A Registry-Based Observational Study to Assess Maternal, Pregnancy, and Infant Outcomes Following Exposure to Ixekizumab (I1F-MC-B010)

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

• Study drug International non-proprietary name (INN) or common name:
  IXEKIZUMAB
• Medical condition to be studied:
  Psoriasis

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  716

Study design details

• Main study objective:
  To estimate the relative birth prevalence of major congenital malformations (up to 12 months) among infants born to women exposed to ixekizumab during the first trimester of pregnancy as compared to similar women who are (a) exposed to a TNF inhibitor during the first trimester of pregnancy, or (b) unexposed to biologics or other systemic disease modifying anti-rheumatic drugs during pregnancy
• Outcomes:
  Major congenital malformations, Pregnancy, infant, and maternal outcomes
• Data analysis plan:
  Descriptive analyses will be generated for all enrolled women and infants. Baseline tables will describe attrition, timing of exposure, number of pregnancies with known outcome at time of enrollment, the number of women with prenatal screening prior to enrollment, and the mother’s baseline characteristics. A descriptive summary of study outcomes will also be provided, with serious infections and malformations presented as composite and individual outcomes. Comparative analyses will be conducted separately for each outcome and will include adjustment for confounding and any relevant sensitivity analyses. For all comparative analyses, ixekizumab will be the treatment of interest. The TNFi and unexposed cohorts will be the reference cohorts. Comparative analyses will be performed once there is adequate power, or for the final report, whichever comes first. The point estimate and precision for each outcome will be provided.