The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring. The study is seeking participants who: * Are currently or recently pregnant * Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy. The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy. Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.
Study Type
OBSERVATIONAL
Enrollment
400
taken by mouth
Pfizer
New York, New York, United States
RECRUITINGPercent of live birth children with major congenital malformations
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Time frame: Enrollment until 12 months after delivery
Percent of participants with children with minor congenital malformations
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Time frame: Enrollment until 12 months after delivery
Percent of participants with spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks.
Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)
Percent of participants with stillbirths
An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
Time frame: Enrollment until end of pregnancy (up to 9 months)
Percentage of participants with an elective termination
A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to fetal abnormalities
Time frame: Enrollment until end of pregnancy (up to 9 months)
Percent of participants with preterm birth
A live birth occurring at \<37 gestational weeks.
Time frame: Enrollment until 12 months after delivery
Percent of participants with children born small for gestational age
Birthweight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Time frame: Enrollment until 12 months after delivery
Percentage of participants with children with postnatal growth deficiency
Weight, length, or head circumference in \<10th percentile for sex and chronological age using standard growth charts
Time frame: Enrollment until 12 months after delivery
Percent of participants with infant developmental delay
Failure to achieve the developmental milestones for chronological age, as defined by the CDC.
Time frame: Enrollment until 12 months after delivery
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