You are here
Overall outcomes of pregnancy among women with inactive or minimally active systemic lupus erythematosus (SLE) were "highly favorable," but certain baseline factors predicted adverse outcomes, the largest prospective study of SLE pregnancy found.
Among 385 women enrolled in a study known as PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody pSyndrome and Systemic Lupus Erythematosus), the rate of uncomplicated pregnancy was 81%, according to Jill P. Buyon, MD, director of the division of rheumatology and the Lupus Center at NYU Langone Medical Center in New York City, and colleagues.
Four baseline characteristics were predictive of an adverse outcome occurring at any time during pregnancy, Buyon and colleagues reported online in Annals of Internal Medicine:
·Lupus anticoagulant positivity: OR 8.32 (95% CI 3.59-19.26, P<0.001)
·Current use of antihypertensive medication: OR 7.05 (95% CI 3.05-16.31, P<0.001)
·Physician's global assessment score higher than 1: OR 4.02 (95% CI 1.84-8.82, P<0.001)
·Low platelet count: OR 1.33 (95% CI 1.09-1.63, P=0.006)
"This study solidifies that, for many women who are in remission or have minimal disease activity, pregnancy is not going to make their disease worse and they can have healthy babies," Buyon told MedPage Today.
"But it also acknowledges, and even more importantly perhaps, that there are factors that can be identified which really help in pregnancy counseling," she said.
The current advice on childbearing for women with SLE suggests that pregnancy can be considered when disease is inactive or minimally active, but that recommendation is based largely on small, retrospective, or single-center studies.
Therefore, to provide more reliable data for patients and physicians, the researchers enrolled pregnant patients from nine North American centers from September 2003 to December 2012.
"PROMISSE is the largest multicenter, multiethnic, and multiracial study to prospectively assess the frequency of [adverse pregnancy outcomes], clinical and laboratory variables that predict them, and pregnancy-associated flare rates in women with inactive SLE or mild or moderate SLE activity at conception," they wrote.
Disease activity was assessed on the Systemic Lupus Erythematosus Pregnancy Disease Activity Index (SLEPDAI), and flares were evaluated on a composite measure that incorporated the SLEPDAI, changes in disease activity and medication, physician's global assessment, and hospitalizations.
The cohort was 48% non-Hispanic white, and 35% were either African-American or Hispanic.
Mean baseline SLEPDAI score was 2.8, and mean physician global score was 0.39. In more than 90%, urinary protein excretion was below 500 mg/day.
A total of 19% of women experienced at least one adverse pregnancy outcome, including fetal death in 4%, neonatal death in 1%, preterm delivery in 9%, and small for gestational age in 10%.
Among SLE patients who were positive for antiphospholipid antibodies, 43.8% (95% CI 29.5-58.8) had an adverse outcome compared with 15.4% (95% CI 11.7-19.7) of patients without the antibodies, and 3% (95% CI 1.1-6.4) of control non-SLE women.
On bivariate analyses, women who had adverse pregnancy outcomes more often were African-American and obese, had previously had renal disease or thrombosis, and had experienced a previous fetal loss.
They also were more likely to be lupus anticoagulant positive and to have low complement or platelet counts.
At weeks 20 to 23, 12.7% of women had a mild or moderate flare and 2.5% had a severe flare, while at weeks 32 to 35, the corresponding rates were 9.6% and 3%. These rates were very low,according to Buyon.
The most common flare manifestations were nephritis, pleuritis, and arthritis.
On multivariable analysis in the model considering risk of adverse outcome at any time during pregnancy, non-Hispanic white ethnicity was associated with a decreased risk (OR 0.45, 95% CI 0.24-0.84, P=0.013).
In a second model that estimated risk after week 23, the same four baseline characteristics were associated with risk as in the initial model of risk at any time in pregnancy, but the greatest risk was for current antihypertensive use (OR 13.14, 95% CI 4.79-36.04, P<0.001), Buyon and colleagues reported.
And in a third model of risk after week 35, antihypertensive use again was the strongest associated factor (OR 7.69, 95% CI 2.37-24.96, P<0.001).
A total of 129 women had none of the major risk factors -- they were not using antihypertensive medication, were negative for lupus anticoagulant, had an adequate platelet count, and had a physician's global assessment score of 1 or less. Only 10 of these women had an adverse outcome at any time (7.8%, 95% CI 3.8-13.8), and the fetal/neonatal mortality rate was 3.9% (95% CI 1.3-8.8).
In contrast, among those who were Hispanic or nonwhite and were on antihypertensives, adverse outcomes were seen in 58% (95% CI 43.2-71.8) and the fetal/neonatal mortality rate was 22% (95% CI 11.5-36).
The principal investigator of PROMISSE, Jane E. Salmon, MD, director of the Lupus and APS Center of Excellence and Collette Kean Research Chair at the Hospital for Special Surgery in New York City, pointed out another important contribution of the study.
"The ability to anticipate complications and to identify those rare patients who will have serious pregnancy problems early in the course of their pregnancy will enable us to develop interventional trials to prevent these complications. Such trials have never been considered before," she told MedPage Today.
A limitation of the study was the exclusion of women with high disease activity and those with first-trimester pregnancy loss.
The study was funded by the NIH.
Buyon and co-authors disclosed no relevant relationships with industry.
Salmon disclosed support from the the Mary Kirkland Center for Lupus Research and Rheuminations. One co-author disclosed support from the NIH.
This piece by Nancy Walsh, Senior Staff Writer, is brought to RheumNow readers by our friends at MedPage Today, where it originally appeared on June 23, 2015.