Add-on omalizumab, a new treatment option for allergic rhinitis despite standard-of-care
Published online: May 10, 2020
Allergic rhinitis (AR) is one of the most common and increasingly prevalent diseases worldwide, which greatly reduces quality-of-life due to the accompanying nasal and ocular symptoms. Cedar pollinosis (CP), a form of seasonal AR, is a common and substantial problem in Japan owing to its high prevalence and severe symptoms and there is a clear need for new treatments in patients with inadequately controlled severe CP despite standard-of-care (SoC). Omalizumab (anti-IgE therapy) has previously proven effective in AR/CP, however the effect of omalizumab for these severe patients added to SoC is unknown.
In a recent article published in The Journal of Allergy and Clinical Immunology: In Practice, Okubo et al evaluated the efficacy and safety of omalizumab added to SoC in patients with inadequately controlled CP in a randomized, double-blinded, placebo-controlled, phase III study. Adults/adolescents with severe CP were randomized to receive omalizumab (n = 162) or placebo (n = 175) for 12 weeks. All patients received concomitant oral antihistamines and nasal corticosteroids as SoC.
Patients treated with omalizumab in addition to SoC (SoC + omalizumab) demonstrated statistically significant and clinically important improved lower nasal symptom score (combined score of sneezing, rhinorrhea, and nasal congestion; primary endpoint) compared with those receiving SoC + placebo. This improvement was supported by the results that patients treated with SoC + omalizumab had more nasal symptom-free days and fewer days with severe or most severe nasal symptoms. In addition, the ocular symptom score (combined score for itchy eye and watery eye) was also substantially improved with SoC + omalizumab. In agreement with these consistent results, SoC + omalizumab significantly improved all domains of quality-of-life scores, and reduced work productivity loss as well as activity impairment. No unexpected safety signals were observed, which demonstrated a favorable benefit-risk profile of omalizumab. Findings from this study indicate that omalizumab could be a new promising therapeutic option for severe CP/AR.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.