Tezepelumab-ekko

(Tezspire®)

Tezepelumab-ekko

Drug updated on 12/11/2024

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 (TSLP) 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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  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Tezepelumab significantly reduced annualized asthma exacerbations, with an odds ratio (OR) of 0.67 (95% confidence interval (CI): [0.57, -0.80], P < .00001), and showed a relative risk (RR) of 0.63 (95% CI: [0.46, 0.86]) compared to placebo. Additionally, it consistently reduced airway hyperresponsiveness (AHR) in 3 studies.
  • Tezepelumab improved lung function, with a standardized mean difference (SMD) of 0.28 (95% CI: [0.11, 0.45], P = .001) for forced expiratory volume in 1 second (FEV₁), and a mean improvement in FEV₁ of 0.24 L (95% CI: [0.16, 0.32]) compared to placebo.
  • Tezepelumab demonstrated significant improvements in asthma control, as evidenced by reductions in asthma control questionnaire scores (Asthma Control Questionnaire (ACQ)-6 (standard mean difference (SMD) = -0.29, 95% CI = [-0.39, -0.20], P < .00001)) (SMD = -0.29, 95% CI: [-0.39, -0.20], P < .00001), and improved health-related quality of life for patients with asthma.
  • Biomarker reductions were observed with tezepelumab, including a decrease in fractional exhaled nitric oxide (FeNO) (mean difference (MD) = -10 ppb, 95% CI: [-15.81, -4.18], P = 0.0008) and blood eosinophil count (MD = -139.38 cells/mcL, 95% CI: [-150.37, -128.39], P < 0.00001).
  • Adverse Events: Tezepelumab was associated with common mild adverse events, such as nasopharyngitis, headache, and bronchitis. However, there was a significant reduction in serious adverse events compared to placebo, and patients treated with tezepelumab did not experience a higher incidence of adverse drug reactions compared to placebo.
  • Antidrug Antibodies (ADAs): The incidence of antidrug antibodies with tezepelumab was low at 1.12%, compared to higher rates observed with other biologics, such as benralizumab (8.35%). No significant neutralizing antibodies were reported, indicating a favorable immunogenicity profile for tezepelumab.
  • Comparison with Other Biologics: Tezepelumab demonstrated a better safety profile with fewer serious adverse events compared to other biologics like omalizumab, reslizumab, and mepolizumab, making it a favorable option in terms of safety for asthma management.
  • Tezepelumab demonstrated consistent efficacy in reducing asthma exacerbation rates across both T2-high and T2-low inflammation subgroups, with reductions in annualized asthma exacerbation rates observed across all baseline blood eosinophil count (BEC) categories, including patients with lower BEC (< 300 cells/µL), where other biologics showed reduced efficacy.

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
Biologic agents licensed for severe asthma: a systematic review and meta-analysis of randomised controlled trials2024European Respiratory Review
The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: A systematic review and meta-analysis of randomized controlled trials2023Medicine
Effect of Biologic Therapies on Airway Hyperresponsiveness and Allergic Response: A Systematic Literature Review2023Journal of Asthma and Allergy
Efficacy of Biologics in Severe, Uncontrolled Asthma Stratified by Blood Eosinophil Count: A Systematic Review2023Advances in Therapy
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
Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis2023The Journal of Allergy and Clinical Immunology
The Impact of Tezepelumab in Uncontrolled Severe Asthma: A Systematic Review of Randomized Controlled Trials2022Cureus
Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis2022Scientific Reports
Tezepelumab for Patients with Severe Uncontrolled Asthma: A Systematic Review and Meta-Analysis2022Journal of Asthma and Allergy
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison2022Journal of Medical Economics
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
The Impact of Monoclonal Antibodies on Airway Smooth Muscle Contractility in Asthma: A Systematic Review2021Biomedicines

Clinical Practice Guidelines

Document TitleYearSource
Risks and safety of biologics: A practical guide for allergists.2023The World Allergy Organization Journal