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

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

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.