Maternal Use of Hydroxychloroquine is Associated with a Reduced Risk of Recurrent Anti-SSA/Ro Associated Cardiac Manifestations of Neonatal Lupus
Background—A recent case control study suggested a benefit of hydroxychloroquine (HCQ) in lowering the risk of cardiac manifestations of neonatal lupus (cardiac-NL) in pregnancies of anti-SSA/Ro positive patients with Systemic Lupus Erythematosus (SLE). A historical cohort assembled from three international databases was used to evaluate whether HCQ reduces the nearly tenfold increase in risk of recurrence of cardiac-NL, independent of maternal health status.
Methods and Results—Two hundred fifty seven pregnancies of anti-SSA/Ro positive mothers (40 exposed and 217 unexposed to HCQ) subsequent to the birth of a child with cardiac-NL were identified from three databases (U.S., England, and France). Exposure was defined as the sustained use of HCQ throughout pregnancy with initiation prior to ten weeks of gestation. The recurrence rate of cardiac-NL in fetuses exposed to HCQ was 7.5% (3/40) compared to 21.2% (46/217) in the unexposed group (p=0.050). While there were no deaths in the exposed group, the overall case fatality rate of the cardiac-NL fetuses in the unexposed group was 22%. In a multivariable analysis which adjusted for database source, maternal race/ethnicity, and anti-SSB/La status, HCQ use remained significantly associated with a decreased risk of cardiac-NL (Odds Ratio=0.23; 95% CI: 0.06-0.92; p=0.037). Similar results were obtained with propensity score analysis, an alternative approach to adjust for possible confounding by indication.
Conclusions—Based on aggregate data from a multinational effort, in mothers at high risk of having a child with cardiac-NL, the use of HCQ may protect against recurrence of disease in a subsequent pregnancy.
- Received December 22, 2011.
- Accepted May 15, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited