Key Summary:
- Adverse pregnancy outcomes affected up to 82% of higher-risk patients.
- Pregnancy complications were more frequent in women not in lupus remission.
- Broader outcome definitions revealed a greater burden of complications.

WOMEN with systemic lupus erythematosus (SLE) who are not in remission may face an increased risk of adverse pregnancy outcomes, according to findings from a prospective cohort study examining pregnancy complications across different disease severity groups.
Researchers found that adverse pregnancy outcome rates varied substantially depending on patient characteristics and the definitions used to classify complications. The findings also highlighted the potential importance of achieving disease remission before pregnancy, particularly among women with additional clinical risk factors.
SLE is associated with an increased risk of pregnancy complications, including preterm birth, pre-eclampsia, pregnancy loss, and adverse neonatal outcomes.
Previous research, particularly the Predictors of Pregnancy Outcomes: Biomarkers in Antiphospholipid Syndrome and SLE (PROMISSE) study, has established important benchmarks for pregnancy outcomes in women with SLE.
However, PROMISSE excluded certain high-risk patients and used relatively narrow definitions of adverse pregnancy outcomes, potentially underestimating the burden of complications across the broader SLE population.
To investigate these limitations, researchers prospectively evaluated 107 pregnancies in 107 individuals with SLE, excluding only multifetal pregnancies.
Participants were divided into two subgroups: 90 who met PROMISSE eligibility criteria and 17 higher-risk individuals who would have been excluded because of clinical factors including significant proteinuria, hypertension, elevated serum creatinine, high-dose prednisone use, or diabetes.
Adverse pregnancy outcomes were assessed using both PROMISSE definitions and selected American College of Obstetricians and Gynecologists (ACOG) criteria.
Researchers also examined whether remission status, assessed using the Definition of Remission in SLE (DORIS), was associated with pregnancy outcomes.
Using PROMISSE definitions, adverse pregnancy outcomes occurred in 30% of the overall cohort.
However, substantial differences emerged between patient groups. Complications affected 24% of PROMISSE-eligible patients compared with 59% of higher-risk patients who did not meet the original study’s eligibility criteria.
When researchers applied the broader ACOG definitions, adverse pregnancy outcome rates increased across all groups.
Under these criteria, complications occurred in 50% of the total cohort, 43% of PROMISSE-eligible patients, and 82% of higher-risk PROMISSE-ineligible patients.
These findings demonstrate how both study inclusion criteria and outcome definitions can substantially influence estimates of pregnancy risk in women with SLE.
The particularly high complication rates among patients with additional clinical risk factors also suggest that estimates derived from lower-risk populations may not adequately reflect outcomes across routine clinical practice.
Disease activity emerged as another important factor associated with pregnancy outcomes.
Adverse pregnancy outcomes, particularly preterm birth and pre-eclampsia, occurred more frequently among patients who had not achieved DORIS remission.
Notably, all three neonatal deaths and all three pregnancy losses recorded in the cohort occurred among individuals who were not in remission.
These observations suggest that remission status may provide clinically relevant information when assessing pregnancy risk in women with SLE.
However, the study was observational, and the findings do not establish that achieving remission directly prevents pregnancy complications.
The relatively small higher-risk subgroup also limits the precision and generalisability of estimates for these patients.
The researchers emphasised that the high rate of adverse pregnancy outcomes among PROMISSE-ineligible patients reflected a population with clinical characteristics for which pregnancy would often be deferred until disease optimisation.
The findings therefore reinforce the importance of individualised preconception counselling, particularly for women with active SLE or additional risk factors.
Assessing disease activity, remission status, and underlying clinical characteristics before pregnancy may help clinicians provide more informed risk estimates and support shared decision-making.
The researchers concluded that adverse pregnancy outcome rates in SLE depend strongly on the population studied and the definitions applied. Across disease severity groups, complications were more frequently observed among women who had not achieved DORIS remission, highlighting the potential value of disease optimisation when planning pregnancy.
Reference
Hernández-Blanco C, Carlucci PM, Carter E, Lippman B, Izmirly P, Engel A, et al. Prospective evaluation assessing the influence of outcome definition, cohort inclusion and DORIS remission in predicting adverse pregnancy outcomes in women with systemic lupus erythematosus. Lupus Science & Medicine. 2026;13:e002210. https://doi.org/10.1136/lupus-2026-002210
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