Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Ixekizumab (I1F-MC-B005)

Study type

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

  Drug utilisation

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:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  830

Study design details

• Main study objective:
  To monitor the uptake of ixekizumab among women of childbearing age (ages 15-45), and monitor the incidence of maternal and fetal/infant outcomes among pregnant women exposed to ixekizumab. If sufficient exposures are identified, an additional objective is to study maternal and fetal/infant outcomes among pregnant women exposed to ixekizumab compared to similar women treated with TNF-α inhibitors.
• Outcomes:
  Major congenital malformations of the infant. Pregnancy outcomes: Recognized spontaneous abortions, stillbirths, elective terminations, preterm delivery, and small for gestational age infants.Infant outcomes: Minor congenital anomalies (up to 12 months of age) and serious infections of the infant (up to six months of age).Maternal outcomes: Serious infections during pregnancy and serious peri-partum infections.
• Data analysis plan:
  The number of ixekizumab exposures and outcomes among exposed mother-infant pairs will be provided. If a sufficient number exposures are identified for comparative analysis, incidence rate ratios and birth prevalence ratios (as applicable) and their 95% CI will be calculated comparing ixekizumab exposed pregnancies versus comparator TNF-α inhibitor biologic exposed pregnancies. Sensitivity analyses are planned.