Becoming pregnant when your lupus is clinically stable may be the key to fewer flares and a safer pregnancy, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Francisco, Calif.

Systemic lupus erythematosus, also called SLE or lupus, is a chronic inflammatory disease that can affect the skin, joints, kidneys, lungs, nervous system, and/or other organs of the body. The most common symptoms include skin rashes and arthritis, often accompanied by fatigue and fever. Lupus occurs mostly in women, typically developing in individuals in their twenties and thirties – prime child-bearing age.

Pregnancy in lupus can be challenging for the patients and the doctors who treat them, and some women experience frequent disease flares during their pregnancies.

Researchers recently set out to determine the frequency, severity and timing of lupus flares in pregnant patients and the impact those flares have on their pregnancies. They studied 198 mainly Caucasian patients with lupus in a multi-center, prospective observational study. Participants were enrolled when they were 12 weeks or less along in their pregnancies. Of these women, 28 percent had previously suffered from kidney disease, and most patients were taking medications to treat their lupus. Researchers evaluated the participants each month to determine if they experienced any disease flares using the SLE Pregnancy Disease Activity Index—an instrument that takes into account the physiologic changes of pregnancy and incorporates measurements of lupus activity—and by following changes in clinical parameters and medications as well physician’s overall assessments of health.

Researchers found that the initial SLE Pregnancy Disease Activity Index did not change significantly at weeks 20 and 32. There were few disease flares among these patients during the study. Researchers reported six percent, five percent, and eight percent of patients had mild to moderate flares at 20 weeks, 32 weeks and post partum, respectively. They also reported zero, less than one percent and one and-a-half percent severe flares at 20 weeks, 32 weeks and post partum, respectively.

There were four severe flares during the 198 pregnancies: two involving the central nervous system, one involving kidney disease, and the other was an arthritis flare. Pregnancy complications—including fetal or neonatal death, preeclampsia and fetal growth restriction—occurred in 15 percent of patients. Abnormalities of blood associated with active lupus including hypocomplementemia and double stranded DNA were not associated with flares or poor pregnancy outcomes.

Overall, researchers determined that mild to moderate flares were very infrequent in pregnant women with lupus who were clinically stable at conception – even in the presence of hypocomplementemia or history of kidney disease. The outcomes of these women’s pregnancies were found to be favorable as well.

“Our large prospective study underscores the reassuring message that women with lupus are likely to have uncomplicated pregnancies if they conceive while their lupus is inactive and they are taking less than 20 mg of prednisone, even if they have had renal involvement, explain Jane E. Salmon, MD; Collette Kean research chair, co-director, Kirkland Center for Lupus Research Hospital for Special Surgery; professor of medicine,Weill Medical College of Cornell University, New York, N.Y. and Jill P. Buyon, MD; Professor of Medicine, New York University School of Medicine, New York, N.Y., lead investigators in the study. “In addition, our study suggests that maintaining hydroxychloroquine therapy through pregnancy may be beneficial and free of untoward effects on the fetus. We believe our results allow lupus patients and their doctors to approach discussions about pregnancy with optimism.”

The ACR is an organization of and for physicians, health professionals, and scientists that advances rheumatology through programs of education, research, advocacy and practice support that foster excellence in the care of people with or at risk for arthritis and rheumatic and musculoskeletal diseases. For more information on the ACR’s annual meeting, see http://www.rheumatology.org/annual.

Presentation Number: 1708

Low Flare Rates and Favorable Fetal Outcomes in Lupus Pregnancies

Jane E. Salmon1, Mimi Kim2, Phuong Le1, Marta Guerra1, Carl Laskin3, Ware Branch4, Lisa Sammaritano1, Michelle Petri5, Joan T. Merrill6, Michael Lockshin1, Jill P. Buyon7. 1Hospital for Special Surgery, New York, NY; 2Albert Einstein Coll of Medicine, Bronx, NY; 3Mt. Sinai Hospital, Toronto, ON, Canada; 4Univ of Utah HSC, New York, NY; 5Johns Hopkins Univ School of Medicine, Baltimore, MD; 6Oklahoma Medical Research Fdn, Oklahoma City, OK; 7New York University, New York, NY

Purpose: Pregnancy in lupus is a challenge for patients and physicians, and high rates of lupus flare still occur in some cohorts. Our goal was to determine the severity, frequency, and timing of flares and the fetal outcomes in women with stable or mildly active disease at conception.

Methods: We studied 198 patients with ≥4 ACR SLE criteria in the PROMISSE Study (Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid antibody Syndrome and Systemic lupus Erythematosus), a multicenter prospective observational study. Subjects were enrolled at

<12 weeks’ gestation and evaluated monthly. Exclusion criteria were multi-fetal pregnancy, prednisone >

20mg, proteinuria > 1gm/24 hr, and creatinine > 1.2 mg/dl. Flares were defined using a novel instrument (SLEPDAI: SLE Pregnancy Disease Activity Index) which takes into account physiologic changes of pregnancy, but otherwise incorporates the components of the SELENA-SLEDAI flare index. Mild/moderate and severe flares were defined by numerical score on SLEPDAI, changes in clinical parameters and medications, and physician’s global assessment. Subjects were: Caucasian = 56%, Black = 19%, Asian = 11%, Hispanic = 13%, previous renal disease = 28%. At enrollment: anti-dsDNA positive = 39%, HCQ use = 53%, prednisone use = 39% (daily doses = 1-10mg: 30%; 11-20mg: 8%), mean creatinine = 0.66 mg/dl ± 0.16; mean SLEPDAI 2.9 ± 2.9.

Results: SLEPDAI did not change from baseline: median changes at 20 wks and 32 wks were 0. Flare rates in PROMISSE were low: mild/moderate flare at 20 wks = 6%, at 32 wks = 5%, post partum = 8%; severe flare at 20 wks = 0%, 32 wks <1%, postpartum = 1.5%. In 198 pregnancies, there were 4 severe flares: 2 CNS, 1 renal, and 1 arthritis. Flares (mild/moderate) may be more common in patients not receiving HCQ at enrollment (23% vs. 14%, p=0.14). Pregnancy complications, including fetal or neonatal death, preeclampsia and fetal growth restriction (<10%ile) occurred in only 15% of patients. Hypocomplementemia or anti-dsDNA positivity at enrollment was not associated with these poor pregnancy outcomes or with lupus flare.

Conclusions: Mild/moderate and severe flares were extremely infrequent in pregnant lupus patients who are clinically stable at conception, even in the presence of anti-dsDNA antibodies and/or past history of renal disease. Similarly, pregnancy outcomes were favorable in such patients. Our findings provide data to advise SLE patients considering pregnancy.

Disclosure Block: J.E. Salmon, NIH AR49772, 2; M. Kim, NIH AR49772, 2; P. Le, None; M. Guerra, None; C. Laskin, NIH AR49772, 2; W. Branch, NIH AR49772, 2; L. Sammaritano, NIH AR49772, 2; M. Petri, NIH AR49772, 2; J.T. Merrill, NIH AR49772, 2; M. Lockshin, NIH AR49772, 2; J.P. Buyon, NIH AR49772, 2.

Source: American College of Rheumatology (ACR)