New York, NY—September 29, 2015
Researchers at Hospital for Special Surgery (HSS) have released a second set of results from the PROMISSE study showing that angiogenic biomarkers measured in maternal blood successfully predict whether or not a woman with lupus is likely to experience serious complications during pregnancy – complications that could negatively affect her health or that of her baby.
The new findings from the study, also known as "Predictors of pRegnacy Outcome: BioMarkers in antiphospholipid antibody Syndrome and System lupus Erthematosus" were published in The American Journal of Obstetrics and Gynecology.
PROMISSE showed that 20 percent of women with systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL) syndrome who become pregnant are at increased risk for adverse outcomes. Both conditions, by themselves and together, can lead to fetal death, miscarriages, growth-restricted babies and/or preeclampsia, a condition of severe high blood pressure and kidney problems during pregnancy. The capacity to identify, early in pregnancy, those women at risk for serious complications and those likely to have normal pregnancies will allow for more personalized care.
Doctors can more closely monitor high risk pregnancies, and they can reassure low-risk mothers that their pregnancies should progress smoothly. Doing so will reduce anxiety in parents-to-be and minimize the need for extensive medical evaluations, visits and cost associated with SLE and APL patient care during pregnancy.
In this study, researchers measured proteins made by the placenta that circulate in the mother’s blood, which also regulate growth and development of the placenta, called angiogenic factors. As early as 12 -15 weeks into a pregnancy, alterations in their levels identified pregnancies associated with a high risk for serious problems. Most importantly, normal levels predicted normal pregnancies. Angiogenic factor levels are biomarkers, predictors of outcomes that, when available in routine clinical laboratories, provide guidance for management of patients allowing physicians to make realistic predictions of outcome early enough to consider interventions.
"The findings of the study allow physicians to stratify risk early in pregnancy to optimize patient care and allocation of healthcare resources. If angiogenic biomarker levels remain normal, we can reassure patients that fewer than 5 out of 100 will not develop serious complications, such as preeclampsia, severe growth restriction or fetal death," said Jane E. Salmon, MD, Director of the Lupus and APS Center of Excellence and Collette Kean Research Chair at Hospital for Special Surgery and principal investigator of the PROMISSE study. "When these biomarker tests are available clinically, they will guide prenatal care in women living with lupus."
The new study revealed that only 12 percent of patients with inactive SLE and/or APL have severe adverse pregnancy outcomes, showing that most patients with these conditions go to term without difficulties. Those pregnancies defined as high risk, based on levels of angiogenic factors and clinical features, like high blood pressure and certain autoantibodies, had a 94 percent risk of preeclampsia before 34 weeks, delivery before 30 weeks or fetal death, compared to 4.6 percent with these serious complications in women with normal angiogenic factor levels and no clinical risk factors.
"The goal of our research efforts is to provide early identification of risk in expectant mothers with lupus and to develop treatments to prevent serious pregnancy complications," said Dr. Salmon. "We are halfway there, and now we are planning a trial with a drug that targets the mediators of placental injury in high risk women with SLE and APL."
Research reported in this press release was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number R01AR049772 and RO1AR43727 and by the Mary Kirkland Center for Lupus Research. PROMISSE is a multi-ethnic, multi-racial study, and the largest prospective study of lupus pregnancies. Between September 2003 and August 2013, PROMISSE enrolled 497 patients from eight sites in the United States and Canada. In June 2015, initial findings were released identifying clinical factors associated with poor pregnancy outcomes in women with inactive SLE and/or APL. The current study expands the work to biomarkers, further refining the capacity to risk stratify and personalize care.