The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

Systemic lupus erythematosus (SLE) predominantly affects women during their reproductive years. As SLE is associated with substantial fetal and maternal morbidity during pregnancy and beyond it is crucial to identify predictors of adverse pregnancy outcomes (APO) in SLE to appropriately counsel patients and guide monitoring during pregnancy. SLE pregnancies result in high rates of preterm birth, preeclampsia and fetal loss compared to pregnancies in unaffected women.

As a prior effort to address this issue, team members performed a large prospective study (the PROMISSE study) to determine baseline predictors of APO in SLE women with inactive and mild/moderate disease activity. However, PROMISSE included a selected population, which might not be representative of all SLE women particularly those with severe disease activity and/or active nephritis. Furthermore new data suggest that antiphosphatidylserine/prothrombin antibodies (aPS/PT), which are antiphospholipid antibodies (aPL), are strongly associated with APO. These antibodies were not evaluated in the PROMISSE study, or any other study of SLE pregnancies to date. Moreover, despite evidence of the beneficial effect of aspirin (ASA) in non-SLE women at high risk of APO, there are currently no studies of ASA in SLE pregnancies. This is a critical knowledge gap as ASA could have a large benefit for SLE mothers and their offspring.

The goal is to evaluate adverse pregnancy outcomes (APO), their predictors, and potential preventive therapies. The investigator aims to improve the outcomes for women with SLE and their offspring. Primary outcomes of this study are to determine the risk of APO in this cohort, as well as to evaluate the patterns of ASA use in the LEGACY cohort. Secondary outcomes will be to conduct pilot analyses to assess baseline predictors of APO determined in the PROMISSE study (i.e. lupus anticoagulant (LAC) positivity, antihypertensive use, platelets level, race/ethnicity, prior nephritis, disease activity), and to evaluate prevalence of aPS/PT in SLE pregnancies.

Design: In order to achieve these objectives, clinical data and blood sample results obtained through the McGill University Health Centre (MUHC) LEGACY Biobank (directed by Dr. Evelyne Vinet) will be analyzed. Patient recruitment, consent, management and storage of data/samples will be done in accordance with the Biobank Management Framework. The LEGACY Biobank informed consent forms will be used to obtain participant consent.

Methodology: Research activities will be conducted in accordance with the LEGACY Biobank Management Framework. English and French speaking pregnant SLE women will be enrolled up to and including the 16 6/7 weeks regardless of disease manifestations, level of disease activity and drug exposures. Pregnancies up to and including 12 weeks gestation will be targeted but pregnancies up until 16 6/7 weeks will be included. The attending staff or a nurse not involved with the study or the administrative assistant will introduce the study to pregnant women with Lupus. If patients are interested in learning more patients will be approached by coordinator who will explain the study in detail.