Study type

Study topic

Disease /health condition

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

Medical condition to be studied

Asthma
Population studied

Short description of the study population

Patients ≥18 years old who receive treatment according to GINA Step 5 or experience uncontrolled asthma at GINA Step 4 as per the definition of severe asthma.
Patients who were included in the International Severe Asthma Registry (ISAR) after they had started biologic treatment will not be included in the study unless pre-treatment data is available.

Inclusion criteria:
- Patients 18 years or older, who are receiving treatment according to GINA (2018 Criteria) step 5 or are uncontrolled at step 4. Uncontrolled asthma is defined as having severe asthma symptoms or frequent exacerbations requiring systemic corticosteroids.
- Patients prescribed with anti-IL5/5R, anti-IgE or anti-IL4/IL13 during study period
- Available registry data prior to or on biologic therapy initiation date
- Available registry data from biologic initiation date until a follow-up visit that is closest to a 1-year period (min. 16 weeks) or until date of switching/stopping their first biologic
- Switched/stopped their first biologic before first follow-up visit or before 16 weeks (as nonresponse)

Exclusion criteria:
- Patients who received bronchial thermoplasty
- Patients who are <18 years old
- Patients with a follow-up visit less than 16 weeks after biologic initiation date (without switch/stop)

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)

Special population of interest

Other

Special population of interest, other

Asthma patients

Estimated number of subjects

1609
Study design details

Main study objective

To classify responders to biologic treatment by clinical and functional endpoints and describe their characteristics overall and per biologic drug class.

Outcomes

To operationally assess response to biologic therapy by clinical and functional endpoints including exacerbations, systemic corticosteroids, asthma control and lung function. To describe and compare baseline (pre-therapy) demographic, clinical and functional characteristics of response and non-response groups to overall biologic treatment and by biologic class.

Data analysis plan

We are assessing improvement from at/before biologic initiation to after biologic therapy across 4 main domains of clinical response: Lung function, exacerbation, Long-term OCS, Asthma Control. What classifies as an improvement for each domain has been classified in agreement with published literature (e.g. clinical trials data). Level of response is also ascertained via assessing the number of domains with a positive change that a patient had. Finally, a responder is identified if they show improvement in more than 50% of the clinical response domains from the total of domain they have non-missing data for.