Heart-event monitoring for people with severe asthma taking Tezepelumab (Tezspire)
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
This project will test whether taking tezepelumab (Tezspire) changes the risk of serious heart problems in adolescents and adults with severe asthma compared with high-intensity standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16640 (estimated) |
| Ages | 12 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | tezepelumab |
| Locations | 4 sites (Wilmington, Delaware and 3 other locations) |
| Trial ID | NCT06951867 on ClinicalTrials.gov |
What this trial studies
This is a non-interventional, longitudinal, population-based cohort analysis using secondary data from multiple national and commercial data sources in Denmark, France, Germany, and the USA. The study will describe rates of major adverse cardiovascular events (MACE: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in patients exposed and unexposed to tezepelumab and will use a prevalent new-user design for comparative analyses. Comparative analyses will apply propensity score matching and matching on treatment type and duration, and will exclude patients with recent outcome events or recent exposure to other biologics as specified. The primary aim is to quantify and compare long-term risks of serious cardiovascular events to meet post-authorization safety requirements.
Who should consider this trial
Good fit: Adolescents and adults (age ≥12) with severe asthma who received tezepelumab or high-intensity standard-of-care treatment during the inclusion period and who have at least 12 months of prior data and no history of congenital heart disease or heart transplant are eligible.
Not a fit: People under age 12, those with less than 12 months of available prior data, those with recent non-fatal myocardial infarction or stroke in the 180 days before the index date, or those currently on non-tezepelumab biologics within the specified clearance period are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could clarify long-term cardiovascular safety of tezepelumab and inform safer prescribing and regulatory decisions for people with severe asthma.
How similar studies have performed: Randomized trials such as DESTINATION identified a numeric imbalance in cardiac events that prompted this safety review, and while post-marketing population-based safety studies are standard for biologics, large multinational observational safety data for tezepelumab are still novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic * matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \[PS\] matching) will be applied to ensure exposed and unexposed patients' comparability
Where this trial is running
Wilmington, Delaware and 3 other locations
- Healthcare Integrated Research Database (HIRD) — Wilmington, Delaware, United States (Recruiting)
- Danish registries (access/analysis) — Copenhagen, Denmark (Recruiting)
- French National Health Data System (SNDS) — Paris, France (Recruiting)
- Team Gesundheit GKV Claims data (SHI) — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Egger — IQVIA Pty Ltd
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.