Patients with allergic asthma (AA) frequently experience concomitant perennial allergic rhinitis (PAR). Omalizumab, a humanized monoclonal anti-IgE antibody, improves symptoms and disease control in patients with AA or PAR. In this study, we evaluated the efficacy of omalizumab in patients with concomitant AA and PAR.
This was a 28-week, randomized, double-blind, placebo-controlled multicenter trial of 405 patients with moderate–severe AA and concomitant moderate–severe PAR. Patients (12–74 years) were randomized to receive either omalizumab (n=209) [at least 0.016mg/kg/IgE(IU/mL) per 4 weeks] or placebo (n=196) for 28 weeks, in addition to current therapies (inhaled budesonide Turbuhaler [≥400 μg/day] plus optional long-acting β2-agonist and/or nasal steroids). Efficacy parameters included AA and PAR clinical symptom scores (40 and 44 point scale for asthma and rhinitis, respectively), investigator global evaluations of treatment effectiveness, asthma exacerbations, and asthma-and-rhinitis-related quality of life (QoL).
Omalizumab resulted in significant reductions from baseline in both asthma and rhinitis clinical symptom scores at study end. Asthma symptom scores decreased by an (adjusted) mean of 8.4 points (baseline 16.4) with omalizumab compared with a decrease of 6.6 (baseline 16.2) for placebo (p<0.05). Investigators rated asthma symptom control as excellent/good in 59.3% omalizumab-treated patients compared with 41.3% patients in the placebo group (p<0.001). Rhinitis symptom scores decreased by an (adjusted) mean of 9.3 points (baseline 21.9) with omalizumab compared with 5.8 (baseline 21.8) for placebo (p<0.001). More omalizumab patients had their rhinitis symptom control rated as excellent/good by investigators than placebo (54.5% vs 26.5%, p<0.001). Omalizumab decreased the asthma exacerbation rate by 39% compared with placebo (p<0.05) and improved combined asthma-and-rhinitis-related QoL scores at study end compared with placebo (p<0.001).CONCLUSIONS: Omalizumab provides parallel improvements in asthma and rhinitis symptoms in patients with both moderate–severe allergic asthma and perennial allergic rhinitis.
Anti-IgE therapy with omalizumab is an effective add-on therapy in patients with co-morbid AA and PAR.
L. Boulet, Research funded by Novartis Pharma AG and Genentech, Industry.