A Post-Marketing Safety Study to Evaluate the Safety of VELSIPITY® (Etrasimod) Exposure During Pregnancy (C5041043)

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

Study drug and medical condition

• Name of medicine:
  VELSIPITY
• Name of medicine, other:
  Etrasimod
• 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 include two cohorts of pregnant individuals: one cohort of individuals with a diagnosis of moderate-to-severe UC who are exposed to etrasimod at any time during pregnancy and one cohort of individuals with a diagnosis of moderate-to-severe UC who are not exposed to etrasimod during pregnancy. ; To be eligible to participate, a patient must be: A resident of the US or Canada, currently pregnant, 15 to 50 years of age at enrollment, and have a diagnosis of an inflammatory bowel disease.
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  This observational cohort study aims to estimate the prevalence of maternal, fetal, and infant outcomes among individuals with moderate-to-severe UC who are exposed to etrasimod during pregnancy.
• Main study objective:
  The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) among individuals with moderate-to-severe UC who are exposed to etrasimod during pregnancy.; The secondary objectives of the study are:; • To estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with moderate-to-severe UC who are exposed to etrasimod during pregnancy.; • To contextualize the prevalence of outcomes among pregnant individuals who are exposed to etrasimod during pregnancy, estimate the prevalence of all outcomes of interest among pregnant individuals with moderate-to-severe UC who are not exposed to etrasimod during pregnancy.; • If sample size permits, to estimate risk ratio (RR) for each study outcome comparing the outcomes of pregnant individuals with moderate-to-severe UC who are exposed to etrasimod with those who are not exposed to etrasimod.;
• Setting:
  The study will use secondary data collected for the CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR), a prospective pregnancy registry based in the US and Canada. ; The IBD-PR enrolls pregnant individuals diagnosed with inflammatory bowel diseases, including UC, Crohn’s disease, other and unspecified non-infective gastroenteritis and colitis, or indeterminate colitis. ; For this study, participants who are enrolled in the IBD-PR and exposed to etrasimod during pregnancy are eligible for inclusion in the enrolled population, regardless of their IBD diagnosis or severity; however, the analysis population will be limited to those participants who have a diagnosis of moderate-to-severe UC.
• Comparators:
  A cohort of individuals with a diagnosis of moderate-to-severe UC who are not exposed to etrasimod during pregnancy.
• Outcomes:
  The primary outcome of interest is Major congenital malformations (MCMs). The maternal and pregnancy secondary outcomes include minor congenital malformations, pre-eclampsia, eclampsia, spontaneous abortions (SABs), stillbirths, pregnancy terminations, preterm births, small for gestational age, gestational diabetes, pregnancy-induced hypertension, and placental abruption. ; The infant secondary outcomes during the first year of life include postnatal growth deficiency, infant developmental delay, infant hospitalization, infant infections (both serious and non-serious), and infant death.
• 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. ; Supplementary analyses will be conducted that include pregnant individuals who were excluded from the analysis population. ; If sample size permits, subgroup and sensitivity analyses will be performed to examine the extent to which changes in certain methods or assumptions affect the results.