Drug updated on 3/28/2024
| Dosage Form | Injection (subcutaneous; 210 mg/1.91 mL (110 mg/mL)) |
| Drug Class | Thymic stromal lymphopoietin blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Summary
- Tezepelumab-ekko (Tezspire) is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
- A total of 11 systematic reviews/meta-analyses were reviewed, providing information on the safety and effectiveness of Tezspire in comparison to other asthma biologics.
- The drug significantly improves pulmonary function tests, reduces annualized asthma exacerbation rates, lowers biomarkers related to T-helper 2 driven inflammation such as blood eosinophil count and fractional exhaled nitric oxide levels, thereby improving overall quality of life measures for patients with moderate-to-severe uncontrolled asthma.
- Compared to other biologics like dupilumab, benralizumab, mepolizumab, and reslizumab; tezepelumab demonstrates a competitive profile in reducing exacerbation rates while also showing improvement in forced expiratory volume within one second (FEV1).
- Safety profiles suggest that tezepelumab has an acceptable risk-benefit ratio due its lower incidence rate of serious adverse events compared to placebo; common side effects include nasopharyngitis, headache,and bronchitis.
- In terms of immunogenicity risks over time due to antidrug antibodies development which can diminish drug efficacy over time - it appears that tezeplumb may have a more favorable profile than benralizmub or other similar drugs used for treating severe asthama cases not adequately controlled by conventional therapies.
- Tezeplumb's broad range across patient subgroups suggests its versatility making it suitable for personalized medicine approaches when managing different phenotypes/endotypes associated with severe uncontrolled asthama.
- The pooled analysis from PATHWAY & NAVIGATOR trials indicates that irrespective allergy status or baseline inflammatory biomarker levels,tezeplumb significantly reduces exacerbation-related hospitalization or emergency department visits and improves secondary outcomes versus placebo.
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 |
|---|---|---|
| Asthma management in adults. | 2022 | The Journal of Allergy and Clinical Immunology: In Practice |