Lupus & antiphospholipid syndrome
Dilemma of belimumab therapy (dis)continuation during pregnancy: Results of a retrospective study in eudravigilance
Main finding · Foetal deathResult — go to the resultOdds ratio 1.27 95% CI 0.48–3.32Authors' conclusion
The positive results of our study are supportive for the continuation of belimumab during pregnancy.
Study context
- Population
- Belimumab-exposed pregnancy-related reports in systemic lupus erythematosus (SLE) patients, EudraVigilance database until March 11th, 2021
- Exposure
- Belimumab stopped within the first trimester vs belimumab continued during the first trimester or thereafter
- Outcome
- Foetal outcomes: live birth or foetal death (miscarriage or stillbirth)
Methodological detailsspontaneous reports, EudraVigilance database
- Spontaneous reports
- EudraVigilance database
Main finding
Foetal death
Odds ratio
1.27
95% CI 0.48–3.32
Events by group
Group Bvs Group A
OR 1.27 (95% CI 0.48–3.32)
As reported in the abstract
Observational data: associations, not effects.
Further findings
Preterm birth and low birth weight reporting rates
- Higher in group A, though not statistically different
Original publication
Dilemma of belimumab therapy (dis)continuation during pregnancy: Results of a retrospective study in eudravigilance. Lupus. Published 30 November 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →