PROMISSE study: Most women with lupus can expect good pregnancy outcomes

One of the most important and anxiety-producing concerns among patients with lupus is whether it is safe to become pregnant. A pioneering study led by researchers at Hospital for Special Surgery (HSS) has shown that most women can expect a good pregnancy outcome if their lupus is inactive and they are free of certain risk factors.

The findings, published in the Annals of Internal Medicine, are the culmination of a 10-year prospective, multi-center study known as PROMISSE (Predictors of Pregnancy Outcome: bioMarkers In antiphospholipid antibody Syndrome and Systemic lupus Erythematosus) led by researchers at Hospital for Special Surgery. PROMISSE, funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, was launched in 2003 to identify risk factors that predict poor pregnancy outcomes in women with lupus and antiphospholipid antibody syndrome. Jane E. Salmon, M.D., Director of the Lupus and APS Center of Excellence and Collette Kean Research Chair at Hospital for Special Surgery, was the principal investigator of the study and led the team of clinicians and researchers.

Systemic lupus erythematosus, commonly known as lupus, primarily affects women of childbearing age. It is an autoimmune disease in which the body's immune system mistakenly attacks and damages healthy tissue. It can affect the skin, joints, kidneys, brain and other organs. In the past, lupus patients were advised not to become pregnant because of potential risks to their health and that of their baby.

'Our findings provide a clear direction for counseling patients, and reassuring women with inactive lupus,' said Dr. Salmon, principal investigator. 'We also learned that patients with specific clinical features and certain antibodies that can be detected early in pregnancy by blood tests have an increased risk of serious pregnancy complications.'

Researchers followed 385 pregnant women enrolled between September 2003 and December 2012 at eight sites in the United States and Canada. PROMISSE is a multi-ethnic, multi-racial study, and the largest prospective study of lupus pregnancies. All women were enrolled in the first 12 weeks of their pregnancies and had inactive or stable mild to moderate lupus disease activity at the time of enrollment. They were seen by study investigators monthly.

Study results

Investigators reported that 81 percent of pregnancies were free of complications. Fetal or neonatal death occurred in 5 percent of pregnancies. Nine percent of women had a preterm delivery. Ten percent of babies had a low birth weight. Most patients with these pregnancy complications had one or more risk factors: a specific antiphospholipid antibody in the blood, a history of hypertension, and/or a low platelet count.

'It was exciting to see that severe lupus flares occurred in less than three percent of women during pregnancy,' said Dr. Salmon. 'Lupus patients and their doctors can be confident of a good pregnancy outcome in most cases if lupus is quiescent when they become pregnant. Our findings now allow clinicians to identify the patients at high risk and manage them accordingly.'