Academic Journal
Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry
| العنوان: | Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry |
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| المؤلفون: | Juliao, Patricia, Wurst, Keele, Pimenta, Jeanne M., Gemzoe, Kim, Landy, Helain, Moody, M. Anthony, Tilson, Hugh, Covington, Deborah, Moore, Tammy, Marino, Rebecca, Gilbride, Jennifer, Liu, Andrew, Meizlik, Paige, Petri, Michelle |
| المساهمون: | GSK |
| المصدر: | Birth Defects Research ; volume 115, issue 2, page 188-204 ; ISSN 2472-1727 2472-1727 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2022 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1002/bdr2.2091 |
| الاتاحة: | http://dx.doi.org/10.1002/bdr2.2091 https://onlinelibrary.wiley.com/doi/pdf/10.1002/bdr2.2091 https://onlinelibrary.wiley.com/doi/full-xml/10.1002/bdr2.2091 |
| Rights: | http://creativecommons.org/licenses/by/4.0/ |
| رقم الانضمام: | edsbas.28D4041D |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/bdr2.2091 |
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