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

Adolescents (12 to < 18 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).