MARC details
| 000 -LEADER |
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| fixed length control field |
03475nam a22003737a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
221027s20222022 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0003-4967 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1136/ard-2022-222505 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
ard-2022-222505 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
36198440 |
| 245 ## - TITLE STATEMENT |
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| Title |
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports. |
| 251 ## - Source |
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| Source |
Annals of the Rheumatic Diseases. 2022 Oct 05 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Ann Rheum Dis. 2022 Oct 05 |
| 253 ## - Journal Name |
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| Journal name |
Annals of the rheumatic diseases |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2022 Oct 05 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2022-10-27 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: 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 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: 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 ## - SUMMARY, ETC. |
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| Abstract |
OBJECTIVE: Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: 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 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Obstetrics and Gynecology/ Maternal-Fetal Medicine |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Landy, Helain |
| Institution Code |
MWHC |
| 790 ## - Authors |
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| All authors |
Clowse 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 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1136/ard-2022-222505">https://dx.doi.org/10.1136/ard-2022-222505</a> |
| Public note |
https://dx.doi.org/10.1136/ard-2022-222505 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
