Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
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Le résumé fourni par la source
OBJECTIVE: Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab. 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. 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. 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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
- Date Crossref
- 01/02/2023
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Johns Hopkins University Rheumatology pays non établi dans la noticeUniversité ou école supérieure
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Johns Hopkins Medicine pays non établi dans la noticeÉtablissement de santé
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Center for Rheumatology pays non établi dans la noticeStructure de recherche
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Georgetown University Department of Obstetrics and Gynecology pays non établi dans la noticeUniversité ou école supérieure
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Georgetown University Medical Center pays non établi dans la noticeÉtablissement de santé
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Society for Maternal-Fetal Medicine pays non établi dans la noticeOrganisation à but non lucratif
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MedStar Georgetown University Hospital pays non établi dans la noticeÉtablissement de santé
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Duke University Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Health Economics and Outcomes Research (United Kingdom) pays non établi dans la noticeEntreprise
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Evidence (Italy) pays non établi dans la noticeEntreprise
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Dubai Medical College pays non établi dans la noticeUniversité ou école supérieure
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Cancer Research And Biostatistics pays non établi dans la noticeOrganisation à but non lucratif
Rheumatology — Johns Hopkins University, Johns Hopkins Medicine et Center for Rheumatology, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.