Associations between biological and clinical response following treatment with anti-IL5/5R biologics (FLAME)

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:
  FASENRA

  NUCALA
• Name of medicine, other:
  Anti-IL5/5R biologic treatments for asthma, Cinquair
• Study drug International non-proprietary name (INN) or common name:
  BENRALIZUMAB

  MEPOLIZUMAB

  RESLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX10) benralizumab

  benralizumab

  (R03DX09) mepolizumab

  mepolizumab

  (R03DX08) reslizumab

  reslizumab

Population studied

• Short description of the study population:
  The study will use data from severe asthma patients enrolled in the International Severe Asthma Registry (ISAR) who initiated an anti-IL5/5R biologic treatment.
• Age groups:
  • Adult and elderly population (≥18 years)

    • 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:
  People living with severe asthma
• Estimated number of subjects:
  3000

Study design details

• Study design:
  Historical cohort study using data from the International Severe Asthma Registry (ISAR)
• Main study objective:
  To identify and describe patient characteristics associated with biological and/or clinical treatment failure at different times after initiation of anti-IL5/5R biologics and the extent to which these are linked or independent events.
• Setting:
  Adult patients enrolled in the ISAR who initiated treatment with an anti-IL5/5R biologic.
• Comparators:
  N/A
• Outcomes:
  Changes in blood eosinophil count (BEC) over time ; ; Changes in lung function (forced expiratory volume (FEV1)) over time ; ; Changes in exacerbation rate over time
• Data analysis plan:
  Test for associations between changes in BEC and changes in FEV1 and exacerbations (compared to their baseline values) one year after biologic initiation, and identify factors that modify these associations or explain the remaining variability. ; ; Describe the different patterns of change over time in BEC, FEV1 and exacerbations following initiation of anti-IL5/5R treatments. ; ; Test for associations between baseline patient characteristics and different patterns of change over time in BEC and/or FEV1 and exacerbations following initiation of anti-IL5/5R, taking into account the modifying factors identified in the first year (see (i) above).
• Summary results:
  The study will reveal whether biological and/or clinical failure of anti-IL5/5R treatments in the short or long term can be predicted from patient characteristics known pre-biologic initiation, or whether subsequent failure can be predicted from early follow-up data. ; This information will help clinicians in selecting the best treatment for patients and provide important evidence on the information that should be collected before and after biologic initiation. ; Results will be published in international peer reviewed journals and at an international respiratory conference.