Sustainability of response to biologics in severe asthma and predictors of late failure among patients in an international registry (SHINE)

Study type

• Study topic:
  Disease /health condition

  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

• Medicinal product name:
  CINQAERO

  DUPIXENT

  FASENRA

  NUCALA

  TEZSPIRE

  XOLAIR
• Medicinal product name, other:
  Cinqair
• Study drug International non-proprietary name (INN) or common name:
  BENRALIZUMAB

  DUPILUMAB

  MEPOLIZUMAB

  OMALIZUMAB

  TEZEPELUMAB
• Medical condition to be studied:
  Asthma
• Additional medical condition(s):
  Severe asthma

Population studied

• Short description of the study population:
  Patients diagnosed with severe asthma from 25 countries
• Age groups:
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)

Study design details

• Study design:
  Observational longitudinal study
• Main study objective:
  • To describe the frequencies of late failure and the type and extent of domain failure attributed to remission failures ; • To identify pre- and post-treatment characteristics associated with late failures ; • To describe persistence of late failures and the potential role of switching biologic agent in regaining remission after late failure;
• Setting:
  The study population will be extracted from the International Severe Asthma Registry database (data collected between 2017 and 2025). Eligibility criteria include having initiated biologic therapy, being adult at initiation, and having follow-up data for at least 2 years after initiation.
• Comparators:
  Patient demographic and clinical characteristics measured pre-initiation of biologic treatment and after 12 months of follow-up.
• Outcomes:
  The outcome of interest will be late failure, considered the first failure to meet three-domain remission definition (No exacerbations, no long-term oral corticosteroid use, partly or well-controlled asthma) recorded at a follow up occurring at least 24 months following biologic initiation. ;
• Data analysis plan:
  Outcome details: Remission status; Type: Yes, No; Model: Logistic regression; Estimates: Odds ratios
• Summary results:
  Not yet completed.