Observational Cohort Study of Safety of Etrasimod During Pregnancy in US Claims Databases (C5041042)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  VELSIPITY
• Study drug International non-proprietary name (INN) or common name:
  ETRASIMOD
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AE05) etrasimod

  etrasimod

Population studied

• Short description of the study population:
  The study population will consist of pregnant individuals with UC and an estimated date of conception between 5 January 2023 and 30 September 2028 (with outcomes observed through 30 September 2029) who were exposed to etrasimod or other advanced UC treatments during pregnancy.
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  This is an observational cohort study that will be conducted within two US-based health insurance claims databases.
• Main study objective:
  Primary objective: Describe the prevalence of major congenital malformations (MCMs) in infants born alive to pregnant individuals with a diagnosis of UC who are (1) exposed to etrasimod during pregnancy (Etrasimod Cohort) and (2) unexposed to etrasimod but exposed to other advanced UC treatments during pregnancy (Other Advanced UC Treatments Cohort) and compare the prevalence between cohorts if sample size permits; ; Secondary objective: Describe the prevalence of pregnancy (spontaneous abortion, pregnancy termination, gestational hypertension, pre-eclampsia, eclampsia, and stillbirth) and infant (preterm birth and small for gestational age) outcomes among individuals in the Etrasimod Cohort and the Other Advanced UC Treatments Cohort and compare the prevalence between cohorts if sample size permits;
• Setting:
  All qualifying pregnancies during the study period within two US-based health insurance claims databases among individuals with UC who are exposed to etrasimod during pregnancy or individuals with UC who are not exposed to etrasimod but who are exposed to other advanced UC treatments during pregnancy will be included.
• Comparators:
  Cohort of individuals with UC who are unexposed to etrasimod but are exposed to other advanced UC treatments during pregnancy.
• Outcomes:
  The primary outcome of this study is major congenital malformation (MCM).
• Data analysis plan:
  Participant characteristics will be summarized with descriptive statistics for each cohort. Comparative analyses will be conducted for each outcome if sample size permits. One interim report will describe accrual of eligible patients into each of the study cohorts. The interim report will also describe each cohort according to key outcome characteristics and outcome counts. The final report will provide the same cohort descriptions, as well as the prevalence of each study outcome by cohort. If sample size permits, the final report will also include a comparative analysis utilizing inverse probability of treatment weighting that estimates the relative prevalence of each of the study outcomes, with the primary analysis of MCMs restricted to cases confirmed by medical record review. All analyses will be conducted and reported separately by data source, and a meta-analysis combining results across databases will also be performed.