Psoriasis
Conditions
Keywords
Psoriasis
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.
Interventions
DRUGDeucravacitinib
As per product label
DRUGSystemic psoriasis medications
As per product label
OTHERNo systemic medications
Participants not exposed to any systemic medications
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of infants born with Major Congenital Malformations (MCMs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy outcomes | Up to 9 months or date of health plan disenrollment | Incidence of the following pregnancy outcomes: spontaneous abortion, induced abortion, ectopic pregnancy, stillbirth, pre-eclampsia, eclampsia and gestational diabetes |
| Infant outcomes | Up to 12 months after birth or date of health plan disenrollment | Incidence of the following infant outcomes: small for gestational age, large for gestational age, low birthweight, preterm birth, serious or opportunistic infections, postnatal growth deficiency, infant developmental deficiency, neonatal hospitalization, and infant/neonatal/perinatal death |
Countries
United States
Outcome results
None listed