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Omalizumab

(Xolair®)

Omalizumab

Drug updated on 4/17/2024

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.

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Omalizumab (Xolair) is indicated for various allergic conditions, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and IgE-mediated food allergies. It has shown substantial improvements in symptoms across these conditions.
  • The information was derived from 47 studies focused on the application and outcomes of using Omalizumab.
  • In terms of population types and subgroup considerations, Omalizumab has been found significantly effective in children, adolescents, and adults with moderate-to-severe allergic asthma. Its use led to a reduction in the need for systemic corticosteroids and hospitalizations due to asthma exacerbations.
  • For CRSwNP patients, Omalizumab demonstrated effectiveness in reducing polyp size but showed poorer improvements in smell compared to Dupilumab.
  • In CSU patients, it improved urticaria activity scores with high rates of complete response while reducing the need for antihistamines; baseline total serum IgE levels can predict clinical response.
  • As an adjunct therapy or monotherapy option for managing IgE-mediated food allergies, particularly by reducing allergic reactions during accidental exposures; however, more long-term data is needed, especially when comparing its efficacy against other biologics like Benralizumab or Dupilumab.
  • Omalizumab's safety profile shows lower incidences of adverse drug reactions overall than other biologics used within this analysis, which included treatment-emergent antidrug antibodies (ADAs).
  • The longevity of response suggests sustained benefits well beyond the initial treatment year, up to four years, specifically observed within asthmatic patient populations, underlining its potential as a potent therapeutic option across approved indications despite varying degrees of relative efficacy depending on the condition being treated, such as stronger results seen in treating asthma versus CRSwNP where comparative analysis favored Dupilumab.

