Dupilumab

(Dupixent®)

Dupixent®

Drug updated on 10/30/2024

Dosage FormPre-Filled Syringe Injection (subcutaneous; 100 mg/ 0.67 mL, 200 mg/1.14 mL, 300 mg/2 mL); Pre-Filled Pen Injection (subcutaneous; 200 mg/ 1.14 mL, 300 mg/ 2 mL)
Drug ClassInterleukin-4 receptor alpha antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
  • DUPIXENT can be used with or without topical corticosteroids
  • Indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma
  • Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus
  • Indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)
  • Indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE)
  • Indicated for the treatment of adult patients with prurigo nodularis (PN).

Latest News

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Summary
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  • This summary is based on the review of 68 systematic review(s)/meta-analysis(es). [1-68]
  • Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Dupilumab demonstrated the highest efficacy in improving the nasal polyp score (NPS), Sino-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), and nasal congestion score (NCS), outperforming omalizumab and mepolizumab.
  • Eosinophilic Otitis Media: Biologic treatments, including dupilumab, significantly improved otitis media-related subjective scores and reduced serum eosinophil and IgE levels. Hearing thresholds remained unchanged, and no significant differences were observed between dupilumab and other biologics.
  • Atopic Dermatitis (AD): Dupilumab significantly reduced the Eczema Area and Severity Index (EASI) score and improved quality of life across age groups. EASI-75 achievement rates varied between age cohorts. Dupilumab was more effective than systemic immunosuppressants like methotrexate and cyclosporine and comparable to other biologics.
  • Asthma: Dupilumab significantly reduced severe asthma exacerbations and improved lung function (FEV1). Its effectiveness was comparable to tezepelumab in these measures.
  • Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Dupilumab was associated with an increased risk of injection-site reactions but a lower risk of asthma worsening compared to other biologics. Dupilumab posed a higher risk of injection-site reactions than placebo and other biologics such as lebrikizumab and benralizumab.
  • Atopic Dermatitis (AD): Common adverse events with dupilumab included conjunctivitis and nasopharyngitis. Dupilumab demonstrated a favorable safety profile compared to systemic immunosuppressants, with similar rates of severe adverse events as other biologics like tralokinumab and abrocitinib. Pediatric safety profiles were consistent with those observed in adults.
  • Asthma: Dupilumab was linked to increased blood eosinophils, but no significant differences in other adverse events were observed compared to placebo. Its safety profile was comparable to other biologics such as tezepelumab and benralizumab.
  • Studies on chronic rhinosinusitis with nasal polyps (CRSwNP) included primarily adult patients, often with comorbid asthma, with no specific subgroup differences in effectiveness or safety reported beyond the general population findings.
  • For atopic dermatitis (AD), studies covered a range of age groups, from infants to adults. Pediatric and adolescent patients had varying rates of EASI-75 achievement, though safety profiles were consistent across age groups.

Product Monograph / Prescribing Information

Document TitleYearSource
Dupixent (dupilumab) Prescribing Information.2024Regeneron Pharmaceuticals, Inc., Tarrytown, NY

