A small but striking trial is reshaping how we think about high-risk pregnancies in women with antiphospholipid syndrome (APS) and lupus. The IMPACT trial found that adding certolizumab pegol — a TNF-alpha inhibitor that doesn't cross the placenta — to standard therapy cut adverse pregnancy outcomes by more than 50% compared to historical controls. The drug recently received FDA Breakthrough Therapy Designation, signaling a potential new standard of care.
A small but striking trial is reshaping how we think about high-risk pregnancies in women with antiphospholipid syndrome (APS) and lupus. The IMPACT trial found that adding certolizumab pegol — a TNF-alpha inhibitor that doesn't cross the placenta — to standard therapy (low-molecular-weight heparin + low-dose aspirin) cut adverse pregnancy outcomes (APOs) by more than 50% compared to historical controls. The drug recently received FDA Breakthrough Therapy Designation for preventing placenta-mediated APOs in pregnant women with APS who are positive for lupus anticoagulant.
Presented at PRD 2026, updated results now include 55 patients, with 95% of pregnancies resulting in a live birth surviving to hospital discharge. Experts say the findings point to inflammation — not just clotting — as a key driver of pregnancy loss in these patients, opening the door to a new therapeutic target.
By the Numbers:
Why it matters: For women with APS and lupus, pregnancy can be devastating — the Lupus Foundation of America notes a 10-fold increase in pregnancy complication risk. If confirmed in larger trials, certolizumab could become the first biologic approved to prevent pregnancy complications in this population, fundamentally changing the standard of care.
