / Q000276:immunology; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000097:blood / Q000628:therapy*; D006113:United Kingdom; D014612:Vaccines; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000485:Allergens; D000080384:Allergoids; D007074:Immunoglobulin G; D010936:Plant Extracts; D014612:Vaccines; D014614:Vaccines, Synthetic; C099681:allergovit; D007073:Immunoglobulin E