Product Monograph / Prescribing Information

Document TitleYearSource
Xolair (omalizumab) prescribing information.2024Genentech Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Biologic therapy in pediatric chronic rhinosinusitis: a systematic review.2024Otolarygology-Head and Neck Surgery
Chronic rhinosinusitis with nasal polyps (CRSwNP) treated with omalizumab, dupilumab, or mepolizumab: a systematic review of the current knowledge towards an attempt to compare agents' efficacy.2024International Forum of Allergy & Rhinology
Effects of omalizumab on lung function in patients with moderate-to-severe allergic asthma: a systematic review and meta-analysis.2024Therapeutic Advances in Respiratory Disease
Total IgE as a biomarker of omalizumab response in chronic spontaneous urticaria: a meta-analysis.2024Allergy and Asthma Proceedings
Association between serum total IgE levels and clinical response to omalizumab for chronic spontaneous urticaria: a systematic review and meta-analysis.2023The Journal of Allergy and Clinical Immunology: In Practice
Improvement in smell using monoclonal antibodies among patients with chronic rhinosinusitis with nasal polyps: a systematic review.2023Journal of Investigational Allergology & Clinical Immunology
Comparing four immunosuppressive agents for chronic spontaneous urticaria-a network meta-analysis.2023International Immunopharmacology
Biologicals in IgE-mediated food allergy.2023Current Opinion in Allergy and Clinical Immunology
Incidence of anti-drug antibodies to monoclonal antibodies in asthma: a systematic review and meta-analysis.2023Journal of Allergy and Clinical Immunology
Omalizumab in IgE-mediated food allergy: a systematic review and meta-analysis.2023Journal of Allergy and Clinical Immunology
Effectiveness and safety studies of omalizumab in children and adolescents with moderate-to-severe asthma.2023Journal of Pharmacy Practice
Effectiveness and safety studies of omalizumab in children and adolescents with moderate-to-severe asthma.2023Journal of Pharmacy Practice
Severe pediatric asthma therapy: omalizumab-a systematic review and meta-analysis of efficacy and safety profile.2023Frontiers in Pediatrics
Omalizumab for the treatment of bullous pemphigoid: a systematic review of efficacy and safety.2022Journal of Cutaneous Medicine and Surgery
Comparison between chronic spontaneous urticaria and chronic induced urticaria on the efficacy of omalizumab treatment: a systematic review and meta-analysis.2022Dermatologic Therapy
Omalizumab in allergic bronchopulmonary aspergillosis: a systematic review and meta-analysis.2022The Journal of Allergy and Clinical Immunology: In Practice
Adverse events of biological therapy in chronic rhinosinusitis with nasal polyps: a systematic review.2022American Journal of Otolarygology
Prevalence, clinical manifestations, treatment, and clinical course of chronic urticaria in elderly: a systematic review.2022Journal of Ashtma and Allergy
Systematic review of monotherapy with biologicals for children and adults with IgE-mediated food allergy.2022Clinical and Translational Allergy
Predictive biomarkers for response to omalizumab in patients with severe allergic asthma: a meta-analysis.2022Expert Review of Respiratory Medicine
Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: a systematic review and network meta-analysis.2022Journal of Allergy and Clinical Immunology
Effects of therapeutic antibodies on gene and protein signatures in asthma patients: a comparative systematic review.2022Biomedicines
Effectiveness and safety studies of omalizumab in children and adolescents with moderate-to-severe asthma.2021Journal of Pharmacy Practice
Use of omalizumab for management of idiopathic anaphylaxis: a systematic review and retrospective case series.2021Annals of Allergy, Asthma, & Immunology
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-analysis.2021Journal of Allergy and Clinical Immunology
Which is the best biologic for nasal polyps: dupilumab, omalizumab, or mepolizumab? A network meta-analysis.2021International Archives of Allergy and Immunology
Evaluation of pharmacologic treatments for H1 antihistamine-refractory chronic spontaneous urticaria: a systematic review and network meta-analysis.2021JAMA Dermatology
Efficacy and safety of omalizumab in children with moderate-to-severe asthma: a meta-analysis.2021Journal of Asthma
Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials.2021BMJ Open
Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: a systematic review for the EAACI guidelines.2021Allergy
Real-world effectiveness of omalizumab in severe allergic asthma: a meta-analysis of observational studies.2021Journal of Allergy and Clinical Immunology
'Real-world' effectiveness of omalizumab in adults with severe allergic asthma: a meta-analysis.2021Expert Review of Clinical Immunology
Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: a systematic review for the EAACI Biologicals Guidelines.2021Allergy
Biologics for chronic rhinosinusitis.2021Cochrane Database of Systematic Reviews
Omalizumab in the treatment of adult patients with mastocytosis: a systematic review.2020Clinical & Experimental Allergy
Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis.2020Current Medical Research and Opinion
Phototherapy may be a useful adjuvant therapy for retractable chronic spontaneous urticaria: a systematic review.2020Photochemistry and Photobiology
Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma.2020Allergy, Ashma and Clinical Immunology
Omalizumab retreatment in patients with chronic spontaneous urticaria: a systematic review of published evidence.2020European Annals of Allergy and Clinical Immunology
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: a systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.2020Allergy
The role of biologics in chronic rhinosinusitis: a systematic review.2020International Forum of Allergy & Rhinology
Biologics for chronic rhinosinusitis.2020Cochrane Database of Systematic Reviews
Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma.2020Annals of Allergy, Asthma & Immunology
Systematic reviews of pharmacological and nonpharmacological treatments for patients with chronic urticaria: an umbrella systematic review.2019Medicine
Therapeutic strategy according to differences in response to omalizumab in patients with chronic spontaneous urticaria.2019Journal of Investigational Allergology & Clinical Immunology
Omalizumab and long-term quality of life outcomes in patients with moderate-to-severe allergic asthma: a systematic review.2019Therapeutic Advances in Respiratory Disease
Benefits and harms of omalizumab treatment in adolescent and adult patients with chronic idiopathic (spontaneous) urticaria: a meta-analysis of “real-world” evidence.2019JAMA Dermatology
Effectiveness and safety of omalizumab in the treatment of chronic spontaneous urticaria: systematic review and meta-analysis.2019Allergologia et Immunopathologia
Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018.2019Expert Review of Clinical Immunology

Clinical Practice Guidelines

Document TitleYearSource
2022 GINA report, global strategy for asthma management and prevention.2022GINA
An updated therapeutic strategy for chronic idiopathic urticaria.2021Journal of Drugs in Dermatology
Taiwanese Dermatological Association consensus for the definition, classification, diagnosis, and management of urticaria: a 2021 update.2021Journal of the Formosan Medical Association
Severe asthma: adding new evidence - Latin American Thoracic Society.2021ERJ Open Research
Management of chronic urticaria in children: a clinical guideline.2020Italian Journal of Pediatrics
Management of chronic urticaria in children: a clinical guideline.2019Italian Journal of Pediatrics