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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IXEKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC13) ixekizumab

  ixekizumab
• Medical condition to be studied:
  Psoriasis

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • 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:
  830

Study design details

• Study design:
  This administrative claims-based cohort study of ixekizumab exposure during pregnancy will ; include two phases. Phase I: Uptake monitoring. Phase II: Cohort surveillance.
• 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.
• Comparators:
  Comparator group of IL inhibitor medications; guselkumab, secukinumab, brodalumab, and ustekinumab
• 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.