Project Details

Early Career

Status: Funded - Open

Effect of Hydroxychloroquine and Azathioprine exposure in pregnancy on neonatal outcomes

Stephen Balevic, MD


BACKGROUND: In pregnant women with systemic lupus erythematosus (SLE), neonatal complications are common and include preterm birth, critical care hospitalization, and low birth weight. To control maternal disease activity and prevent poor outcomes, over 70% of pregnant women with SLE receive hydroxychloroquine (HCQ) or azathioprine (AZA) during pregnancy; however, low systemic levels of HCQ and AZA are associated with increased disease activity and increased risk of disease flares in non-pregnant women.

GAP: The effect of pregnancy on systemic levels of HCQ and AZA, and the implications on dosing in pregnancy are unknown, resulting in an urgent, unmet public health need.

HYPOTHESIS: HCQ and AZA levels will decline with progression of pregnancy, thereby increasing maternal disease activity and worsening neonatal outcomes.

METHODS: This is a prospective cohort study and PK/PD analysis of patients enrolled in the Duke Autoimmunity in Pregnancy Registry. From this registry, we will enroll 72 patients with SLE on HCQ, as well as 42 patients with SLE on AZA.

RESULTS: Pending

IMPACT: Drug disposition information does not currently exist for anti-rheumatic medications during pregnancy. In this proposal, we will optimize neonatal outcomes by developing evidence-based dosing recommendations for the most commonly used anti-rheumatic drugs in pregnancy.