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Breakthrough Therapy Designation to Cimzia for Antiphospholipid Syndrome
Monday, 19 October, 2026
Jane Salmon, MD, Professor of Medicine at Weill Cornell Medical College, discusses antiphospholipid syndrome (APS), its impact on pregnancy, and emerging research into Cimzia (certolizumab pegol) as a potential approach to preventing serious pregnancy complications. APS is an autoimmune condition characterized by an increased risk of thrombosis and serious pregnancy complications (e.g., preeclampsia, placental insufficiency, growth restriction, intrauterine fetal death, and recurrent early miscarriages). Thrombosis may also cause severe, life-threatening complications such as stroke. Diagnosis involves testing for three types of antibodies: anti-cardiolipin, anti-beta 2 GP1, and the lupus anticoagulant, with the latter carrying the highest risk for thrombosis and pregnancy complications. Despite the significant burden of the condition, there are currently no FDA-approved therapies and patients are typically managed with low-dose aspirin and heparin.The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to certolizumab pegol for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have APS and are positive for lupus anticoagulant. Certolizumab pegol is a tumor necrosis factor (TNF) blocker currently indicated for a variety of autoimmune conditions.Breakthrough Therapy Designation is granted to treatments intended to address serious or life-threatening conditions when preliminary clinical evidence indicates the therapy may demonstrate substantial improvement over available treatments on one or more clinically significant endpoints. The designation is designed to facilitate development and expedite the FDA review of promising new therapies. The designation for certolizumab pegol is supported by preliminary clinical evidence from the IMPACT clinical trial (NCT03152058).The trial met its primary endpoint, reducing the adverse outcome rate to 20% in the study population, compared to a 44% historical adverse outcome rate. Furthermore, 95% of the women in the trial had live-born babies who survived to hospital discharge, marking a significant improvement over the 37% rate observed in the participants' previous pregnancies. Although the intervention did not completely eliminate adverse outcomes, it made them significantly less severe by allowing for later gestational ages at the time of delivery.For more information, visit https://www.prnewswire.com/news-releases/ucb-receives-us-fda-breakthrough-therapy-designation-for-cimziacertolizumab-pegol-in-pregnant-women-with-antiphospholipid-syndrome-aps-302873706.htmlTo learn more about rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-autoinflammatory-disorders/Rare Discussions is produced by CheckRare, the leading multimedia platform dedicated to advancing education, awareness, and innovation across the rare disease community.Explore additional physician interviews, podcasts, CME activities, and rare disease resources at CheckRare.com.Subscribe to the CheckRare Podcast Network for expert conversations, weekly news, accredited education, and the latest advances across the rare disease community.Part of the CheckRare Podcast Network: Trusted conversations, news, education, and expert insights across the rare disease community.
