Observational study of exposure to baricitinib during pregnancy in US-based administrative claims data (I4V-MC-B036)

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

• Name of medicine:
  OLUMIANT
• Study drug International non-proprietary name (INN) or common name:
  BARICITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AF02) baricitinib

  baricitinib

Population studied

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

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  868

Study design details

• Main study objective:
  The 1st objective is to describe demographic and clinical characteristics of pregnant women with evidence of exposure to baricitinib during pregnancy, and to summarize occurrence of the prespecified adverse pregnancy outcomes. The 2nd objective is to estimate the RR of the outcomes among pregnant women with a diagnosis of AA and a dispensing of baricitinib compared to similar women without JAK exposure
• Outcomes:
  Major congenital malformations, recognized spontaneous abortions stillbirth small for gestational age preterm birth
• Data analysis plan:
  The primary objective will be achieved through descriptive statistics. Secondary objective of relative risk will be assessed using propensity score methods to adjust for potential confounding.