title: Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy.
abstract: BACKGROUND
  Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended.
  
  
  OBJECTIVE
  To investigate the efficacy of treatment with the grass tablet on grass pollen-induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children.
  
  
  METHODS
  A total of 253 children age 5 to 16 years, with grass pollen-induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores.
  
  
  RESULTS
  The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was oral pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related.
  
  
  CONCLUSIONS
  Immunotherapy with the grass tablet reduced grass pollen-induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.
authors.affiliation: Experimental Pneumonology, Ruhr-University Bochum, Bergmannsheil-University-Clinics, Bochum, Germany. albrecht.bufe@rub.de
authors.forename: Albrecht
authors.initials: A
authors.lastname: Bufe
authors.forename: Peter
authors.initials: P
authors.lastname: Eberle
authors.forename: Eivy
authors.initials: E
authors.lastname: Franke-Beckmann
authors.forename: Jürgen
authors.initials: J
authors.lastname: Funck
authors.forename: Martin
authors.initials: M
authors.lastname: Kimmig
authors.forename: Ludger
authors.initials: L
authors.lastname: Klimek
authors.forename: Roland
authors.initials: R
authors.lastname: Knecht
authors.forename: Volker
authors.initials: V
authors.lastname: Stephan
authors.forename: Bente
authors.initials: B
authors.lastname: Tholstrup
authors.forename: Christian
authors.initials: C
authors.lastname: Weisshaar
authors.forename: Friedrich
authors.initials: F
authors.lastname: Kaiser
mesh_terms: D000293:Adolescent; D052179:Antigens, Plant / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D006109:Poaceae / Q000009:adverse effects / Q000276:immunology; D011058:Pollen / Q000009:adverse effects / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D013997:Time Factors
chemical_list: D052179:Antigens, Plant