EffectIveness of bioloGics (by classes) in patieNts with dIfferent combination of T2 biomarkErs (IGNITE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Observational

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with severe asthma identified from the international severe asthma registry (ISAR) for the period of 2018 to 2021.; Inclusion Criteria:; Objective 1: All patients with sufficient biomarker information available to be included in any of the analyses.; Objective 2: All patients prescribed biologics and with relevant data available for biomarkers, biologics treatment, exacerbations, lung function and asthma control.; Objective 3: All patients prescribed biologics and with pre-biologic biomarker data for all three biomarkers, biologics treatment, and relevant outcomes information.; ; Exclusion Criteria:; Objectives 1, 2, and 3 :; • <18 years at the index date; • Patients treated with bronchial thermoplasty
• 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:
  Patients with severe asthma
• Estimated number of subjects:
  11000

Study design details

• Main study objective:
  To investigate whether T2 inflammatory biomarker measurements tend to be correlated within patients, and whether biomarker traits are associated with responsiveness to treatment with biologics
• Outcomes:
  Responsiveness to treatments with biologics, T2 biomarker measurements, Exacerbations, lung function, extent of asthma control
• Data analysis plan:
  Objective 1 will use linear and logistic regression to identify whether it appears to be the case that biomarker values tend to be associated within the same individual Objective 2 will use generalised estimating equations to assess whether exacerbation rates appear to change over time according to biomarker values Objective 3 will use backward stepwise models to assess whether including more biomarker information significantly improves model fit Data will be described and associations tested using t-tests, ANOVA, or chi-square depending on the format of the data