Registry based observational study to assess pregnancy and infant outcomes following exposure to baricitinib in pregnancy (I4V-MC-B035)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  370

Study design details

• Main study objective:
  The primary objective is to estimate the relative birth prevalence of major congenital malformations at up to 12 months of age among infants born to women with alopecia areata who are exposed to baricitinib during the first trimester as compared to similar women with AA who are unexposed to a JAK inhibitor at any time during pregnancy.
• Outcomes:
  Major congenital malformations, minor congenital malformations, recognizzed spontaneous abortions stillbrirths, elective terminations, small for gestational age, preterm birth, effects on postnatal group and development through the first year of life
• Data analysis plan:
  Descriptive statistics of all participating women and prevalence of all study outcomes will be summarized, overall and by exposure cohort. Propensity score methods will be applied to estimate the relative birth prevalence of outcomes among pregnant women (and infants) with AA exposed to baricitinib during pregnancy compared to similar women with AA whoa re unexposed to a JAKi during pregnancy.