Study of Pregnancy Outcomes in Women with Atopic Dermatitis Using Ruxolitinib Cream Compared to Topical Corticosteroids

What this Trial Is About

Researchers are evaluating infant outcomes in women with atopic dermatitis AD who used ruxolitinib cream during pregnancy compared to those who used topical corticosteroids TCS. This observational retrospective cohort study uses data from US claims databases to assess safety and outcomes related to these treatments in pregnant women with AD. The study is sponsored by Incyte Corporation and focuses on pregnancy-related effects and infant health outcomes. The study observes two groups infants born to women exposed to ruxolitinib cream during pregnancy and infants born to women exposed to topical corticosteroids before or during pregnancy. Women must have had at least one pharmacy claim for either ruxolitinib cream or a TCS, with continuous enrollment in the database from six months before conception through the end of pregnancy. Infant data are linked to maternal records and followed for up to one year after birth to assess outcomes. Participants will have their data reviewed for major congenital malformations up to 12 months after birth, small-for-gestational-age births at delivery, and overall pregnancy outcomes up to birth. The study excludes women who had pharmacy claims for oral ruxolitinib or other JAK inhibitors during the exposure window. Continuous enrollment in the database allows for detailed tracking of infant health and pregnancy outcomes over time.

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis