Certolizumab pegol, a TNF-α inhibitor with minimal placental transfer, was added to standard anticoagulation in pregnant patients with antiphospholipid syndrome (APS) and lupus anticoagulant (LA).
The IMPACT phase 2 open-label trial showed a reduction in adverse pregnancy outcomes (APO), including fetal death ≥10 weeks, severe pre-eclampsia, and placental insufficiency necessitating early delivery.
Primary APO rate was 20% with certolizumab, significantly lower than 40% observed in historical controls receiving standard care.
The treatment was well tolerated without serious infections or worsening lupus activity, and neonatal survival to hospital discharge was 93%.
