Post-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data

Study type

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

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ADTRALZA
• Name of medicine, other:
  Adbry
• Study drug International non-proprietary name (INN) or common name:
  TRALOKINUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH07) tralokinumab

  tralokinumab
• Medical condition to be studied:
  Dermatitis atopic

Population studied

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

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  11880

Study design details

• Main study objective:
  The study will investigate whether maternal exposure to tralokinumab during pregnancy in women with AD is associated with an increased risk of major congenital malformations, minor congenital malformations, infants born small for gestational age, preterm births, spontaneous abortions, or stillbirths relative to non-exposure to tralokinumab during pregnancy.
• Outcomes:
  Primary outcomes: Major congenital malformations; Secondary outcomes: Minor congenital malformations, infants born small for gestational age, preterm births, spontaneous abortions, stillbirths
• Data analysis plan:
  Descriptive analyses will be conducted for the progress reports to monitor counts of tralokinumab-exposed pregnancies and live births. The following analyses will be conducted for the final study report: • Descriptive analyses of demographic and baseline characteristics and the number of dispensations of the exposure medications will be conducted for each cohort and will include counts, frequency, mean and 95% CI, median, Q1 and Q3, minimum, and maximum. Results will be presented by data source. • Comparative analyses, including crude and adjusted RRs and risk differences and 95% CIs will be calculated for all pregnancy and infant outcomes by data source. • For each study outcome, the effect estimates from each data source will be pooled using meta-analytic techniques.