ArticleBirth defects research2023
Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry.
Article in Birth defects research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01532310 (WEUKBRE6076), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- The Asia Pacific League of Associations for Rheumatology (APLAR) Consensus Statements for the Management of Reproductive Issues in Autoimmune Rheumatic Diseases.International journal of rheumatic diseases · 2026Pooled it
- Systemic Lupus Erythematosus in Pregnancy.Medical sciences (Basel, Switzerland) · 2025Pooled it
- Efficacy of telitacicept in a refractory systemic lupus erythematosus patient with lupus nephritis and subsequent pregnancy: a case-based review.Clinical rheumatology · 2026Review
- Systemic lupus erythematosus and pregnancy: a comprehensive clinical review of maternal, fetal, and treatment considerations.Advances in rheumatology (London, England) · 2026Review
- Monoclonal Antibodies in Pregnancy of Patients with Systemic Lupus Erythematosus: Friend or Foe? A Case Report of a Patient with Multiple Pregnancies.Antibodies (Basel, Switzerland) · 2026Article
- The Evolution of Lupus Nephritis Therapy from the 1960s to the Present.Bioengineering (Basel, Switzerland) · 2026Review
- Use of Biologics During Pregnancy Among Patients With Autoimmune Conditions.JAMA network open · 2025Article
- Role of belimumab in recurrent spontaneous abortions amongst patients with lymphocyte dysfunction: a retrospective case-control study.BMC pregnancy and childbirth · 2025Article
- Modern Management of Pregnancy in Systemic Lupus Erythematosus: From Prenatal Counseling to Postpartum Support.Journal of clinical medicine · 2024Review
- Observational
- Effect of remission, clinical remission with active serology, and glucocorticoid dosage on the pregnancy outcome of pregnant patients with systemic lupus erythematosus.Arthritis research & therapy · 2024Article
- A retrospective analysis of the safety of tacrolimus use and its optimal cut-off concentration during pregnancy in women with systemic lupus erythematosus: study from two Japanese tertiary referral centers.Arthritis research & therapy · 2024Article
- Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry.Birth defects research · 2023Article
Corrections and comments
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Authors and funding
14 authors at 11 institutions in 2 countries.
Funding
Abstract
backgroundBelimumab 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.
methodsIndividuals 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.
resultsFrom 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.
conclusionsLow 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.