A Post-Authorization Safety Study to Evaluate the Safety of Abrocitinib Exposure During Pregnancy in United States Healthcare Databases

Study type

• 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:
  CIBINQO
• Study drug International non-proprietary name (INN) or common name:
  ABROCITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH08) abrocitinib

  abrocitinib
• Additional medical condition(s):
  Moderate-to-severe atopic dermatitis (AD)

Population studied

• Short description of the study population:
  The study population will include singleton pregnancies among women 12 to 49 years of age diagnosed with moderate-to-severe AD who are members of participating Sentinel Data Partners (DPs).
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  This US population-based, non-interventional, cohort study will evaluate the risk of adverse pregnancy and infant outcomes among women with moderate-to-severe AD who are exposed to abrocitinib during pregnancy compared to those unexposed during pregnancy.
• Main study objective:
  To describe and compare the adverse pregnancy and infant outcomes among women with moderate-to-severe AD who are exposed to abrocitinib during pregnancy and women with moderate-to-severe AD who are not exposed to; abrocitinib.
• Setting:
  The study will be conducted using data provided by US Data Partners in the FDA’s Sentinel System. The study population will include singleton pregnancies among women 12 to 49 years of age diagnosed with moderate-to-severe AD who are members of participating Sentinel Data Partners (DPs).
• Outcomes:
  The main outcome of interest will be MCMs. Additional outcomes of interest include other adverse infant outcomes (preterm birth, SGA) and pregnancy outcomes (stillbirth, spontaneous abortion).