Meta-Analysis Plan for Study Number 201182, GSK1550188, SLE, Pregnancy Analysis

Trial description: SLE is an autoimmune disease typically affecting women of childbearing age that can be associated with significant maternal and fetal morbidity. Belimumab is a biologic approved as adjunctive therapy for SLE. Although pregnant women wereexcluded from belimumab clinical trials and treatment was discontinued if a pregnancy occurred, pregnancy outcomes were collected when a pregnancy was identified.This study is a metaanalysis, observational cohort study to describe pregnancy outcomes including birth defects, live births (term and preterm), stillbirth, spontaneous miscarriage, and elective termination in women who conceived while participating in belimumab phase 2-4 clinical trial studies. These Pregnancy outcomes were evaluated with respect to maternal age, race and ethnicity, disease activity, concomitant medications,and timing of belimumab exposure.Cumulative pregnancy outcome data (when available) from women who conceived while participating in belimumab SLE phase 2-4 clinical trials was obtained from the belimumab clinical trail database and the GSK safety database.