Tezepelumab-ekko

(Tezspire®)

Tezepelumab-ekko

Drug updated on 9/4/2024

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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  • Tezspire (tezepelumab-ekko) is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Tezepelumab significantly reduced annualized asthma exacerbations across multiple studies, with reductions ranging from 329 fewer exacerbations per 1000 patients (95% CI, 272.6-366.6) to an odds ratio (OR) of 0.67 (95% CI, 0.57-0.80) compared to placebo. It showed consistent effectiveness in patients with baseline blood eosinophil counts (BEC) of 0 to <150 cells/μL and a relative risk of 0.63 (95% CI, 0.46-0.86) versus benralizumab.
  • Lung function, as measured by forced expiratory volume in 1 second (FEV1), improved with tezepelumab treatment, showing mean differences (MD) of 0.24 L (95% CI, 0.16-0.32) and standard mean differences (SMD) of 0.28 (95% CI, 0.11-0.45) compared to placebo, with larger improvements observed compared to benralizumab and mepolizumab, although some confidence intervals crossed the null value.
  • Asthma control and quality of life metrics were positively impacted by tezepelumab, with a standard mean difference (SMD) in asthma control questionnaire score (ACQ-6) of -0.29 (95% CI, -0.39 to -0.20). However, improvements in quality of life varied with different doses, and some results were not statistically significant.
  • Tezepelumab was effective in reducing exacerbations and improving lung function in both eosinophilic and non-eosinophilic asthma populations, with consistent reduction in annualized asthma exacerbation rates (AAER) and improvements observed across varying eosinophil counts.
  • General Safety Concerns: Tezepelumab demonstrated a generally acceptable safety profile with no significant differences in adverse events (AEs) leading to discontinuation compared to placebo or other biologics. Non-serious AEs such as nasopharyngitis, headache, and bronchitis were noted, but there was no higher incidence of adverse drug reactions compared to placebo.
  • Serious Adverse Events (SAEs): A reduction in the incidence of serious adverse events (SAEs) was observed with tezepelumab treatment.
  • Comparison to Other Drugs: The incidence of AEs was similar across treatment groups, with no significant differences noted between tezepelumab and other biologics, including dupilumab, benralizumab, and mepolizumab.
  • There is no population types or subgroups information available in the reviewed studies.

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