Tofacitinib Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project (OTIS PASS Tofacitinib)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Xeljanz
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

  Colitis ulcerative

Population studied

• 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:
  300

Study design details

• Main study objective:
  The main objective of the study is to conduct an observational cohort study that will involve follow-up of live born infrants to one year of age to assess the potential increase in the risk of birth defects in pregnancies exposed to tofacitinib compared with an unexposed comparator population.
• Outcomes:
  The primary outcome variable is major structural defects. Secondary outcomes include: minor structural defects, spontaneous abortions, stillbirth, premature delivery, small for gestational age, postnatal growth deficiency, loss to follow-up, serious or opportunistic infections and malignancies.
• Data analysis plan:
  The primary analysis for the cohort study will be a comparison of the birth prevalence of major structural defects in live born infants between the tofacitinib-exposed group and the primary comparator group. This analysis will use chi-square or Fisher’s Exact test for univariate comparisons and logistic regression or Cochran-Mantel-Haenzsel test for multivariate analysis (ie, adjustment of possible confounders including demographics and disease duration).