CROSSROADS-1: Treatment Outcomes among Tezspire Users: A Claims Data Study (20230159)

Study type

• Study topic:
  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

• Name of medicine:
  TEZSPIRE 210 MG - SOLUTION FOR INJECTION
• 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
• Additional medical condition(s):
  Asthma

Population studied

• Age groups:
  Adolescents (12 to < 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:
  300

Study design details

• Study design:
  Descriptive retrospective cohort study.
• Main study objective:
  Assess the reduction of asthma exacerbations resulting in hospitalizations, emergency visits, or outpatient visits and the reduction in exacerbation related health care resource use after initiation of Tezspire (post-index period) compared to the pre-index period.
• Setting:
  The index date will be between December 2021 (Tezspire [tezepelumab-ekko] launch) and the latest data available at the time of study execution (January 2024). The pre-index period will be the 12-months preceding the index date. The post-index period will be the 12-months following Tezspire (tezepelumab-ekko) initiation.
• Comparators:
  NA
• Outcomes:
  Reduction of Annualized asthma exacerbation rate.
• Data analysis plan:
  Categorical study variables will be reported as frequencies (counts and percentages). Continuous variables will be described by means, standard deviation (SD), median, and ranges. Asthma exacerbations will be reported as AAER (events per patient-year) assessed during the pre- and post-index, separately. One-sided paired t-tests will be used to test for differences in continuous outcomes observed between the pre- and post-index. McNemar-Bowker tests will be used to assess for pre-post differences in categorical variables.