Sjögren Syndrome in Women Not Associated With Adverse Pregnancy Outcomes

Pregnancies in women with Sjögren syndrome were found to have good prognoses for both mothers and fetuses.

Women with primary Sjögren syndrome are not at an increased risk for adverse pregnancy outcomes, according to research results published in Lancet Rheumatology.

Researchers aimed to evaluate pregnancy outcomes in patients with primary Sjögren syndrome compared with the general population, as well as the factors predicting disease flares.

A multicenter prospective cohort study was conducted in France using GR2 (Group de Recherche sur la Grosses et les Maladies Rares) database.

Women who conceived before March 2021 with a diagnosis of primary Sjögren syndrome, defined by the American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) 2016 classification criteria were included in the study.

Researchers used EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) score to determine disease activity, which was classified in to 4 groups: none (score=0), mild score=1-4), moderate (score=5-13), and severe (score=≥14). A disease flare during pregnancy was defined as at least a 3-point increase in ESSDAI score during the second or third trimesters compared with baseline score.

Women should be screened for antiphospholipid antibodies and anti-RNP antibodies before conception…

Adverse pregnancy outcomes included unexplained intrauterine fetal death after at least 12 weeks of gestation; neonatal death within the first 28 days of life; placental insufficiency; hemolysis, elevated liver enzymes, low platelets (HELLP); and small-for-gestational-age (SGA) birthweight.

A total of 106 pregnancies to women with Sjögren syndrome were included in the study population, with 93 included in the flare analysis. At onset, 48 (45%) had a baseline ESSDAI score of 1 or more, with 25 (24%) with mild, 20 (19%) with moderate, and 3 (3%) with severe activity. A total of 102 women (96%) tested positive for anti-SSA antibodies.

Excluding 4 twin pregnancies and 1 medical termination, of the remaining 88 pregnancies, adverse outcomes occurred in 6 (7%): 2 intrauterine growth retardation, 1 intrauterine fetal demise at 13 weeks, 1 preeclampsia, 1 placental abruption, and 1 SGA birthweight.

Matched control analysis indicated adverse pregnancy outcomes in 9 (9%) of 105 pregnancies in women with primary Sjögren syndrome and 28 (7%) of 420 pregnancies in matched control participants (odds ratio [OR], 1.31; 95% CI, 0.53-2.98; P =.52). Adverse outcome frequency of preterm delivery, low birthweight, and cesarean sections were similar between women with primary Sjögren syndrome and matched control participants.

Study limitations included the low number of Sjogren syndrome flares and adverse pregnancy outcomes.

The study authors concluded, “Women should be screened for antiphospholipid antibodies and anti­-RNP antibodies before conception, and those who have [p]ositive results should be closely monitored, as these factors might be associated with a higher risk of complications.”

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Martin de Fremont G, Costedoat-Chalumeau N, Lazaro, et al. Pregnancy outcomes in women with primary Sjögren’s syndrome: an analysis of data from the multicentre, prospective, GR2 study. Lancet Rheumatol. Published online May 25, 2023. doi: 10.1016/S2665-9913(23)00099-1