Promising research led by investigators at Hospital for Special Surgery may offer hope for women with lupus who once thought that pregnancy was too risky.
Results from the multicenter National Institutes of Health (NIH) funded PROMISSE initiative, being presented Nov. 7 and then during a press conference on Nov. 8, during the American College of Rheumatology's 2011 Annual Scientific Meeting in Chicago, show that most women with stable lupus can have successful pregnancies.
"There was a misconception, based on outdated experience, that women with lupus should not try to have children," said Jane Salmon, M.D., the study's senior author and Collette Kean Research Chair at Hospital for Special Surgery in New York City. "Now that our treatments are more effective and we have a better understanding of the disease, we can identify a window when pregnancy is safe and outcomes are good for mother and fetus."
Historically, women with systemic lupus erythematosus (also know as SLE or lupus) have been advised not to become pregnant because of risks to their own and their fetus' health. SLE is a chronic inflammatory disease, in which the body's own immune system attacks tissues of the body and can cause complications during pregnancy.
Dr. Salmon, together with Dr. Jill Buyon from New York University Medical Center, and their collaborators evaluated 333 pregnant women with lupus from the PROMISSE Study (Predictors of pRegnancy Outcome: BioMarkers In antiphospholipid antibody Syndrome and Systemic Lupus Erythematosus), which seeks to identify biomarkers that predict poor pregnancy outcomes. The research team found that 80 percent of lupus patients had a favorable pregnancy outcome.
Patients with lupus may be free of symptoms for long periods of time and then experience a disease "flare," when symptoms such as rash, joint pain, chest pain, swollen legs, bruising and/or fatigue suddenly appear.
"Most women with stable lupus, defined as limited disease activity and no flares during the time of conception and the first trimester, had successful pregnancies," explained Dr. Salmon, who is also the principal investigator of the PROMISSE Study. "We learn from these results that timing is a most important element for successful pregnancy in women with lupus and that avoiding pregnancy during periods of increased disease activity is essential."
In the study, two categories of pregnancy complications were evaluated: the health of the mother and of the fetus. The research team studied development of mild, moderate, or severe increases of lupus activity, or flares, in expectant mothers. For the fetus, the study examined the worst outcome -- death -- or situations in which the well being of the child would require extended hospitalization in a critical care unit.
Of the 333 women with lupus studied, 63 had poor outcomes. Ten percent of mothers experienced preeclampsia, a serious complication characterized by the onset of high blood pressure and appearance of protein in the urine. Ten percent experienced mild or moderate flares at 20 weeks and eight percent experienced flares at 32 weeks. Nineteen women experienced death of the fetus and 30 women delivered before 36 weeks or had newborns of small gestational size -- smaller in size than normal for the baby's sex and gestational age, commonly defined as a weight below the 10th percentile for gestational age.
None of the women in the study was pregnant with more than one fetus, took more than 20 mg/d of prednisone, or had abnormally high excretion of protein or impaired kidney function. The women who experienced complications had more active lupus at 20 and 32 weeks and higher levels of antiphospholipid antibodies.
The PROMISSE study was funded by the National Institute of Arthritis, Musculoskeletal and Skin Diseases of the National Institutes of Health in 2003 to identify biomarkers that would predict poor pregnancy outcomes in lupus patients. To date, the PROMISSE investigative team has enrolled 647 volunteers who are monitored with monthly checkups and research laboratory studies looking at genes and circulating proteins that may predict the course of pregnancy. PROMISSE will continue through 2013 with $12.3 million in support over ten years from NIAMS and the office of Research in Women's Health. Dr. Salmon and co-investigators from 11 academic centers will continue to examine a broad range of genes and molecular pathways that can affect pregnancy in women with lupus, and, it is anticipated that their findings will have applications for the prevention of miscarriage and preeclampsia in healthy women.
The PROMISSE Study is coordinated by Dr. Salmon; Other investigators include Michael Lockshin, M.D., and Lisa Sammaritano, M.D., at Hospital for Special Surgery; Jill Buyon, M.D., at New York University School of Medicine; Ware Branch, M.D., at University of Utah Health Sciences Center; Carl Laskin, M.D., at Mt. Sinai Hospital in Toronto, Canada; Joan Merrill, M.D., at the Oklahoma Medical Research Foundation; Michelle Petri, M.D., MPH, at Johns Hopkins University School of Medicine; Mimi Kim, D.Sc., at Albert Einstein College of Medicine; and Mary Stephenson, M.D., at the University of Chicago.
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