Efficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis.
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.
Kuehr
Joachim
J
University Children's Hospital, Freiburg, Germany.
Brauburger
Jens
J
Zielen
Stefan
S
Schauer
Uwe
U
Kamin
Wolfgang
W
Von Berg
Andrea
A
Leupold
Wolfgang
W
Bergmann
Karl-Christian
KC
Rolinck-Werninghaus
Claudia
C
Gräve
Michael
M
Hultsch
Thomas
T
Wahn
Ulrich
U
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
D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E