Research question: Is there an increased risk of adverse maternal and/or infant outcomes in individuals with AA exposed to ritlecitinib during pregnancy?
Primary objectives:
1. To estimate the prevalence of MCM births (primary outcome) among individuals with AA who are (1) exposed to ritlecitinib during pregnancy (exposed cohort) and (2) unexposed to ritlecitinib during pregnancy (comparator cohort).
2. To estimate the RR of MCM births in the exposed versus comparator cohort.
Secondary objectives:
1. To estimate the prevalence of the following secondary outcomes in the 2 cohorts: SAB, pregnancy termination, pregnancy complications (gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, eclampsia), stillbirth, preterm birth, SGA, minor congenital malformation, infant serious infection, infant hospitalization, infant death, infant postnatal growth deficiency, and infant developmental delay.
2. To estimate the RR of each of the secondary outcomes in the exposed versus comparator cohort, if sample size permits.
Study design: This registry-based, prospective observational cohort study will enroll and follow pregnant individuals in the US, including individuals with AA exposed to ritlecitinib during pregnancy and individuals with AA unexposed to ritlecitinib during pregnancy. This study will be a new, product-based pregnancy registry. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant individuals and the HCPs involved in their care or the care of their infants.
The primary study outcome is MCM and the secondary outcomes are SAB, pregnancy termination, pregnancy complications (gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, eclampsia), stillbirth, preterm birth, SGA, minor congenital malformation, infant serious infection, infant hospitalization, infant death, infant postnatal growth deficiency, and infant developmental delay.