Tezepelumab-ekko

(Tezspire®)

Tezepelumab-ekko

Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 210 mg/1.91 mL [110 mg/mL] in a single-dose glass vial, 210 mg/1.91 mL [110 mg/mL] in a single-dose pre-filled syringe, 210 mg/1.91 mL [110 mg/mL] in a single-dose pre-filled pen)
Drug ClassThymic stromal lymphopoietin blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

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Summary
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  • Tezepelumab-ekko (Tezspire) is recommended for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma, showing significant efficacy in reducing the annualized asthma exacerbation rate (AAER) and improving lung function across various studies.
  • Twelve systematic reviews/meta-analyses were analyzed to evaluate Tezspire's safety and effectiveness in comparison to other biologics used in treating severe asthma.
  • Tezspire has proven effective regardless of baseline eosinophil count, making it a versatile treatment option for severe asthma in a wide range of patient subgroups. This inclusivity sets it apart from other biologics like benralizumab, dupilumab, or mepolizumab, which often show increased efficacy directly tied to higher eosinophil counts.
  • By targeting thymic stromal lymphopoietin (TSLP), an initial element in the inflammatory cascade, Tezspire may provide broader efficacy across Type 2-high and Type 2-low asthmas, unlike some biologics predominantly effective only against Type 2-high eosinophilic asthmas.
  • Comparative analyses indicate that Tezspire and dupilumab significantly reduce exacerbations in eosinophilic asthma, with indirect comparisons suggesting comparable or slightly superior effectiveness of Tezepelumab-ekko over other drugs.
  • The safety profile is favorable, as most studies report similar incidence rates of adverse events among those treated with Tezepelumab-ekko versus placebo groups; common side effects include nasopharyngitis, headache, and bronchitis, which are consistent with or slightly better than profiles seen among users of different types of biological treatments for asthma.
  • Serious adverse events were not significantly higher among patients treated with Tezepelumab-ekko compared to placebo, aligning well with findings related to other biologics like dupilumab, benralizumab, and mepolizumab.
  • Tezspire has demonstrated consistent benefits across a diverse array of patient subgroups, including different levels of eosinophils and allergic status, making it potentially more universally applicable for severe asthma treatment. This contrasts with some biologics whose efficacy may diminish or become conditional upon certain inflammatory profiles or eosinophil thresholds.

Product Monograph / Prescribing Information

Document TitleYearSource
Tezspire (tezepelumab-ekko) Prescribing Information.2023Amgen Inc., Thousand Oaks, CA and AstraZeneca AB, Sodertalje, Sweden

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A comparison of the effectiveness of biologic therapies for asthma a systematic review and network meta-analysis.2023Annals of Allergy, Asthma & Immunology
The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: a systematic review and meta-analysis of randomized controlled trials.2023Medicine
Efficacy of tezepelumab in severe, uncontrolled asthma: pooled analysis of the PATHWAY and NAVIGATOR clinical trials.2023American Journal of Respiratory and Critical Care Medicine
Efficacy of biologics in severe, uncontrolled asthma stratified by blood eosinophil count: a systematic review.2023Advances in Therapy
Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: a Bayesian network meta-analysis. 2023The Journal of Allergy and Clinical Immunology
Tezepelumab for patients with severe uncontrolled asthma: a systematic review and meta-analysis.2022Journal of Asthma and Allergy
Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis. 2022Scientific Reports
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-analysis.2022Cells
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison.2022Journal of Medical Economics
The impact of tezepelumab in uncontrolled severe asthma: a systematic review of randomized controlled trials.2022Cureus
The impact of monoclonal antibodies on airway smooth muscle contractility in asthma: a systematic review.2021Biomedicines
Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis.2019Respiratory Research

Clinical Practice Guidelines

Document TitleYearSource
Risks and safety of biologics: a practical guide for allergists.2023The World Allergy Organization Journal
Asthma management in adults.2022The Journal of Allergy and Clinical Immunology: In Practice