000			03475nam a22003737a 4500
008			221027s20222022 xxu||||| |||| 00| 0 eng d
022			_a0003-4967
024			_a10.1136/ard-2022-222505 [doi]
024			_aard-2022-222505 [pii]
040			_aOvid MEDLINE(R)
099			_a36198440
245			_aBelimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports.
251			_aAnnals of the Rheumatic Diseases. 2022 Oct 05
252			_aAnn Rheum Dis. 2022 Oct 05
253			_aAnnals of the rheumatic diseases
260			_c2022
260			_fFY2023
260			_p2022 Oct 05
265			_saheadofprint
266			_d2022-10-27
520			_aCONCLUSIONS: Observations reported here add to limited data published on pregnancy outcomes following belimumab exposure. Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use. Copyright © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
520			_aMETHODS: Data collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports up to 8 March 2020 were described. Belimumab exposure timing, concomitant medications and potential confounding factors were summarised descriptively.
520			_aOBJECTIVE: Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab.
520			_aRESULTS: Among 319 pregnancies with known outcomes (excluding elective terminations), 223 ended in live births from which birth defects were identified in 4/72 (5.6%) in belimumab-exposed pregnancies and 0/9 placebo-exposed pregnancies across 18 clinical trials, 10/46 (21.7%) belimumab-exposed pregnancies in the BPR prospective cohort (enrolled prior to pregnancy outcome) and 0/4 belimumab-exposed pregnancies in the BPR retrospective cohort (enrolled after pregnancy outcome), and 1/92 (1.1%) in belimumab-exposed pregnancies from postmarketing/spontaneous reports. There was no consistent pattern of birth defects across datasets. Out of pregnancies with known outcomes (excluding elective terminations), pregnancy loss occurred in 31.8% (35/110) of belimumab-exposed women and 43.8% (7/16) of placebo-exposed women in clinical trials; 4.2% (2/48) of women in the BPR prospective cohort and 50% (4/8) in the BPR retrospective cohort; and 31.4% (43/137) of belimumab-exposed women from postmarketing/spontaneous reports. All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data.
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 _bMWHC
790			_aClowse MEB, Connolly MB, Gemzoe K, Harris J, Juliao P, Khamashta M, Kurtinecz M, Landy H, Levy RA, Liu A, Marino R, Meizlik P, Petri M, Pimenta JM, Quasny H, Roth DA, Sumner K, Tilson H, Wurst K
856			_uhttps://dx.doi.org/10.1136/ard-2022-222505 _zhttps://dx.doi.org/10.1136/ard-2022-222505
942			_cART _dArticle
999			_c205 _d205