Efficacy and tolerability of anti‐immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR

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 μ g 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. Conclusion: Omalizumab is well tolerated and effective in preventing asthma exacerbations and improving quality of life in patients with concomitant asthma and persistent allergic rhinitis.