The Belimumab Pregnancy Exposure Study: An OTIS Autoimmune Diseases in Pregnancy Project (213928)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BENLYSTA
• Study drug International non-proprietary name (INN) or common name:
  BELIMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA26) belimumab

  belimumab
• Medical condition to be studied:
  Systemic lupus erythematosus

Population studied

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

  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  11

Study design details

• Main study objective:
  To evaluate belimumab exposure in pregnancy with respect to major birth defects when compared to the background rate in an unexposed SLE cohort.
• Outcomes:
  To monitor planned and unplanned pregnancies exposed to belimumab and to evaluate the possible teratogenic effect of this medication relative to the primary pregnancy outcomes of major birth defects. Secondary outcomes also evaluated in the study include other pregnancy outcomes as well as infant outcomes up to one year of age.
• Data analysis plan:
  The primary comparison will be the proportion of major structural defects between the exposed group (Cohort 1) and the diseased comparison group (Cohort 2) among pregnancies resulting in at least one live born infant. A point estimate of the crude (i.e. unadjusted) risk ratio (RR) of the exposed group versus the unexposed group, as well as its 95% confidence interval (CI) will be computed using the normal approximation method. When the expected frequency of any of the cells of the contingency table is less than five, the CI will be obtained by an exact method using the software Stat XACT, the method is based on invertingNe an unconditional exact hypothesis test. The comparison will also be carried out within each of two strata, according to whether the woman had prenatal diagnostic testing, such as level II ultrasound, amniocentesis or chorionic villus sampling, prior to enrollment in the study or not.