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

Launched by INCYTE CORPORATION · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the use of ruxolitinib cream for treating atopic dermatitis (a skin condition) during pregnancy affects the health of infants, compared to the use of topical corticosteroids (another type of skin treatment). Essentially, researchers want to understand if there are any differences in infant health outcomes between mothers who used ruxolitinib cream and those who used corticosteroids during their pregnancies.

To participate in this study, women must be at least 14 years old and have been prescribed either ruxolitinib cream or a topical corticosteroid during their pregnancy. They also need to have a diagnosis of atopic dermatitis before or at the start of their treatment. If eligible, participants can expect their and their infants' health data to be analyzed, with follow-ups for infant health up to a year after birth. It's important to know that only mothers whose data can be linked to their infants will be included in the analysis for infant outcomes. This trial is currently in the recruiting phase, aiming to gather important information for future pregnancies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged 14 years or older at pregnancy outcome.
• • Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
• • At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
• • A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
• • Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
• • For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.
• Exclusion Criteria:
• • • One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.