WASHINGTON, March 31, 2021 /PRNewswire/ -- The Lupus Foundation of America is pleased to announce a new three-year grant, funded by the Festa Family Foundation, supporting the IMPACT study (IMprove Pregnancy in APS with Certolizumab Therapy), the first trial of a biologic therapy to prevent adverse pregnancy outcomes in high-risk pregnancies in patients with antiphospholipid syndrome (APS) with or without systemic lupus erythematosus (SLE). The lead investigator of the study is Jane Salmon, MD, Collette Kean Research Professor at Hospital for Special Surgery.
Nine out of 10 people with lupus are women and the disease typically develops during childbearing years, which can make reproductive health an important topic for many women with lupus. A specific autoantibody (lupus anticoagulant, LAC, a type of APS), which can be detected in the blood in the first trimester, is linked to a 10-fold increase in risk of complications. Treatments are desperately needed for women around the world living with lupus and APS who are at risk of pre-term birth, poor placental development and preeclampsia. These complications, which can also lead to inadequate nutrition and oxygenation of the developing fetus, can cause 10-20% of pregnant women with SLE to deliver at 24-28 weeks.
If successful, the IMPACT study has the potential to provide a new approach to protecting pregnancies for people with lupus and countless other women at risk for these complications. The treatment being studied, certolizumab which blocks TNFα – a key inflammatory mediator in inflamed placenta, is being evaluated and has the potential to be the first biologic that may help prevent these pregnancy complications, enabling women to deliver healthy, full-term babies.
"Pregnancy is particularly stressful for women living with lupus. When I talk to a lupus patient, the first thing she'll often ask is – can I have a child? And, as a mother myself, I have been passionate about making sure that all women with lupus can have the joy of motherhood if they so desire," shared lead trial investigator Dr. Salmon. "Women with lupus are at higher risk for complications including preeclampsia, growth restricted babies and fetal death, which are manifestations of placental failure. And, currently, we don't have good approaches to prevent these poor outcomes. With the support from the Lupus Foundation of America for our IMPACT study, we are conducting the first trial with a biologic therapy to prevent these pregnancy complications and hope to expand our understanding of why complications occur so people living with lupus can have safe, successful pregnancies."
Dr. Salmon is also a Professor of Medicine in Obstetrics and Gynecology and Associate Dean, Faculty Affairs at Weill Cornell College of Medicine. At the Hospital for Special Surgery she is also a Director of the Lupus and APS Center of Excellence and Co-Director of the Mary Kirkland Center for Lupus Research. For over 20 years, her laboratory has focused on the mechanisms by which placental injury occurs in people with lupus.
"The Lupus Foundation of America is committed to funding research that addresses unmet treatment needs and with the greatest potential impact to improve the lives of people living with lupus," said Stevan W. Gibson, president and CEO, Lupus Foundation of America. "While there has been tremendous progress in making pregnancy for people with lupus safer, there is still a high risk of complications for many women and no current treatments. Because of the critical need to develop a treatment that can improve pregnancy outcomes, the Foundation took the important step to dedicate funding to the groundbreaking work of the IMPACT study. This crucial research has the promise to build a better future in which women with lupus and others with high-risk pregnancies can fulfill their dreams of motherhood."
About the Lupus Foundation of America The Lupus Foundation of America is the national force devoted to solving the mystery of lupus, one of the world's cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact. Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus. Learn more about the Lupus Foundation of America at lupus.org.