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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants exposed to deucravacitinib for the full pregnancy duration |
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| Cohort 2 | Participants exposed to deucravacitinib for the first trimester |
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| Cohort 3 | Participants exposed to deucravacitinib for the first 20 weeks of gestation |
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| Cohort 4 | Participants exposed to other systemic psoriasis medications for the full pregnancy duration |
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| Cohort 5 | Participants exposed to other systemic psoriasis medications for the first trimester |
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| Cohort 6 | Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | As per product label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of infants born with Major Congenital Malformations (MCMs) | 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) | Up to 12 months after birth or date of health plan disenrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcomes | Incidence of the following pregnancy outcomes: spontaneous abortion, induced abortion, ectopic pregnancy, stillbirth, pre-eclampsia, eclampsia and gestational diabetes | Up to 9 months or date of health plan disenrollment |
| Infant outcomes |
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Inclusion Criteria:
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
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This study will include women aged 15 through 50 years with psoriasis who become pregnant (based on their estimated date of conception) from 09-Sep-2022 through 31-Oct-2026 that have been identified in the Optum Research Database (ORD).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol-Meyers Squibb | Lawrenceville | New Jersey | 08648 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Cohort 7 | Participants not exposed to any systemic medications for the full pregnancy duration |
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| Cohort 8 | Participants not exposed to any systemic medications during the first trimester |
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| Cohort 9 | Participants not exposed to any systemic medications during the first 20 weeks of gestation |
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| Systemic psoriasis medications |
| Drug |
As per product label |
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| No systemic medications | Other | Participants not exposed to any systemic medications |
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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 |
| Up to 12 months after birth or date of health plan disenrollment |