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  1. Women with Lupus Overwhelmingly Have Healthy Pregnancies By Whitney L. Jackson In contradiction to long-standing beliefs, a healthy pregnancy is possible for women who have lupus, says Jill Buyon, M.D., a rheumatologist and lupus specialist from New York University School of Medicine. “Patients with lupus have been under the impression that pregnancy would be a very dangerous thing for them. From the mother’s perspective, the concerns are: Will the mother sustain a lupus flare? For mothers who have once had kidney involvement: How safe is it to get pregnant? Will there be adverse pregnancy outcomes? Will the baby be very small? Will the baby be born so early that it needs to be in the hospital for a long time. And, of course, the scary question is: Will my baby die? These are the outcomes we look at from the perspective of counseling and what we wanted to learn from this study,” she said. Dr. Buyon recently published research in the Annals of Internal Medicine showing that women with relatively inactive lupus without serious flares experienced a normal pregnancy with a positive outcome. Study participants were women, ages 18-to-45, enrolled in the Predictors of Pregnancy Outcome: Biomarker in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE) Trial. The investigation was multi-center, multi-racial and multi-ethnic. Out of the 385 women followed during the study, 81 percent experienced no adverse events. Overall, 9 percent of pregnancies resulted in premature birth, 4 percent experienced pregnancy loss during the second or third trimester, 1 percent encountered infant death due to pregnancy complications, and 10 percent had very low birth weight. Throughout the study, investigators identified four factors that appeared to increase a woman's likelihood for a negative outcome — high blood pressure during pregnancy, more active lupus during gestation, low platelet count, and a positive lupus anticoagulant test during the first trimester. “The patients who tended to be more sick at the outset, tended to be those who might have an adverse pregnancy outcome. The highest risk factor is the presence of something called a lupus anticoagulant. The presence of this abnormal blood test is very important and one that absolutely all doctors should test for,” Dr. Buyon said. In addition, race and ethnicity — black, Hispanic and Asian — contributed to poor outcomes and was in and of itself, a risk factor. Dr. Buyon said she doubts it is due to socioeconomic factors because the patients were treated by similar doctors in tertiary care centers. She suspects it may be due to genetics, which needs to be explored. Although the findings point to the possibility of healthy pregnancies for this population, Dr. Buyon cautioned women who have high protein levels in urine due to uncontrolled kidney disease could still face significant problems with pregnancy. These women are typically advised to postpone pregnancy until their kidney disease improves. Ten to 15 percent of patients had a moderate flare requiring minimal medication changes, but less than 5 percent of patients had a flare that required high dose steroids or hospitalization. About one in five patients had a renal flare. “The other optimistic perspective was that 225 patients never had kidney disease, but many of them had anti DNA antibodies which is an antibody we worry about in developing renal disease. Only four people developed de novo renal disease. For people who had previous kidney disease ... but were in complete remission, they too had very few renal flares. I think this is very encouraging news for women with past renal disease who really are so worried that maybe they’ll never have a healthy pregnancy, that simply is not true (14:01),” Dr. Buyon said. The hope, she said, is that these findings can be used to inform discussions between doctors and their patients with lupus who are also interested in pursuing pregnancy. Dr. Buyon discusses the study, its findings and implications in the following video with Rheumatology Network. REFERENCES Jill P. Buyon, MD; Mimi Y. Kim, ScD; Marta M. Guerra, MS, et al. "Predictors of Pregnancy Outcomes in Patients With Lupus: A Cohort Study," Annals of Internal Medicine, Aug. 4, 2015. DOI: 10.7326/M14-2235 http://www.rheumatologynetwork.com/lupus/women-lupus-overwhelmingly-have-healthy-pregnancies?GUID=&rememberme=1&ts=12092017
  2. Most lupus pregnancies have good outcomes, study finds December 30, 2015 Women diagnosed with lupus may find the results of a new study reassuring, which suggests that most pregnancies among women with the condition have good outcomes if their lupus is inactive. The study also identifies certain risk factors associated with poor outcomes in pregnancies among women with lupus. Previously, lupus patients have been advised not to become pregnant, due to potential health risks for both mom and baby. Researchers at the Hospital for Special Surgery in New York City, NY, led the 10-year prospective, multi-center study PROMISSE (Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid antibody Syndrome and Systemic lupus Erythematosus) – the results of which are published in the Annals of Internal Medicine. Lupus, or systemic lupus erythematosus, is an autoimmune disease that mostly affects women of childbearing age. The disease can attack healthy tissue in the skin, joints, kidneys, brain and other organs. Previously, lupus patients have been advised not to become pregnant, due to potential health risks for both mom and baby. However, the results of PROMISSE – which researchers say is the largest multi-ethnic, multi-racial prospective study of lupus pregnancies – may help women with lupus to decide whether it is safe for them to become pregnant. Across eight sites in the US and Canada, 385 pregnant women were enrolled in the study between September 2003 and December 2012. The women joined the study during the first 12 weeks