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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OMALIZUMAB

  MEPOLIZUMAB

  RESLIZUMAB

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

  omalizumab

  (R03DX09) mepolizumab

  mepolizumab

  (R03DX08) reslizumab

  reslizumab

  (R03DX10) benralizumab

  benralizumab
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Eligible subjects are adults (≥18 years old) with severe asthma, defined as patients with uncontrolled asthma at GINA 2018 Step 4 or undergoing GINA 2018 Step 5 treatment at baseline, who have initiated a biologic after enrolment in ISAR, with at least 2 visits recorded, including a visit pre or at biologic initiation and 1 follow up visit post biologic treatment initiation (visit ≥24 weeks and closest to 1 year to be selected) in addition to ISAR registry inclusion criteria (Table 1).
• 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

• Study design:
  Registry-based longitudinal cohort study using a prospective international cohort
• 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.