Omalizumab

(Xolair®)

Xolair®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 75 mg/0.5mL, 150 mg/mL)
Drug ClassAnti-IgE antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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
  • Indicated for 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
  • Indicated for chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment
  • Indicated for 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 oneor more foods
  • To be used in conunction with food allergen avoidance.

Latest News

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Summary
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  • This summary is based on the review of 42 systematic review(s)/meta-analysis(es). [1-41]
  • Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Omalizumab significantly improved nasal polyp score (NPS), nasal congestion score (NCS), and quality of life (sino-nasal outcome test (snot-22)), with long-term improvement maintenance. Dupilumab showed higher efficacy for NPS and quality of life than omalizumab and mepolizumab.
  • Chronic Urticaria (CU): Omalizumab effectively reduced weekly itch and hive scores and improved Urticaria Activity Score (UAS7) and Dermatology Life Quality Index (DLQI), with 300 mg showing greater efficacy than 150 mg. Ligelizumab at 72 mg and 240 mg outperformed omalizumab 300 mg in reducing urticaria symptoms.
  • Asthma: Omalizumab improved lung function (forced expiratory volume in 1 second (FEV₁)), reduced exacerbations, and decreased oral corticosteroid use with high certainty. Tezepelumab was more effective than omalizumab in reducing exacerbations and enhancing lung function.
  • Food Allergies: Omalizumab increased tolerated doses of multiple foods and supported higher maintenance doses when used alone or with oral immunotherapy.
  • Omalizumab did not significantly increase the incidence of adverse events (AEs) or serious adverse events (SAEs) compared to placebo across multiple conditions. No significant increase in drug-related SAEs was observed.
  • Increased risk of rheumatic adverse events, specifically arthralgia or joint pain, was observed in CRSwNP patients. Some injection site reactions and systemic allergic reactions were reported but were not statistically significant.
  • Similar safety profiles were noted among biologics; no significant difference in the incidence of AEs between ligelizumab and omalizumab. Dupilumab was associated with fewer nasopharyngitis cases compared to omalizumab, with a similar incidence of other AEs.
  • Children and adolescents with atopic dermatitis showed limited efficacy data for omalizumab, with improvements in SCORing Atopic Dermatitis (SCORAD) scores but lower effectiveness than dupilumab; no specific safety concerns were noted for this group. For severe asthma patients, omalizumab consistently improved lung function and reduced exacerbations without significant increases in serious adverse events. In food allergy patients, omalizumab was effective in increasing tolerated doses, especially in combination with oral immunotherapy, with mild to moderate adverse events. Elderly patients with chronic urticaria experienced symptom control and quality of life improvements, though polypharmacy and comorbidities should be carefully managed.

Product Monograph / Prescribing Information

Document TitleYearSource
Xolair (omalizumab) Prescribing Information.2024Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Rheumatic adverse events associated with biologic therapy for chronic rhinosinusitis: A systematic review and meta-analysis2024International Forum of Allergy & Rhinology
Cost and Cost-Effectiveness of the Management Strategies of Chronic Urticaria: A Systematic Review2024Jama Dermatology
A comprehensive analysis on the safety of two biologics dupilumab and omalizumab2024Frontiers in Medicine
Time-course and dose-effect of omalizumab in treating chronic idiopathic urticaria/chronic spontaneous urticaria2024European Journal of Clinical Pharmacology
Effectiveness and safety of systemic therapy for moderate-to-severe atopic dermatitis in children and adolescent patients: a systematic review2024Frontiers in Immunology
Comparative efficacy and safety of the treatment by Omalizumab for chronic idiopathic urticaria in the general population: A systematic review and network meta-analysis2024Skin Research and Technology : Official Journal of International Society for
Immunotherapy and biologics in the management of IgE-mediated food allergy: Systematic review and meta-analyses of efficacy and safety2024Allergy
Current options in the management of tree nut allergy: A systematic review and narrative synthesis2024Pediatric Allergy and Immunology : Official Publication of the European Society
Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis2024The World Allergy Organization Journal
Clinical Impacts of Omalizumab on the Psychiatric Comorbidities of Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis2024Journal of Drugs in Dermatology : Jdd
The effect of biologics in lung function and quality of life of patients with united airways disease: A systematic review2024The Journal of Allergy and Clinical Immunology. Global
Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review2023Journal of Investigational Allergology & Clinical Immunology
Effect of Biologic Therapies on Airway Hyperresponsiveness and Allergic Response: A Systematic Literature Review2023Journal of Asthma and Allergy
Safety and Tolerability of Omalizumab in Children with Allergic (IgE-Mediated) Asthma: A Systematic Review and Meta-Analysis2023Discovery Medicine
Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology. in Practice
Omalizumab in Allergic Bronchopulmonary Aspergillosis: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology. in Practice
Omalizumab in IgE-Mediated Food Allergy: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology. in Practice
Prevalence, Clinical Manifestations, Treatment, and Clinical Course of Chronic Urticaria in Elderly: A Systematic Review2022Journal of Asthma and Allergy
Systematic review of monotherapy with biologicals for children and adults with IgE-mediated food allergy2022Clinical and Translational Allergy
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison2022Journal of Medical Economics
Efficacy and Safety of Omalizumab for the Treatment of Severe or Poorly Controlled Allergic Diseases in Children: A Systematic Review and Meta-Analysis2022Frontiers in Pediatrics
Impact of Pharmacological Treatments for Chronic Spontaneous Urticaria with an Inadequate Response to H1-Antihistamines on Health-Related Quality of Life: A Systematic Review and Network Meta-Analysis2022The Journal of Allergy and Clinical Immunology. in Practice
Which Is the Best Biologic for Nasal Polyps: Dupilumab, Omalizumab, or Mepolizumab? A Network Meta-Analysis2022International Archives of Allergy and Immunology
Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: A systematic review and network meta-analysis2022The Journal of Allergy and Clinical Immunology
The Impact of Monoclonal Antibodies on Airway Smooth Muscle Contractility in Asthma: A Systematic Review2021Biomedicines
Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis2021The Cochrane Database of Systematic Reviews
Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials2021Bmj Open
Evaluation of Pharmacologic Treatments for H1 Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Network Meta-analysis2021Jama Dermatology
Biologics for chronic rhinosinusitis2021The Cochrane Database of Systematic Reviews
Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines2021Allergy
Systemic treatments in the management of atopic dermatitis: A systematic review and meta-analysis2021Allergy
Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines2021Allergy
Effect of monoclonal antibody drug therapy on mucosal biomarkers in airway disease: A systematic review2020Clinical and Experimental Allergy : Journal of the British Society for Allergy
Omalizumab for cholinergic urticaria: 6 months prospective study and systematic review of the literature2020Dermatologic Therapy
Symptomatic Dermographism: A Systematic Review of Treatment Options2020The Journal of Allergy and Clinical Immunology. in Practice
Efficacy and Safety of Omalizumab for Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2020American Journal of Therapeutics
Delayed Pressure Urticaria: A Systematic Review of Treatment Options2020The Journal of Allergy and Clinical Immunology. in Practice
Omalizumab in the treatment of adult patients with mastocytosis: A systematic review2020Clinical and Experimental Allergy : Journal of the British Society for Allergy
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma2020Allergy
The role of biologics in chronic rhinosinusitis: a systematic review2020International Forum of Allergy & Rhinology
Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous urticaria: Systematic review and meta-analysis2019Allergologia Et Immunopathologia

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