Pregnancy Safe in Women With Stable Lupus

Debra Gordon, MS

November 09, 2011

November 9, 2011 (Chicago, Illinois) — Women with stable lupus erythematosus have a far lower rate of serious complications during pregnancy than previously reported, even those with a history of lupus nephritis, according to data presented here at the American College of Rheumatology 2011 Annual Meeting.

The PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) trial is a large multicenter study designed to identify biomarkers that can predict adverse outcomes in pregnant women with lupus. To date, nearly 700 women have enrolled. PROMISSE has 4 groups: those with lupus only, those with lupus and antiphospholipid syndrome, those with antiphospholipid syndrome only, and healthy women who have had at least 1 uncomplicated pregnancy and delivery.

All 333 pregnant women in the multiethnic cohort enrolled before their second trimester and were seen by a rheumatologist every trimester. One third of the women had a history of lupus nephritis; half had anti-DNA autoantibodies; 11% had antiphospholipid antibodies; and one fifth had low complement levels — all indicators of serious disease. In addition, 40% were receiving steroid therapy (less than 20 mg/day).

The overall complication rate in women with lupus was 19%, compared with about 5% in healthy women; in the general population, the complication rate is about 10%. Complications were defined as fetal death (4.5% in the lupus group; 2% in the general population); neonatal death (1.2% and 1.0% ); preterm birth before 36 weeks (9.1% and 3.0% to 4.0%); small for gestational age (9.1% and about 6.0%); and preeclampsia (10.3% and 4.0% to 5.0%).

Other studies have demonstrated complication rates as high as 30% in women with lupus, noted investigator Jane Salmon, MD, from the Hospital for Special Surgery in New York City. However, those studies used a far broader definition of "adverse effects," she said.

The "extraordinary news," said first author and presenter Jill Buyon, MD, from New York University Medical Center, in New York City, is that just 15 patients (4%) had a severe flare during their pregnancy, and just 18% experienced a mild to moderate flare, most of which resolved without steroids.

Risk factors associated with poor outcome include slightly higher baseline disease activity (measured by clinical instruments and physician global assessment), the presence of lupus anticoagulant antibodies, slightly higher uric acid in the second and third trimesters, and a smaller complement increase as the pregnancy progresses.

A multivariate analysis identified history of renal disease as an independent predictor of complications, said Dr. Buyon.

"What the study says is that even patients with a history of lupus nephritis can do well during pregnancy," she said, assuming they become pregnant when their disease is stable and they are managed by maternal–fetal medicine specialists who specialize in high-risk pregnancies. "That's a really encouraging message to give these women."

S. Sam Kim, MD, associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia, said most rheumatologists are "nervous" and "scared" about women with lupus becoming pregnant.

"I think this study is vitally needed," he said. "It gives us some more reassurance and direction. Any guidance we can have in terms of reproductive issues is extremely important in the field of lupus and the people we treat."

Eric L. Matteson, MD, chair of the Department of Rheumatology at the Mayo Clinic in Rochester, Minnesota, said the results have the potential to change clinical practice.

"I know there's quite a marked reluctance on the part of many practitioners, particularly those who don't see many lupus patients," to support pregnancy in lupus patients. This study, he said, "is a cause for optimism. By and large, the patients will do well and their pregnancy will be successful, even if they have serologic evidence of active disease."

Dr. Salmon, Dr. Buyon, Dr. Kim, and Dr. Matteson have disclosed no relevant financial relationships.

American College of Rheumatology (ACR) 2011 Annual Meeting: Abstract 1707. Presented November 7, 2011.

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