Certolizumab Pegol Reduces Adverse Pregnancy Outcomes in High-Risk APS Patients
A prospective study published in Annals of the Rheumatic Diseases has shown that certolizumab pegol, when added to standard therapy with low molecular weight heparin and low-dose aspirin, significantly reduces adverse pregnancy outcomes (APO) in high-risk pregnancies among patients with antiphospholipid syndrome (APS).
These findings suggest certolizumab may offer a protective role in pregnancies complicated by lupus anticoagulant positivity and a high risk of placental insufficiency.
The study enrolled 51 pregnant patients with APS and lupus anticoagulant. Certolizumab, a TNF-α inhibitor with minimal placental transfer, was administered from gestational weeks 8 to 28 alongside standard care. The primary composite outcome included fetal death at or beyond 10 weeks’ gestation, pre-eclampsia with severe features, or placental insufficiency requiring delivery before 34 weeks.
Among the 45 evaluable patients (excluding early pregnancy losses and genetically related fetal deaths), 9 experienced a primary APO, yielding an incidence of 20% (95% CI, 9.6%–34.6%). This rate met the study’s predefined efficacy threshold was "and significantly lower than rates in historical controls,” the authors reported.
Median gestational age at delivery among certolizumab-treated patients was 36.5 weeks. Importantly, among those who did meet APO criteria—primarily due to pre-eclampsia—deliveries occurred after 30 weeks, suggesting a reduction in extreme prematurity. Neonatal survival to hospital discharge was 93%.
The treatment was well tolerated, with no reported serious infections, new cases of lupus, or severe disease flares during the treatment period, the authors noted, underscoring the drug’s safety profile in this vulnerable population.
“Certolizumab appears effective in preventing placenta-mediated adverse outcomes in high-risk patients with APS,” the study concluded.
For rheumatologists managing patients with APS who are planning pregnancy or are already pregnant, these findings highlight the potential of certolizumab to reduce APO risk beyond standard anticoagulation and antiplatelet therapy. The results support further investigation of TNF-α inhibition as a strategy to improve maternal and neonatal outcomes in this high-risk cohort.
Reference
Branch DW, Kim MY, Guerra MM, et al. 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. 2025;84(6):1011-1022. doi:10.1016/j.ard.2025.02.012
