TY - JOUR
T1 - Belimumab use during pregnancy
T2 - Interim results of the belimumab pregnancy registry
AU - Juliao, Patricia
AU - Wurst, Keele
AU - Pimenta, Jeanne M.
AU - Gemzoe, Kim
AU - Landy, Helain
AU - Moody, M. Anthony
AU - Tilson, Hugh
AU - Covington, Deborah
AU - Moore, Tammy
AU - Marino, Rebecca
AU - Gilbride, Jennifer
AU - Liu, Andrew
AU - Meizlik, Paige
AU - Petri, Michelle
N1 - Publisher Copyright:
© 2022 GSK. Birth Defects Research published by Wiley Periodicals LLC.
PY - 2023/1/15
Y1 - 2023/1/15
N2 - 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.
AB - 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.
KW - belimumab
KW - major birth defects
KW - pregnancy
KW - systemic lupus erythematosus
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U2 - 10.1002/bdr2.2091
DO - 10.1002/bdr2.2091
M3 - Article
C2 - 36177676
AN - SCOPUS:85139010390
SN - 2472-1727
VL - 115
SP - 188
EP - 204
JO - Birth Defects Research
JF - Birth Defects Research
IS - 2
ER -