The PROMISSE Study: The Nation's Largest Ever Investigation of Pregnancy Loss in Lupus

Jane Salmon, MD, and her team rewrote the knowledge banks about pregnancy loss in women with lupus when they established that the complement system - not widely believed thrombosis - was the cause. And now, with the PROMISSE Study, Dr. Salmon intends to change the field even more

The PROMISSE Study is a ten-year, multi-center project funded by the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health. "In the PROMISSE Study, we are collecting data, prospectively, from 700 women and assessing activity of inflammatory and immune pathways throughout their pregnancies," explains Dr. Salmon. "Our goal is to find new ways to predict outcomes and new targets for treatment."

PROMISSE stands for Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid antibody Syndrome and Systemic lupus Erythematosus. Seven hundred pregnant volunteer patients with lupus and/or antiphospholipid antibodies, as well as disease-free subjects, will be closely monitored every month of their pregnancy. 

Dr. Salmon, an HSS Attending Rheumatologist, Senior Scientist, and Collette Kean Research Chair, heads the PROMISSE Study. This nationwide investigation grew from her team’s ground-breaking discoveries about the causes of the prevalence of premature pregnancy loss in women with lupus and antiphospholipid antibodies.

The Discovery That Changed it All

Before 2001, thrombosis was widely assumed to be the cause of miscarriages in women with antiphospholipid antibodies and lupus. Preventing thrombosis was standard procedure. Yet, that treatment - anticoagulation throughout pregnancy - was risky, unreliable, and did not consistently result in more successful pregnancies.

Then Dr. Salmon and her team discovered why: thrombosis, in and of itself, wasn’t responsible for pregnancy loss. The real culprit was the complement system. Since that landmark finding, Dr. Salmon and her lab have shown in experiments in animal models that inhibiting complement system activity in vivo can prevent fetal loss and growth restriction associated with antiphospholipid antibodies.

Early Findings Already Helping

Over 590 patients have already been enrolled in the PROMISSE Study. First studies show timing of conception with regard to lupus activity affects outcomes. Conception when the disease is inactive is associated with rare flares during pregnancy and improved likelihood of delivering healthy babies. Also, the presence of lupus anticoagulant  - a specific subset of antiphospholipid autoantibodies - is highly associated with poor pregnancy outcome, while anticardiolipin antibodies, alone, are not strong predictors of pregnancy complications. [More findings and scientific details can be found in the Special Report in the upper right column of this page.]

"Women with lupus can have normal pregnancies when they work together with their doctors," reports Dr. Salmon. "First, they can time conception when flares are not present. Then they can maintain continual, close follow-up to anticipate potential problems."

With such a large, carefully-studied patient population, the PROMISSE Study is well poised to achieve its ultimate goal: uncover therapeutic targets and establish treatment strategies that will help women with lupus and antiphospholipid antibodies deliver healthy babies.

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