Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

TEZSPIRE 210 MG - SOLUTION FOR INJECTION

Study drug International non-proprietary name (INN) or common name

TEZEPELUMAB

Anatomical Therapeutic Chemical (ATC) code

(R03DX11) tezepelumab
tezepelumab

Medical condition to be studied

Asthma

Additional medical condition(s)

Asthma
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

300
Study design details

Study design

Descriptive retrospective cohort study.

Main study objective

Assess the reduction of asthma exacerbations resulting in hospitalizations, emergency visits, or outpatient visits and the reduction in exacerbation related health care resource use after initiation of Tezspire (post-index period) compared to the pre-index period.

Setting

The index date will be between December 2021 (Tezspire [tezepelumab-ekko] launch) and the latest data available at the time of study execution (January 2024). The pre-index period will be the 12-months preceding the index date. The post-index period will be the 12-months following Tezspire (tezepelumab-ekko) initiation.

Comparators

NA

Outcomes

Reduction of Annualized asthma exacerbation rate.

Data analysis plan

Categorical study variables will be reported as frequencies (counts and percentages). Continuous variables will be described by means, standard deviation (SD), median, and ranges. Asthma exacerbations will be reported as AAER (events per patient-year) assessed during the pre- and post-index, separately. One-sided paired t-tests will be used to test for differences in continuous outcomes observed between the pre- and post-index. McNemar-Bowker tests will be used to assess for pre-post differences in categorical variables.