Assessing the impact of remission at 12-months post-initiation of biologic therapy on long-term clinical outcomes of patients with severe asthma (SPOTLIGHT)

Study type

• Study topic:
  Disease /health condition

  Herbal medicinal product
• 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:
  Cohort

Study drug and medical condition

• Name of medicine:
  CINQAERO

  DUPIXENT

  FASENRA

  NUCALA

  TEZSPIRE

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

  DUPILUMAB

  MEPOLIZUMAB

  OMALIZUMAB

  RESLIZUMAB

  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 26 countries.
• Age groups:
  • Adult and elderly population (≥18 years)

    • 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:
  Objective 1: To describe the patterns of remission over time and the patient characteristics of various patterns of remission.; Objective 2: To investigate the effect of remission on long-term clinical outcomes of asthma between those that graduate to remission at 12-months post-initiation of biologic therapy compared to those that do not.; ;
• 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:
  Patients who met remission criteria in the first year of follow-up versus those who did not.
• Outcomes:
  Asthma clinical remission, exacerbations, long-term OCS use, asthma symptom control, lung function.
• Data analysis plan:
  Outcome details:; Remission status; - Type: Yes, No; - Model: Logistic regression; - Estimates: Odds ratios; ; Exacerbations; - Type: Count; - Model: Negative binomial; - Estimates: Rate ratios; ; Long-term OCS use; - Type: Yes, No; - Model: Logistic regression; - Estimates: Odds ratios; ; Asthma control; - Type: Uncontrolled: yes/no; - Model: Logistic regression; - Estimates: Odds ratios; ; Lung function; - Type: Continuous; - Model: Linear regression; - Estimates: Mean differences
• Summary results:
  Not yet completed