Lupus & antiphospholipid syndrome
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
Authors' conclusion
Observations reported here add to limited data published on pregnancy outcomes following belimumab exposure.
Study context
- Population
- Women with systemic lupus erythematosus (SLE) exposed to belimumab during pregnancypregnancies with known outcomes
- Participants
- 319 pregnancies
- Exposure
- Belimumab-exposed vs placebo-exposed pregnancies (clinical trials); belimumab-exposed pregnancies in the Belimumab Pregnancy Registry (BPR) and postmarketing reports
- Outcome
- Birth defects and pregnancy loss
Methodological detailsdata up to 8 March 2020, All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data
- Data up to 8 March 2020
- All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data
Main finding
As reported in the abstract
Birth defects among live births
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Pregnancy lossExcluding elective terminations | Belimumab (clinical trials) 31.8% · Placebo (clinical trials) 43.8% · BPR prospective 4.2% · BPR retrospective 50% · Postmarketing/spontaneous reports 31.4% |
- Pregnancy loss: denominators: 110, 16, 48, 8, 137
Original publication
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports. Ann Rheum Dis. Published 5 October 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →