CLinical oUtcomes before and after biologic treatMent by bIologic class, by iNdividuAl biologic, and by subgroups of baseliNe characTeristics (LUMINANT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Registry-based longitudinal cohort study

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• 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)
• Estimated number of subjects:
  11000

Study design details

• Main study objective:
  To describe the ISAR cohort who initiate biologic treatment and examine clinical outcomes at 12 months by biologic class, and subgroups of patients, and compare these to those not initiated on biologic medications
• Outcomes:
  Asthma exacerbations, asthma control, oral corticosteroid use and dose, healthcare utilisation, lung function, Inflammatory markers, asthma symptoms, lung function
• Data analysis plan:
  Overall and by subset groups (type of biologics, individual biologics, and baseline characteristics), descriptive statistics for Section 5.1 Demographic Variables (Table 2) and Section 5.2 Clinical Variables (Table 3) will be provided for continuous and categorical variables accordingly: Descriptive statistics for the overall population and by subgroup of interest: •For variables measured on the interval or ratio scale, summary statistics produced will be: Sample size (n), Percentage nonmissing, Mean, Standard deviation, Range (minimum-maximum), Median •Inter-quantile range (25th and 75th percentile) •For categorical variable the summary statistics will include: Sample size (n) •Range (if applicable) •Count and percentage by category (distribution) •Characteristics of study groups will be compared and tested for statistical significance via McNemar’s tests for comparison of counts data, t-test, or one-way analysis of variance (ANOVA) for continuous variables.