Real-World Analysis of Exacerbations and Exacerbation-Related Costs Among Patients with Asthma Receiving Tezepelumab (CROSSROADS-5) (20240066)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort
• Non-interventional study design, other:
  Non-interventional retrospective database analysis.

Study drug and medical condition

• Name of medicine:
  TEZSPIRE 210 MG - SOLUTION FOR INJECTION
• Name of medicine, other:
  Tezepelumab
• Study drug International non-proprietary name (INN) or common name:
  TEZEPELUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX11) tezepelumab

  tezepelumab
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients with severe asthma with asthma exacerbations in the baseline period.
• Age groups:
  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1396

Study design details

• Study design:
  Descriptive retrospective cohort study
• Main study objective:
  To describe asthma exacerbations in the 12-months following initiation of tezepelumab (12-month post-index period) relative to the baseline period (12-month pre-index period) among patients with severe asthma
• Setting:
  The study population consists of asthma patients 12 years of age or older with ≥2 medical claims for tezepelumab during the identification period (December 17, 2021 to 12 months prior to latest available data at the time of data extraction) in the United States. ; Patients will be identified in the MORE2 Registry® database and the 100% Medicare Fee-for-Service (FFS) database.
• Comparators:
  NA
• Outcomes:
  Primary outcomes; • Annual asthma exacerbation rate (AAER) in the pre-index period.; • AAER in the post-index period.; • Percentage change in AAER between the pre- and post-index periods.; ; Secondary outcomes; • Number of tezepelumab claims.; • Time to tezepelumab discontinuation.; • Proportion of days covered (PDC).; • Adherence based on PDC categories (PDC≥0.80; PDC 0.50-0.80, PDC <0.50).; • Exacerbation-related healthcare resource utilization in the pre-index and post-index periods.; • Exacerbation-related costs in the pre-index and post-index periods.; • Ratio of exacerbation-related healthcare resource utilization between the pre-index and post-index periods.; • Ratio of exacerbation-related costs between the pre-index and post-index periods.; • Cumulative oral corticosteroids (OCS) dose in the pre- index and post-index periods.; • Cumulative OCS dose ratio between the pre-index and post-index periods.
• Data analysis plan:
  Categorical study variables will be reported as frequencies (counts and percentages). Continuous variables will be described by means, standard deviation (SD), and medians. Ratios will be reported as a percentage change between the pre-index and post-index periods. ; AAER ratios between the post-index period relative to the pre-index period will be estimated using a generalized estimating equation (GEE) model with a Poisson distribution and a log link function. ; The ratio between exacerbation-related healthcare resource utilization in the post-index period relative to the pre-index period will be estimated using a GEE model with a negative binomial distribution (as appropriate) and a log link. ; The ratio of exacerbation-related costs between the post-index period relative to the pre-index period will be estimated using a GEE model with a gamma distribution and a log link. ; These analyses will be descriptive in nature and no hypothesis testing will be conducted.