Deucravacitinib Pregnancy Study: A Retrospective Observational Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 833
- Locations
- 1
- Primary Endpoint
- Number of infants born with Major Congenital Malformations (MCMs)
Study Overview
Brief Summary
This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Maternal age 15 through 50 years at date of conception
- •Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
- •Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
- •Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy
Exclusion Criteria
- •Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window
Arms & Interventions
Cohort 1
Participants exposed to deucravacitinib for the full pregnancy duration
Intervention: Deucravacitinib (Drug)
Cohort 2
Participants exposed to deucravacitinib for the first trimester
Intervention: Deucravacitinib (Drug)
Cohort 3
Participants exposed to deucravacitinib for the first 20 weeks of gestation
Intervention: Deucravacitinib (Drug)
Cohort 4
Participants exposed to other systemic psoriasis medications for the full pregnancy duration
Intervention: Systemic psoriasis medications (Drug)
Cohort 5
Participants exposed to other systemic psoriasis medications for the first trimester
Intervention: Systemic psoriasis medications (Drug)
Cohort 6
Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
Intervention: Systemic psoriasis medications (Drug)
Cohort 7
Participants not exposed to any systemic medications for the full pregnancy duration
Intervention: No systemic medications (Other)
Cohort 8
Participants not exposed to any systemic medications during the first trimester
Intervention: No systemic medications (Other)
Cohort 9
Participants not exposed to any systemic medications during the first 20 weeks of gestation
Intervention: No systemic medications (Other)
Outcomes
Primary Outcomes
Number of infants born with Major Congenital Malformations (MCMs)
Time Frame: Up to 12 months after birth or date of health plan disenrollment
MCMs defined as a structural abnormality with surgical, medical, or cosmetic importance (excluding chromosomal abnormalities or physiological features due to complications of prematurity, such as cryptorchidism, inguinal hernia, or isolated patent ductus arteriosus in infants born less than 37 weeks of gestation)
Secondary Outcomes
- Pregnancy outcomes(Up to 9 months or date of health plan disenrollment)
- Infant outcomes(Up to 12 months after birth or date of health plan disenrollment)