Assessing the impact of earlier access to biologics on remission and natural course of asthma (GLEAM)

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:
  DUPIXENT

  FASENRA

  NUCALA

  TEZSPIRE 210 MG - SOLUTION FOR INJECTION

  XOLAIR
• Name of medicine, other:
  Cinqair
• Study drug International non-proprietary name (INN) or common name:
  BENRALIZUMAB

  DUPILUMAB

  MEPOLIZUMAB

  OMALIZUMAB

  RESLIZUMAB

  TEZEPELUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX05) omalizumab

  omalizumab

  (R03DX08) reslizumab

  reslizumab

  (R03DX09) mepolizumab

  mepolizumab

  (R03DX10) benralizumab

  benralizumab

  (R03DX11) tezepelumab

  tezepelumab

  (D11AH05) dupilumab

  dupilumab
• Additional medical condition(s):
  Severe asthma

Population studied

• Short description of the study population:
  Patients diagnosed with severe asthma from 26 countries.
• Age groups:
  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with severe asthma
• Estimated number of subjects:
  15000

Study design details

• Study design:
  Observational study, historical cohort study
• Main study objective:
  Objective 1: ; To describe the timing of biologic therapy initiation using various proxies of time to initiation ; ; Objective 2: ; To assess whether the timing of biologic therapy initiation is associated with the course of the disease in patients with severe asthma, including remission, biomarkers and individual clinical outcomes.
• Setting:
  Data collected at a clinical setting from years 2017-2024
• Comparators:
  Early vs late biologic initiators
• Outcomes:
  Asthma clinical remission, exacerbation, Long-term OCS, asthma control, blood eosinophil count, Fractional exhaled nitric oxide
• Data analysis plan:
  Remission:; - Type: Yes / No, Univariable: Logistic regression ; ; Clinical outcomes:; - Exacerbations, Type: count, Univariable: Negative binomial ; - Total OCS, Type: Continuous, Univariable: Linear regression ; - Asthma control, Type: Ordinal, Univariable: Ordinal logistic regression ; - Lung function, Type: Continuous, Univariable: Linear regression ; ; Biomarkers:; - FeNO, Type: Continuous, Univariable: Median change from baseline to 3 months, 12 month, 2 yrs, 3 yrs (Linear or quantile regression) ; - BEC, Type: Continuous, Univariable: Median change from baseline to 3 months, 12 month, 2 yrs, 3 yrs (Linear or quantile regression) ; ; ;
• Summary results:
  Not yet completed.