title: Efficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis.
abstract: BACKGROUND
  Specific immunotherapy (SIT) and treatment with monoclonal anti-IgE antibody have complementary modes of action.
  
  
  OBJECTIVE
  The purpose of this study was to determine whether combined therapy could provide better efficacy than either treatment alone.
  
  
  METHODS
  We conducted a randomized, double-blinded trial to assess the efficacy and safety of subcutaneously administered anti-IgE (omalizumab) or placebo in children and adolescents with seasonal allergic rhinitis in both a birch pollen season and a grass pollen season (sequential seasons together lasting an average of 84 days). There were 4 treatment arms. Each subject was started on SIT-birch or SIT-grass, and anti-IgE or placebo was started before and maintained during the anticipated pollen seasons (a total of 24 weeks). The primary efficacy variable was symptom load, the sum of daily symptom severity score plus rescue medication use.
  
  
  RESULTS
  A total of 221 subjects (intent-to-treat population) aged 6 to 17 years were analyzed for efficacy. Combination therapy reduced symptom load over the 2 pollen seasons by 48% (P <.001) over SIT alone. When analyzed separately by season, the 2 groups receiving unrelated SIT were considered placebo controls. In the grass season, symptom loads were as follows: unrelated (birch) SIT + placebo, 0.89 (reference value); unrelated (birch) SIT + anti-IgE, 0.49 (-45%); SIT-grass + placebo, 0.61 (-32%); SIT-grass + anti-IgE, 0.26 (-71%).
  
  
  CONCLUSIONS
  Anti-IgE therapy conferred a protective effect independent of the type of allergen. Additional clinical benefit was demonstrated in both pollen seasons, whether there was coverage by SIT or not. This combination might prove useful for the treatment of allergic rhinitis, particularly for polysensitized patients.
authors.affiliation: University Children's Hospital, Freiburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Kuehr
authors.forename: Jens
authors.initials: J
authors.lastname: Brauburger
authors.forename: Stefan
authors.initials: S
authors.lastname: Zielen
authors.forename: Uwe
authors.initials: U
authors.lastname: Schauer
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kamin
authors.forename: Andrea
authors.initials: A
authors.lastname: Von Berg
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Leupold
authors.forename: Karl-Christian
authors.initials: KC
authors.lastname: Bergmann
authors.forename: Claudia
authors.initials: C
authors.lastname: Rolinck-Werninghaus
authors.forename: Michael
authors.initials: M
authors.lastname: Gräve
authors.forename: Thomas
authors.initials: T
authors.lastname: Hultsch
authors.forename: Ulrich
authors.initials: U
authors.lastname: Wahn
mesh_terms: D000293:Adolescent; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D029662:Betula / Q000009:adverse effects / Q000276:immunology; D002648:Child; D003131:Combined Modality Therapy; D003888:Desensitization, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D008297:Male; D000069444:Omalizumab; D006109:Poaceae / Q000009:adverse effects / Q000276:immunology; D011058:Pollen / Q000009:adverse effects / Q000276:immunology*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E