Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry

Abstract

Background Belimumab is approved for active, autoantibody‐positive systemic lupus erythematosus (SLE) and lupus nephritis, but limited data exist regarding its use in pregnancy. The Belimumab Pregnancy Registry (BPR, GSK Study BEL114256; NCT01532310) was created to evaluate pregnancy and infant outcomes following belimumab exposure. Methods Individuals with SLE exposed to belimumab from 4 months before and/or during pregnancy can enroll into the BPR. The primary outcome is major birth defects; secondary outcomes include miscarriages, stillbirths, elective termination, pre‐term birth, neonatal death, small for gestational age, and adverse infant outcomes during the first year of life. Belimumab exposure timing, concomitant medications, and other potential confounding factors are also collected. Data up to March 8, 2021, are reported descriptively. Results From an expected sample size target of 500 prospective pregnancies with a known outcome, only 55 were enrolled in the study. Among these, two pregnancy losses and 53 pregnancies with a live birth outcome were reported. Ten of the 53 live birth pregnancies resulted in a major birth defect. Ten pregnancies were enrolled after the pregnancy outcome occurred and were examined retrospectively (four live births with no defects, four miscarriages, and two elective terminations). There was no indication or pattern of birth defects associated with belimumab. Conclusions Low recruitment numbers for the BPR and incomplete information limit the conclusions regarding belimumab exposure during pregnancy. There was no pattern or common mechanism of birth defects associated with belimumab within the BPR data.

Considering belimumab during pregnancy: A more viable option over time

“…Table 1 summarises the main disease characteristics of the 12 women included. The median age of the pregnant patients was 37 years (IQR 31, [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. Five patients had antiphospholipid antibodies and one had an overlap with mixed connective tissue disease.…”

“…After searching MEDLINE and EMBASE databases, 10 case reports and case series (Table 4) and five registries (Table 5) were identified (the paper of Juliao et al 27…”

“…After searching MEDLINE and EMBASE databases, 10 case reports and case series ( Table 4 ) and five registries ( Table 5 ) were identified (the paper of Juliao et al 27 is included in Petri et al, 23 so we only comment on the last one). All studies were published between 2014 and 2023.…”

Modern Management of Pregnancy in Systemic Lupus Erythematosus: From Prenatal Counseling to Postpartum Support

“…However, the available data are gradually increasing. An interim analysis of the Belimumab Pregnancy Registry (BPR) was published in 2022, which showed no increased risk of birth defects in children of women exposed to BEL during pregnancy [ 20 ]. These results are in line with other limited case series in the literature [ 21 , 22 , 23 , 24 ].…”

Systemic lupus erythematosus: one year in review 2024

“…Therefore, these data from real-clinical settings suggest a possible role of belimumab as add-on therapy in refractory lupus nephritis in patients of Asian ancestry. About belimumab exposure during pregnancy, a descriptive summary of data from clinical trials, belimumab pregnancy registry(69), and postmarketing/spontaneous reports has been published(70). Available records about birth defects and miscarriages in belimumab-exposed pregnancies were reported.…”