of their pregnancies and they had inactive or stable mild to moderate lupus activity at that time. 81% of pregnancies did not involve complications The study found that 81% of the pregnancies in the study did not involve complications. In 5% of pregnancies, fetal or neonatal death occurred. Preterm deliveries occurred in 9% of the pregnancies, and 10% of the babies had a low birth weight. Principal investigator Dr. Jane E. Salmon says of the results: The findings revealed that most of these pregnancy complications were linked to one or more of the following risk factors: A specific antiphospholipid antibody in the blood History of hypertension Low platelet count. “It was exciting to see that severe lupus flares occurred in less than 3% of women during pregnancy,” says Dr. Salmon. She added: “Lupus patients and their doctors can be confident of a good pregnancy outcome in most cases if lupus is quiescent when they become pregnant. Our findings now allow clinicians to identify the patients at high risk and manage them accordingly.” Recently, the European League Against Rheumatism (EULAR) issued recommendations on reducing risk to women’s health and pregnancy in patients with lupus and antiphospholipid syndrome. These included the recommendation that lupus patients who are planning a pregnancy should be counseled and managed after an assessment of risk, and that fertility preservation methods and assisted reproduction techniques may be considered. Measure Measure
  3. Large proportion of pregnancies in women with SLE are uncomplicated Buyon J, et al. Annals Int Med. 2015;doi:10.7326/M14-2235. June 22, 2015A large proportion of childbirths to patients with systemic lupus erythematosus occurred without complications, and outcomes were not related to anti-dsDNA antibodies, according to research published in The Annals of Internal Medicine. “For those patients who had a poor outcome, we were able to identify specific risk factors,” lead study author Jill P. Buyon, MD, director of the division of rheumatology and director of the lupus center at New York University Langone, told Healio.com/Rheumatology in an interview. “Happily, most of the women did do very well with their pregnancies.” Buyon and colleagues studied the outcomes of 385 pregnant women with systemic lupus erythematosus (SLE) between September 2003 and December 2012 at eight locations in the U.S. and one in Canada. Consecutive pregnant women with up to 12 weeks of gestation were recruited into the PROMISSE study. Eligibility criteria included age between 18 years and 45 years; presence of a single, intrauterine pregnancy; and hematocrit levels above 26%. Exclusion criteria were use of prednisone at doses greater than 20 mg daily, a ratio of protein to creatinine greater than 1,000 mg/g, presence of urine erythrocyte casts, diabetes, serum creatinine above 1.2 mg/dL and blood pressure above 140/90 mm Hg. Patients underwent a physical examination that included a complete blood count; comprehensive metabolic panel; urinalysis; detection of antibodies including anti-dsDNA, anti-Ro, anti-La, antiphospholipid (aPL) anti-beta-2-glycoprotein I and anticardiolipin; lupus anticoagulant; and C3 and C4 levels. Disease activity was measured at baseline and follow-up using the Systemic Lupus Erythematosus Pregnancy Disease Activity Index (SLEPDAI), and a flare composite was derived from the composite used in the SELENA (Safety of Estrogens in Lupus Erythematosus, National Assessment) trial. Adverse pregnancy outcomes (APOs) were defined as fetal death after 12 weeks of gestation (not attributable to anatomic malformation, chromosomal abnormalities or congenital infection) or as neonatal death prior to hospital discharge related to prematurity, placental insufficiency or both. Other APOs included preterm delivery before 36 weeks caused by gestational hypertension, placental insufficiency or preeclampsia, or an outcome of small-for-gestational-age neonate (low birthweight). One or more APOs were observed in 19% of the participants, with fetal death in 4% of the cohort. Neonatal death occurred in 1% of patients, preterm delivery occurred in 9% of patients, low birthweight was present in 10% of the children, and 17 patients had more than one APO. Preeclampsia was observed in 2% of patients after 36 weeks. Severe flares were observed in 2.5% of patients in the second trimester and in 3% of patients in the third trimester. In patients without aPL antibodies, rates of APOs were 15.4% compared with 43.8% in patients with aPLs and 3% in patients without SLE. Other risk factors included non-white race, hypertension and low platelet counts, according to the researchers. “Going into pregnancy counseling, the physician can use these parameters to discuss the risks with the patient,” Buyon said. “Helping patients manage their expectations is important. If a patient knows she may have a small baby or a premature baby, she can seek out appropriate care, such as a high-risk obstetrician or a hospital with a center dedicated to premature babies.” For some patients, finding appropriate care may involve travel and additional research to find appropriate specialists, but Buyon said these steps could mitigate some of the risk, and that future research is needed to understand and mitigate the risk factors identified. Buyon said that in the past, because of the role estrogen has been believed to play in SLE, many women were advised to avoid pregnancy; however, most of the women in her study had good outcomes. This study builds on some of her earlier work focused on estrogens and birth control medications in women with SLE, she said. Regarding the role of estrogen, Buyon said there is much to learn. “Things are more complicated than we have thought,” Buyon said. “As in life, biology is more complex than we can predict.” – by Shirley Pulawski Disclosures: Buyon reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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