Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies
Study drug and medical condition

Name of medicine

FASENRA

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

BENRALIZUMAB

Anatomical Therapeutic Chemical (ATC) code

(R03DX10) benralizumab
benralizumab

Medical condition to be studied

Neoplasm malignant
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

14000
Study design details

Main study objective

To measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics.

Outcomes

Incidence of malignancy, Describing malignancy cases that occurred

Data analysis plan

This is a descriptive study with primary objective to estimate the incidence rate for malignancies in 3 cohorts of the overall severe asthma population: patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving any biologics.
Observed incidence rates will be presented together with nominal 95% exact confidence intervals (Clopper-Pearson). Difference in incidence rates between the cohorts will be presented with nominal 95% confidence intervals.