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:
  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, other:
  TEZSPIRE
• Study drug International non-proprietary name (INN) or common name:
  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 treatment patterns of new users of Tezspire at 6 and 12 months after treatment initiation (post-index period); - Assess reduction of asthma exacerbations resulting in hospitalizations, emergency visits, or outpatient vis
• 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 (anticipated 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.
• 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 measures of adherence, persistence, and discontinuation of Tezspire (tezepelumab-ekko) use in the follow-up period. Additionally, switches to other treatments will be captured in the follow-up period.; Outcomes for Primary Objective 3 include reduction of Annualized Asthma Exacerbation Rate (AAER).
• 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.; ; For Objective 3 and Exploratory Objectives, analyses will be descriptive. 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. Additionally, reduction in Annualized Asthma Exacerbation Rate (AAER) between pre- and post- Tezspire (tezepelumab-ekko) initiation time periods will be compared using Generalized estimating equations.