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
Efficacy of Biologic Therapies for Eosinophilic Otitis Media: A Systematic Review and Meta-analysis2024The Journal of International Advanced Otology
Systematic review and network meta-analysis of the risk of malignancy with biologic therapies and selective Janus kinase-1 inhibitors in atopic dermatitis2024Postepy Dermatologii i Alergologii
Comparative safety of monoclonal antibodies in chronic inflammatory airway diseases (chronic sinusitis with nasal polyposis and asthma): A network meta-analysis2024International Immunopharmacology
A systematic review and expert Delphi Consensus recommendation on the use of vaccines in patients receiving dupilumab: A position paper of the American College of Allergy, Asthma and Immunology2024Annals of Allergy, Asthma & Immunology
Effectiveness and safety of systemic therapy for moderate-to-severe atopic dermatitis in children and adolescent patients: a systematic review2024Frontiers in Immunology
Systematic review and network meta-analysis of the risk of Herpes zoster with biological therapies and selective Janus kinase-1 inhibitors in atopic dermatitis2024Postepy Dermatologii i Alergologii
Janus kinase inhibitors in atopic dermatitis: an umbrella review of meta-analyses2024Frontiers in Immunology
Network meta-analysis of the efficacy and safety of monoclonal antibodies and traditional conventional dichotomous agents for chronic obstructive pulmonary disease2024Frontiers in Medicine
Abrocitinib, tralokinumab and upadacitinib for treating moderate-to-severe atopic dermatitis2024Health Technology Assessment (Winchester, England)
Efficacy of dupilumab plus topical corticosteroids in children with atopic dermatitis: A meta-analysis of randomized controlled trials2024Immunity, Inflammation and Disease
Effectiveness of systemic treatments on pruritus associated with atopic dermatitis: A systematic review in pediatric patients2024Pediatric Dermatology
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
Comparing binary efficacy outcomes for systemic immunomodulatory treatments for atopic dermatitis in a living systematic review and network meta-analysis2024The British Journal of Dermatology
Integrative Approaches to Sleep Management in Skin Disease: Systematic Review2023JMIR Dermatology
Short-term efficacy and safety of biologics and Janus kinase inhibitors for patients with atopic dermatitis: A systematic review and meta-analysis2023Heliyon
Association of risk of incident acne and treatment with systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and meta-analysis2023Inflammation Research
Systemic treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials2023The Journal of Allergy and Clinical Immunology
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
Cost-Effectiveness of Emerging Treatments for Atopic Dermatitis: A Systematic Review2023PharmacoEconomics
Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis2023Heliyon
Efficacy of Biologics in Severe, Uncontrolled Asthma Stratified by Blood Eosinophil Count: A Systematic Review2023Advances in Therapy
Dupilumab in Inflammatory Skin Diseases: A Systematic Review2023Biomolecules
Association between Dupilumab and Conjunctivitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2023Pharmaceutics
Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology
A comparison of the effectiveness of biologic therapies for asthma: A systematic review and network meta-analysis2023Annals of Allergy, Asthma & Immunology
Attenuating the atopic march: Meta-analysis of the dupilumab atopic dermatitis database for incident allergic events2023The Journal of Allergy and Clinical Immunology
Efficacy of topical and systemic treatments for atopic dermatitis on pruritus: A systematic literature review and meta-analysis2022Frontiers in Medicine
Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis2022The Australasian Journal of Dermatology
Dupilumab-associated ocular surface disease: An interdisciplinary decision framework for prescribers in the Australian setting2022The Australasian Journal of Dermatology
Association of Risk of Incident Venous Thromboembolism With Atopic Dermatitis and Treatment With Janus Kinase Inhibitors: A Systematic Review and Meta-analysis2022JAMA Dermatology
Comparative Efficacy and Safety of Monoclonal Antibodies and Janus Kinase Inhibitors in Moderate-to-severe Atopic Dermatitis: A Systematic Review and Meta-analysis2022Acta Dermato-Venereologica
Efficacy and Safety of Multiple Dupilumab Dose Regimens in Patients with Moderate-To-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2022Dermatology (Basel, Switzerland)
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison2022Journal of Medical Economics
Systemic Immunomodulatory Treatments for Atopic Dermatitis: Update of a Living Systematic Review and Network Meta-analysis2022JAMA Dermatology
Comparative Efficacy and Safety of Tezepelumab and Other Biologics in Patients with Inadequately Controlled Asthma According to Thresholds of Type 2 Inflammatory Biomarkers: A Systematic Review and Network Meta-Analysis2022Cells
Infections in children and adolescents treated with dupilumab in pediatric clinical trials for atopic dermatitis-A pooled analysis of trial data2022Pediatric Dermatology
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
Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response2022The Journal of Dermatological Treatment
Anti-interleukin-13 and anti-interleukin-4 agents versus placebo, anti-interleukin-5 or anti-immunoglobulin-E agents, for people with asthma2021The Cochrane Database of Systematic Reviews
The Impact of Monoclonal Antibodies on Airway Smooth Muscle Contractility in Asthma: A Systematic Review2021Biomedicines
Comparing quality of life outcomes of JAK inhibitors and biological treatments for atopic dermatitis: a systematic review and network meta-analysis2021Expert Review of Clinical Pharmacology
Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma2021CPT: Pharmacometrics & Systems Pharmacology
Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis2021Journal of the European Academy of Dermatology and Venereology
Biological Therapies for Atopic Dermatitis: A Systematic Review2021Dermatology (Basel, Switzerland)
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
Facial and neck erythema associated with dupilumab treatment: A systematic review2021Journal of the American Academy of Dermatology
Systemic treatments in the management of atopic dermatitis: A systematic review and meta-analysis2021Allergy
Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis2021Journal of the American Academy of Dermatology
New treatments in atopic dermatitis2021Annals of Allergy, Asthma & Immunology
Efficacy and safety of dupilumab for moderate-to-severe atopic dermatitis: A systematic review for the EAACI biologicals guidelines2021Allergy
Dupilumab use in dermatologic conditions beyond atopic dermatitis - a systematic review2021The Journal of Dermatological Treatment
Systemic treatments for eczema: a network meta-analysis2020The Cochrane Database of Systematic Reviews
Effect of monoclonal antibody drug therapy on mucosal biomarkers in airway disease: A systematic review2020Clinical and Experimental Allergy
What's new in atopic eczema? An analysis of systematic reviews published in 2018. Part 2: systemic therapies2020Clinical and Experimental Dermatology
Systemic Immunomodulatory Treatments for Patients With Atopic Dermatitis: A Systematic Review and Network Meta-analysis2020JAMA Dermatology
Efficacy and safety of treatment with dupilumab for severe asthma: A systematic review of the EAACI guidelines-Recommendations on the use of biologicals in severe asthma2020Allergy
Biologics for chronic rhinosinusitis2020The Cochrane Database of Systematic Reviews
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
Comparative Efficacy and Safety of Dupilumab and Benralizumab in Patients with Inadequately Controlled Asthma: A Systematic Review2020International Journal of Molecular Sciences
Matching-adjusted comparison of oral corticosteroid reduction in asthma: Systematic review of biologics2020Clinical and Experimental Allergy
Effect of Anti-IL5, Anti-IL5R, Anti-IL13 Therapy on Asthma Exacerbations: A Network Meta-analysis2020Lung
The role of biologics in chronic rhinosinusitis: a systematic review2020International Forum of Allergy & Rhinology
Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS)2020The British Journal of Dermatology
Use of dupilumab on the treatment of moderate-to-severe asthma: a systematic review2019Revista da Associacao Medica Brasileira

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