Pregnancy Exposures and Outcomes in Women with Psoriasis Treated with Risankizumab: A Cohort Study Utilizing Large Electronic Healthcare Databases with Mother-Baby Linkage in the United States

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SKYRIZI
• Medical condition to be studied:
  Psoriasis

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The study aim is to evaluate the safety of risankizumab during pregnancy in women with psoriasis.
• Outcomes:
  The primary outcome of this cohort study is major congenital malformations of the infant among live birth pregnancies. Secondary outcomes include the following: ● Pregnancy outcomes: live birth, spontaneous abortion, elective abortion, stillbirth ● Infant outcomes: premature birth, small for gestational age (SGA), neonatal deaths, serious infections
• Data analysis plan:
  This study will estimate the incidence (cumulative risks) of pregnancy outcomes, including live births, spontaneous abortions, elective abortion, and stillbirths and will compare the occurrence of these events among risankizumab-exposed women with those among the matched comparator biologic-exposed women. AbbVie will use a log binomial distribution with robust variance using generalized estimating equations to estimate the effects of exposure (cumulative risk ratios and 95% confidence intervals) to risankizumab.