000			02943nam a22003497a 4500
008			221027s20222022 xxu||||| |||| 00| 0 eng d
024			_a10.1002/bdr2.2091 [doi]
040			_aOvid MEDLINE(R)
099			_a36177676
245			_aBelimumab use during pregnancy: Interim results of the belimumab pregnancy registry.
251			_aBirth Defects Research. 2022 Sep 30
252			_aBirth Defects Res Part A Clin Mol Teratol. 2022 Sep 30
253			_aBirth defects research
260			_c2022
260			_fFY2023
260			_p2022 Sep 30
265			_saheadofprint
266			_d2022-10-27
520			_aBACKGROUND: 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.
520			_aCONCLUSIONS: 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. Copyright © 2022 GSK. Birth Defects Research published by Wiley Periodicals LLC.
520			_aMETHODS: 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.
520			_aRESULTS: 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.
546			_aEnglish
650			_aIN PROCESS -- NOT YET INDEXED
651			_aMedStar Washington Hospital Center
656			_aObstetrics and Gynecology/ Maternal-Fetal Medicine
657			_aJournal Article
700			_aLandy, Helain
790			_aCovington D, Gemzoe K, Gilbride J, Juliao P, Landy H, Liu A, Marino R, Meizlik P, Moody MA, Moore T, Petri M, Pimenta JM, Tilson H, Wurst K
856			_uhttps://dx.doi.org/10.1002/bdr2.2091 _zhttps://dx.doi.org/10.1002/bdr2.2091
942			_cART _dArticle
999			_c200 _d200