Summary

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• Xolair (omalizumab) is indicated for moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids; chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment; chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment; IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods, to be used in conjunction with food allergen avoidance.
• This summary is based on the review of 47 systematic review(s)/meta-analysis(es). ^[1-47]
• Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Omalizumab significantly reduced polyp size, sinus opacification, symptom severity, and the need for surgery or systemic corticosteroids, though dupilumab provided greater benefits in primary and secondary outcomes.
• Asthma: Omalizumab improved lung function, notably in Forced Expiratory Volume in 1 second (FEV1) and the percentage of predicted normal FEV1 in patients with moderate-to-severe allergic asthma. In pediatric populations, it decreased asthma exacerbations, improved asthma control test scores, and lowered serum IgE levels.
• Chronic Spontaneous Urticaria (CSU): Omalizumab significantly improved urticaria activity and itch severity scores, with a higher response in patients with elevated serum IgE levels. It was more effective than placebo in improving these outcomes and quality of life.
• Food Allergy: Omalizumab, as monotherapy or combined with oral immunotherapy, significantly increased tolerated food doses, improved quality of life, and reduced the severity of allergic reactions.
• Common adverse events associated with omalizumab include headaches, injection site reactions, and nasopharyngitis across different studies and patient populations.
• No significant difference in the risk of serious adverse events was noted for omalizumab compared to placebo in most studies, with a low incidence of serious adverse events specifically observed in patients with chronic spontaneous urticaria (CSU).
• The incidence of anti-drug antibodies (ADAs) was lowest with omalizumab compared to other biologics, such as benralizumab, which exhibited a higher ADA incidence, potentially influencing its safety profile.
• Omalizumab demonstrated effectiveness and safety across various subgroups, including pediatric patients with asthma and CRSwNP, patients with high IgE levels in CSU, and individuals with IgE-mediated food allergies, improving exacerbation rates, lung function, food tolerance thresholds, and quality of life, with consistent effectiveness observed regardless of baseline IgE levels.