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News|Videos|October 13, 2026
Jane E. Salmon, MD, on the IMPACT trial of certolizumab pegol for adverse pregnancy outcomes in APS
Author(s)Jane E. Salmon, MD
Fact checked by: Joshua Fitch, Senior Editor
Key Takeaways
- On September 9, 2026, certolizumab pegol received FDA Breakthrough Therapy Designation for preventing placenta-mediated adverse pregnancy outcomes in APS, based on the IMPACT trial.
- In the single-arm phase 2 trial, the primary composite adverse outcome occurred in 9 of 45 patients (20%; 95% CI, 9.6%–34.6%) with certolizumab added to heparin and aspirin.
On September 9, 2026, certolizumab pegol received FDA Breakthrough Therapy Designation for APS pregnancy; Jane E. Salmon, MD, reviews the IMPACT trial results behind it.
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On September 9, 2026, the FDA granted certolizumab pegol
Antiphospholipid syndrome is “a disease associated with pregnancy complications and thrombosis in both arteries and veins,” Salmon said, caused by antiphospholipid antibodies. Her focus is placenta-mediated obstetric complications: preeclampsia, placental insufficiency, fetal growth restriction, and fetal death.
Why IMPACT targeted inflammation
Standard treatment is anticoagulation with low-molecular-weight heparin and low-dose aspirin, but complications persist. “So, anticoagulation improves outcomes, but not adequately,” Salmon said. That gap drove the trial’s rationale: preclinical work implicated inflammation at the maternal-fetal interface, and certolizumab, a TNF inhibitor with minimal placental transfer, was chosen to target that pathway.
IMPACT trial results
In the single-arm, open-label phase 2 trial, certolizumab was added to heparin and aspirin from gestational weeks 8 through 28.1 The primary composite outcome, defined as fetal death at 10 or more weeks, preeclampsia with severe features, or placental insufficiency requiring delivery before 34 weeks, occurred in 9 of 45 patients (20%; 95% CI, 9.6%–34.6%).1
The median gestational age at delivery was 36.5 weeks, and neonatal survival to hospital discharge was 93%.1 No serious infections or new cases of lupus flare were reported.1
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
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