title: Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR.
abstract: BACKGROUND
  Anti-IgE therapy could be particularly beneficial for patients with concomitant disease as it targets a common factor in both diseases. The aim of this study was to evaluate the efficacy and safety of omalizumab in patients with concomitant moderate-to-severe asthma and persistent allergic rhinitis.
  
  
  METHODS
  This multicentre, randomized, double-blind, parallel-group, placebo-controlled trial evaluated the safety and efficacy of omalizumab. A total of 405 patients (12-74 years) with a stable treatment (>/= 400 microg budesonide Turbuhaler) and >/= 2 unscheduled medical visits for asthma during the past year or >/= 3 during the past 2 years were enrolled. Patients received omalizumab (>/= 0.016 mg/kg/IgE [IU/ml] per 4 weeks) or placebo for 28 weeks.
  
  
  RESULTS
  Fewer patients treated with omalizumab experienced asthma exacerbations (20.6%) than placebo-treated patients (30.1%), P = 0.02. A clinically significant (>/= 1.0 point) improvement in both Asthma Quality of Life Questionnaire and Rhinitis Quality of Life Questionnaire occurred in 57.7% of omalizumab patients compared with 40.6% of placebo patients (P < 0.001). Omalizumab reduced Wasserfallen symptom scores for asthma (P = 0.023), rhinitis (P < 0.001) and the composite asthma/rhinitis scores (P < 0.001) compared with placebo. Serious adverse events were observed in 1.4% of omalizumab-treated patients and 1.5% of placebo-treated patients.
  
  
  CONCLUSIONS
  Omalizumab is well tolerated and effective in preventing asthma exacerbations and improving quality of life in patients with concomitant asthma and persistent allergic rhinitis.
authors.affiliation: Institute of Internal Medicine Pneumology, University of Palermo, Palermo, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Vignola
authors.forename: M
authors.initials: M
authors.lastname: Humbert
authors.forename: J
authors.initials: J
authors.lastname: Bousquet
authors.forename: L-P
authors.initials: LP
authors.lastname: Boulet
authors.forename: S
authors.initials: S
authors.lastname: Hedgecock
authors.forename: M
authors.initials: M
authors.lastname: Blogg
authors.forename: H
authors.initials: H
authors.lastname: Fox
authors.forename: K
authors.initials: K
authors.lastname: Surrey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E