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Summary
The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.
Official title: An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab
Key Details
Gender
All
Age Range
12 Years - 130 Years
Study Type
OBSERVATIONAL
Enrollment
16640
Start Date
2025-09-15
Completion Date
2029-05-31
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Tezepelumab
The exposure of primary interest is tezepelumab for severe asthma. Exposure will be assessed based on prescriptions or administrations depending on the data source. A comparable cohort of unexposed patients treated with high-intensity SOC will be identified based on the presence of a trigger exposure (i.e., augmentation or change of the non-biologic high-intensity treatment that does not represent treatment de-escalation) to mirror tezepelumab start in the exposed cohort. Due to the limited knowledge of the cardiovascular profile of biologics, SOC for comparative analyses will only include non-biologic high-intensity treatment.
Locations (4)
Healthcare Integrated Research Database (HIRD)
Wilmington, Delaware, United States
Danish registries (access/analysis)
Copenhagen, Denmark
French National Health Data System (SNDS)
Paris, France
Team Gesundheit GKV Claims data (SHI)
Berlin, Germany