Efficacy of omalizumab, an anti-IgE antibody, in patients with concomitant moderate-severe allergic asthma and persistent allergic rhinitis

Abstract

Rationale This is the first study designed specifically to evaluate the efficacy of omalizumab in patients with concomitant moderate-severe allergic asthma (AA) and persistent allergic rhinitis (PAR). Methods 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 0.016 mg/kg/IgE [IU/mL] per 4 weeks) or placebo (n=196) for 28 weeks, in addition to conventional therapies (inhaled budesonide Turbuhaler [>=400 μg/day] plus optional long-acting beta2-agonist [LABA] and/or nasal steroids). Efficacy parameters included asthma exacerbations (asthma worsening requiring systemic steroids or doubling of baseline dose of inhaled steroid), combined asthma and rhinitis clinical symptom score (84 point scale) and pulmonary function (PEF). Results Omalizumab-treated patients experienced fewer exacerbations (0.25 [mean]) compared to placebo-treated patients (0.40 [mean]; p<0.05). Concomitant LABA use was similar in both groups (omalizumab 41.1%, placebo 36.2%) and did not affect omalizumab's ability to reduce exacerbations (exacerbation rate ratio 0.66 +LABAs, 0.59 −LABAs). The combined symptom score decreased by an (adjusted) mean of 17.8 points (baseline 38.3) with omalizumab compared with a 12.4 decrease (baseline 38.1) for placebo ( p<0.001). There was a significant difference in mean morning PEF with omalizumab compared with placebo at all assessments during treatment (treatment difference 11 L/min, p<0.001). Conclusions Omalizumab effectively controls combined asthma and rhinitis symptoms in patients with concomitant moderate-severe allergic asthma and persistent allergic rhinitis. Omalizumab significantly reduces asthma exacerbations and improves PEF.