CROSSROADS-2: Clinical Characteristics, Treatment Patterns, and Treatment Outcomes Among Users of Tezspire: An Electronic Medical Record (EMR) study (20220066)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  population description
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  TEZSPIRE
• 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)
  • Adults (18 to < 65 years)

    • 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:
  583

Study design details

• Study design:
  Descriptive retrospective cohort study
• Main study objective:
  - Describe the clinical characteristics of new users of Tezspire.; - Describe the proportion of patients in the cohort that are biologic-naïve or biologic experienced at Tezspire initiation, and the proportion of patients in the cohort by blood eosinophil count categories at Tezspire initiation, by quarter.
• Setting:
  In the TriNetX Dataworks-USA database, patients who newly initiated Tezspire (tezepelumab-ekko) at the age of 12 or older in the United States will be identified. The first Tezspire (tezepelumab-ekko) initiation date for the patient will be defined as the index date for all objectives.; ; The index date will be between December 2021 (Tezspire [tezepelumab-ekko] launch) and the latest data available at the time of study execution. 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.
• Outcomes:
  Outcomes for Primary Objective 1 will be baseline characteristics and include demographics, comorbidities, clinical asthma characteristics, and asthma-related medications, in the pre-index period. ; ; Outcomes for Primary Objective 2 include the proportion of patients in the cohort who are biologic-naïve or biologic-experienced, by quarter since Q4 2021 and the proportion of patients in the cohort, by quarter since Q4 2021, with blood EOS lab counts in the pre-index period (EOS lab categories will include <150 cells/µL, 150 - <300 cells/µL, ≥300 cells/µL)
• Data analysis plan:
  For Objectives 1 and 2, all analyses will be descriptive, without hypothesis or statistical testing. Continuous measures will be reported as mean, SD (Standard Deviation), median, IQR (Interquartile Range) (Q1, Q3) and range (min, max); categorical measures will be reported as count and percent.