Biomarkers Identify Pregnant Women with Lupus or APL at Risk for Adverse Outcomes

high-risk patients early in pregnancy.

"Given that over 20% of pregnant women with lupus APL experience adverse pregnancy outcomes, the ability to identify patients early in pregnancy, who are destined for poor outcomes, would significantly impact care," said lead investigator Jane E. Salmon, MD, Weill Cornell Medical College (New York City, NY, USA).

The investigators used data and samples from the PROMISSE Study, where 497 pregnant patients with SLE and/or APL were enrolled at <12 weeks gestation between September 2003 and August 2013 at seven sites, along with 207 matched healthy controls, and were followed every month of pregnancy. They found that maternal-blood biomarkers, specifically – circulating angiogenic factors that regulate development of the placenta and influence the health of blood vessels in the mother, can be assessed early in pregnancy. As early as 12-15 weeks into pregnancy, changes in these biomarkers can signal an increased risk for severe complications.

The researchers also found that measuring these biomarkers had a high negative predictive value, therefore severe complications could be ruled out in most patients. "Timely risk stratification of patients is important for effective clinical care and optimal allocation of healthcare resources," said Dr. Salmon. Without good predictive tests, most of these patients undergo extensive antenatal evaluation, including serial obstetrical ultrasound exams and multiple visits to rheumatologists and obstetricians. With good predictive tests, the majority would be identified as being at low risk and the number of their medical visits and healthcare costs could be substantially reduced. Those at high risk would be managed by specialists with close monitoring and delivery.

"Pregnancies in patients with SLE and/or APL can result in poor outcomes even when disease activity is low, and baseline clinical features and laboratory tests have only modest ability to identify patients at highest risk," said Dr. Salmon, "Our study is the first to demonstrate, in a prospective cohort, the usefulness of angiogenic biomarkers measured as early as the 12th week of pregnancy, in combination with clinical criteria, to identify patients with SLE and/or APL at risk of severe adverse pregnancy outcomes."

The study, by Kim MY et al, was published online ahead of print September 28, 2015, in the American Journal of Obstetrics & Gynecology.

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