1. From a prospective cohort study, adverse pregnancy outcomes in lupus patients were associated with the presence of lupus anticoagulant, antihypertensive use, and a higher Physician’s Global Assessment score.
2. Absent these risk factors, adverse pregnancy outcomes occurred rarely in patients with stable mild or moderate lupus.
Evidence Rating Level: 2 (Good)
Study Rundown: Systemic lupus erythematosus (SLE) predominantly affects women of childbearing age, and while it does not affect a woman’s fertility, it can affect the outcome of pregnancy. In this cohort study, the rate of adverse pregnancy outcomes (APOs) was determined in women with inactive, mild or moderate SLE versus similarly pregnant women without SLE. At least one APO occurred in 19% of trial participants with SLE. Observed APOs included fetal death, neonatal death, preterm delivery and small-for-gestational-age (SGA) neonate. Baseline risk factors for APOs included lupus anticoagulant (LAC) positivity, antihypertensive medication use, Physicians’ Global Assessment (PGA) score greater than 1, and a low platelet count. SLE flares during the second and third trimester also increased risk of having an APO. Non-Hispanic white ethnicity was also associated with a lower risk for APOs compared with all other ethnic/race groups. This study was limited in that it did not include APOs suffered during the first trimester and it did not include women with high SLE disease activity. Overall, this study demonstrated that, in the absence of identified baseline risk factors, pregnancy outcomes may be favorable for women with SLE.
In-Depth [prospective cohort]: This study followed participants in the Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE) study—a multicenter, prospective observational study. There were 385 patients with SLE recruited up to 12 weeks’ gestation from 9 different sites included in the study, with only 4 lost to follow-up. At least one APO occurred in 19% (CI 15.2% to 23.2%) of women with SLE compared to 3% (CI 1.1% to 6.4%) of women without SLE. APO rates in women with SLE included 4% fetal death, 1% neonatal death, 9% preterm delivery, and 10% SGA neonate. The rate of APOs in women with SLE and anti-phospholipid antibodies was 43.8% (CI 29.5% to 58.8%) compared to 15.4% (CI 11.7% to 19.7%) in women with SLE. Out of 129 non-Hispanic white patients with none of the identified baseline risk factors (LAC-positivity, antihypertensive medication, PGA score >1, and low platelet count), only 10 (7.8%; CI 3.8% to 13.8%) had an APO.
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