Systemic lupus erythematosus (SLE) is an autoimmune disorder typically affecting women of childbearing age, making it important to understand how underlying disease and treatments affect pregnancy outcomes. Belimumab, a biologic, received regulatory approval in 2011. Given that the agent has been used for a short time, there is little information about its use in pregnancy. Belimumab Pregnancy Registry objectives are to evaluate pregnancy and infant outcomes in women with SLE exposed to commercially supplied belimumab within the 4 months before or during pregnancy or both.
The registry is a multicenter, international, prospective cohort study with voluntary participation. Data collection consists of information documented in medical records. Primary reporters are physicians (belimumab prescriber, obstetric provider, and pediatrician). Primary outcome is birth defects and secondary outcomes include spontaneous miscarriage, live birth (preterm birth, small for gestational age), stillbirth, elective termination, and infant outcomes through age 1 year (serious, clinically significant infections, or both).
As of May 31, 2013, two pregnancy outcomes had been reported in six enrolled participants. One participant, exposed to belimumab 6 weeks preconception, delivered a live-born neonate at 35-5/7 weeks of gestation by repeat cesarean delivery after uterine contractions with no cervical dilation. The second participant, exposed to belimumab approximately 1 week postconception, delivered a live-born neonate at 32-5/7 weeks of gestation after placental abruption. No birth defects were reported.
Registry data will add to current clinical experience with belimumab and assist clinicians and patients in weighing potential risks and benefits of treatment for pregnant patients with SLE.
WEUKBRE6076:GSK1550188; ClinicalTrials.gov NCT01532310.