Lupus & antiphospholipid syndrome
Certolizumab pegol to prevent adverse pregnancy outcomes in patients with antiphospholipid syndrome and lupus anticoagulant (IMPACT): results of a prospective, single-arm, open-label, phase 2 trial
Authors' conclusion
Certolizumab appears effective in preventing placenta-mediated adverse outcomes in high-risk patients with APS.
Study context
- Population
- Pregnant patients with antiphospholipid syndrome (APS) and lupus anticoagulant (high-risk pregnancies)45 in primary analysis
- Participants
- 51 patients
- Exposure
- Certolizumab pegol (gestational weeks 8–28) added to low molecular weight heparin plus low dose aspirin vs historical controls
- Outcome
- Primary APO (excluding pregnancy loss <10 weeks or genetic fetal loss)
Methodological detailsprospective, open-label, historical controls, Target sample size 45; expected adverse pregnancy outcome (APO) rate 20% with certolizumab vs 40% in historical controls
- Prospective
- Open-label
- Historical controls
- Target sample size 45; expected APO rate 20% with certolizumab vs 40% in historical controls
Main finding
As reported in the abstract
Certolizumab
20%
9 events
Observational data: associations, not effects.
Further findings
- Gestational age at delivery — Certolizumab
- median 36.5 weeks
Primary APO, all enrolled patients
- Primary APO among 51 enrolled patients
- 9 (17.6%; 95% CI, 8.4%-30.9%)
Gestational age at delivery
- After 30 weeks in those who met the primary outcome of pre-eclampsia
Neonatal survival to hospital discharge
- Neonatal survival to hospital discharge
- 93%
Safety
Serious infections
- No serious infections
New cases or severe flares of lupus
- No new cases or severe flares of lupus
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Certolizumab pegol to prevent adverse pregnancy outcomes in patients with antiphospholipid syndrome and lupus anticoagulant (IMPACT): results of a prospective, single-arm, open-label, phase 2 trial. Ann Rheum Dis. Published 10 April 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →