Drug updated on 10/25/2024
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 (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.
Latest News
Summary
- 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% 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 (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 = -10 ppb, 95% CI: [-15.81, -4.18], P = 0.0008) and blood eosinophil count (mean difference = -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 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 |