An observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated with etanercept or other biologics using merged data from Sweden, Denmark and Finland

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriasis

  Ankylosing spondylitis

Population studied

• Short description of the study population:
  Pregnant women with diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondyloarthritis (AS); for the etanercept treated cohort women who had any treatment with etanercept within 3 months prior to the first day of the last menstrual period (LMP) or any time during pregnancy were included.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1300000

Study design details

• Main study objective:
  To compare the risk of adverse birth outcomes in women exposed to etanercept during pregnancy to those not exposed.
• Outcomes:
  Major congenital malformations, Any congenital malformation, preterm birth, small for gestational age, infant infections
• Data analysis plan:
  All birth in Sweden, Denmark and Finland between July 2006 and 2013 will be included. Birth outcomes for infants born to women with etanercept treatment will be compared to those without.