Atopic Dermatitis, Pregnancy Related
Conditions
Keywords
ruxolitinib, Atopic Dermatitis, pruritus, eczema, topical therapy, JAK inhibitor
Brief summary
This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
Interventions
DRUGRuxolitinib Cream
Ruxolitinib Cream
DRUGTCS
Topical corticosteroid
Sponsors
Incyte Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of major congenital malformation (MCM)s | Up to 12 months after birth | Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of small-for-gestational age (SGA) births | At time of delivery | Defined as a birthweight at or below the 10th percentile for a given gestational age. |
| Number of Pregnancy outcomes | Up to birth | Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol. |
Countries
United States
Contacts
Primary ContactIncyte Corporation Call Center (US)
Outcome results
None listed