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
AstraZeneca
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.
Description
Tezepelumab (brand name: TEZSPIRE®), a human monoclonal antibody specific for the epithelial cell-derived cytokine thymic stromal lymphopoietin (TSLP), was recently launched as a first-in-class biologic add on treatment for patients with severe asthma. Results from DESTINATION, a long-term extension, phase 3 trial, showed a numeric imbalance in the occurrence of cardiac disorder system organ class serious adverse events (SAEs) in participants receiving tezepelumab compared to placebo. The observed imbalance resulted in the inclusion of serious cardiovascular events as an important potential ri…
Eligibility
- Age range
- 12–130 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period. Exclusion Criteria for both exposed and unexposed groups include: * \<12 months of data availability prior to index date, * age \<12 years at index date, * history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date…
Interventions
- DrugTezepelumab
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
- Danish registries (access/analysis)Copenhagen
- French National Health Data System (SNDS)Paris
- Team Gesundheit GKV Claims data (SHI)Berlin