Research question: Is there an increased risk of adverse maternal and/or infant outcomes in individuals with AA exposed to ritlecitinib during pregnancy?
Primary objective: To estimate the prevalence of major congenital malformation [MCM] births (primary outcome) among pregnant individuals with alopecia areata [AA] who are (1) exposed to ritlecitinib (exposed cohort) and (2) unexposed to ritlecitinib (comparator cohort).
Secondary objectives: 1. To estimate the prevalence of the following secondary outcomes in the 2 cohorts: SAB, elective termination, pregnancy complications (pre-eclampsia, eclampsia), stillbirth, preterm birth, SGA, minor congenital malformation, infant postnatal growth deficiency, and infant developmental delay. 2. To estimate the RR of each of the study outcomes in the exposed versus unexposed cohorts, 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, elective termination, pregnancy complications (pre-eclampsia, eclampsia), stillbirth, preterm birth, SGA, minor congenital malformation, postnatal growth deficiency, and infant developmental delay. The main measures of effect are the prevalence of each outcome in the 2 study cohorts and, if sample size permits, the RR of each outcome, comparing the cohorts.