Drug updated on 9/4/2024
Dosage Form | Injection (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 Class | Thymic 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
- 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 Title | Year | Source |
---|---|---|
Tezspire (tezepelumab-ekko) Prescribing Information. | 2023 | Amgen Inc., Thousand Oaks, CA and AstraZeneca AB, Sodertalje, Sweden |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Risks and safety of biologics: a practical guide for allergists. | 2023 | The World Allergy Organization Journal |
Asthma management in adults. | 2022 | The Journal of Allergy and Clinical Immunology: In Practice |