Cedar pollinosis (CP), a common form of seasonal allergic rhinitis (AR), is a substantial medical problem in Japan due to its high prevalence and severe symptoms. Omalizumab (anti-IgE therapy) has previously proven effective in CP/AR, but no studies for inadequately controlled severe CP/AR despite standard-of-care (SoC) have been conducted.
To determine the efficacy of omalizumab added to SoC in patients with inadequately controlled severe CP in a randomized, double-blinded, placebo-controlled, phase III study.
Severe adult/adolescent CP patients whose symptoms were inadequately controlled despite nasal corticosteroids plus one or more oral medications in the previous two seasons were randomized to receive omalizumab (n = 162) or placebo (n = 175). All patients received concomitant antihistamines and nasal corticosteroids as SoC. The primary endpoint was the mean nasal symptom score during the severe symptom period. Secondary endpoints included mean ocular symptom score, quality-of-life, and safety.
The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively. Differences in scores for individual components of nasal and ocular symptoms were also statistically and clinically significant. SoC + Omalizumab also improved QoL scores as overall and in all domains. No unexpected safety signals were observed.
In severe CP patients, omalizumab added to SoC demonstrated consistent efficacy in improving symptoms and QoL, and was well-tolerated. These results indicate omalizumab could be a promising therapeutic option for severe CP/AR.
Copyright © 2020. Published by Elsevier Inc.