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

Study type

• Study topic:
  Disease /health condition
• Study topic, other:
  Inflammatory Bowel Disease
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SKYRIZI
• Study drug International non-proprietary name (INN) or common name:
  RISANKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC18) risankizumab

  risankizumab
• Medical condition to be studied:
  Inflammatory bowel disease

Population studied

• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  600

Study design details

• Study design:
  The study will be a population-based, non-interventional, cohort study of pregnant women with moderate-to-severe Inflammatory Bowel Disease (IBD). The primary comparison will be among women with moderate-to-severe IBD exposed to risankizumab versus those exposed to the comparator treatment group.
• Main study objective:
  The study aim is to evaluate the safety of risankizumab during pregnancy in women with moderate-to-severe IBD. The outcomes of this cohort study are major congenital malformations (MCMs) of the infant among live birth pregnancies, Pregnancy outcomes: live birth, spontaneous abortion, elective abortion, stillbirth and Infant outcomes: premature birth, small for gestational age (SGA), neonatal deaths, serious infections.;
• Data analysis plan:
  The prevalence (%) of the main outcome (MCMs) and additional outcomes, including other adverse infant outcomes and pregnancy outcomes (live birth, spontaneous abortion, elective abortion, stillbirth), and their 95% confidence intervals (CIs) will be calculated among eligible risankizumab-exposed pregnancies and the corresponding matched comparator biologic-exposed pregnancies.