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

Systematic review and meta-analysis
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

BELIMUMAB

Additional medical condition(s)

SLE and pregnancy
Population studied

Short description of the study population

Adults subjects diagnosed with systemic lupus erythematosus (SLE) who become pregnant while exposed to belimumab during phase 2-4 clinical trials.
Inclusion criteria:
- All cases involving a pregnant patients are included.

Exclusion criteria:
- Cases involving females over 60 years of age and adult males (where the case was not reported as a partner pregnancy) has been excluded.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Immunocompromised
Other
Pregnant women

Special population of interest, other

Patients with systemic lupus erythematosus

Estimated number of subjects

85
Study design details

Main study objective

To evaluate maternal, fetal and infant outcome data for subjects with systemic lupus erythematosus (SLE) who were exposed to belimumab during pregnancy.

Outcomes

The primary objective is to determine if there is an increase in birth defects in infants born to women with SLE who were exposed to belimumab during pregnancy. Secondary outcomes include adverse maternal and infant outcomes, e.g. spontaneous miscarriage, preterm birth and still birth.

Data analysis plan

All data will be summarized using descriptive statistics. Continuous variables will be summarized by number of participants, mean, standard deviation, median, lower quartile, upper quartile, minimum and maximum unless otherwise stated. Categorical variables will be summarized by number and percentage in each category. Missing data will be displayed as a separate category where appropriate. The denominator for all percentages will reflect the number of participants within the cohort, unless otherwise stated (e.g. excluding lost to follow-up (LTF)). For primary endpoint birth defects and secondary endpoints (pregnancy outcomes: live birth, neonatal death, stillbirth, spontaneous miscarriage, elective termination, ectopic pregnancy, and molar pregnancy) prevalence rates and 95% confidence intervals will be summarized.