Dr. Jane Salmon, Professor of Medicine in the Weill Department of Medicine and Collette Kean Research Chair at Hospital for Special Surgery, has published a pivotal paper, "Predictors of Pregnancy Outcomes in Patients with Lupus – A Cohort Study," in the Annals of Internal Medicine. In this multicenter study, Dr. Salmon and colleagues identified clinical and laboratory predictors of adverse pregnancy outcomes in women who have inactive or stable-mild active lupus.
Pregnancy is a major concern for women with systemic lupus erythematosus (SLE), a disease that typically present in childbearing years. In the past, it was recommended that women with lupus avoid pregnancy because of serious potential complications to their health and the health of the baby. Pregnancies in women with SLE are at increased risk of preterm births, pre-eclampsia, and fetal demise (compared to pregnancies in healthy women), but which patients would suffer adverse pregnancy outcomes could not be predicted. To provide advice and guidance, physicians require clinical and laboratory parameters that are specific and predictive. Previous studies on SLE and pregnancy have been retrospective, small, single-center, and therefore limited in scope.
To obtain robust data for their study (published online June 23, 2015) the researchers leveraged a study known as PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus). PROMISSE is the largest multicenter, multi-ethnic, and multi-racial study to prospectively assess the frequency of adverse pregnancy outcomes, clinical and laboratory variables that predict complications, and frequency of pregnancy-associated flare rates in women with inactive SLE or mild or moderate SLE activity at conception. The study followed 385 SLE patients monthly through their pregnancies and included eight centers in the U.S. and one center in Canada.
In PROMISSE, Dr. Salmon and her colleagues found that 81% of women experienced pregnancy outcomes that were good while, 5% ended in death of the fetus or newborn. Flares of lupus activity were very rare, and, importantly, severe flares occurred in only 3 percent of women. The study identified several baseline features to be associated with risk of adverse pregnancy outcomes (in descending order): presence of a lupus anticoagulant; hypertension requiring treatment at baseline; higher lupus disease activity at baseline; and low platelet count. In addition, the frequency of poor outcomes in African and Hispanic Americans was greater than that in non-Hispanic white women. Absent specific risk factors, outcomes were favorable.
The findings from the PROMISSE study provide important data for physicians who treat reproductive-age women with SLE. Patients should be counseled to plan their pregnancies when their disease is inactive. Although SLE pregnancies should be managed by rheumatologists and high-risk pregnancy obstetricians, patients with no identified risk factors can be reassured. SLE patients with one or more risk factors must be closely monitored and, in the future, may be considered for innovative interventional trials to prevent pregnancy morbidity and mortality.
Dr. Salmon said, "Lupus patients and their doctors can be confident of a good pregnancy outcome in most cases if lupus is quiescent when they become pregnant, and that severe flares during pregnancy will be infrequent. In addition, our findings allow clinicians to identify the patients at high risk who require much closer follow-up."