Overview
Psoriasis is a skin disorder wherein skin cells multiply faster than normal, making the skin itchy and look patchy and red. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. The main objective of this study is to assess maternal, fetal, and infant outcomes of women who are exposed to risankizumab during pregnancy with those in an unexposed comparator population.
Risankizumab is an approved drug for the treatment of Plaque Psoriasis. Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States.
Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery
There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.
Eligibility
Inclusion Criteria:
Risankizumab-Exposed Cohort
- US resident.
- Current pregnancy.
- Diagnosis of plaque psoriasis.
- Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
Diseased Comparison Cohort
- US resident.
- Current pregnancy.
- Diagnosis of plaque psoriasis.
- Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
Exclusion Criteria:
Risankizumab-Exposed Cohort
- Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
- Exposure to known teratogens and/or investigational medications during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
- Diagnostic prenatal test results known prior to first contact with the registry coordination center (RCC).
- Inclusion in the analysis population for a prior pregnancy.
Diseased Comparison Cohort
- Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
- Exposure to known teratogens and/or investigational medications during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
- Diagnostic prenatal test results known prior to first contact with the RCC.
- Inclusion in the analysis population for a prior pregnancy.