Reduction in maternal autoantibodies with intravenous immunoglobulin therapy during pregnancy

Abstract

The prevalence of autoimmune lupus has increased with the onset of disease typically occurring during the women’s reproductive years. As a result, many women are experiencing obstetric complications associated with lupus, including neonatal lupus (NL) syndrome. In particular, pregnant women who have elevated anti-Ro/SSA antibodies carry an increased risk of developing NL syndrome with the most serious complication being congenital complete heard block (CHB). Currently, there is no effective treatment for CHB and affected children often require cardiac pacemakers if they survive past delivery. Recent studies have shown an association between the concentration of anti-Ro/SSA antibodies and risk of fetal cardiac damage in NL. While the exact etiology of CHB is unknown, a therapeutic intervention aimed at reducing the concentration of these pathogenic antibodies may prevent the progression of cardiac NL in high risk pregnancies. This proposal is a pilot, double-blind, placebo-controlled randomized study assessing the effect of IVIG therapy on the change in concentration of maternal autoantibodies throughout pregnancy. Secondary outcomes will include 2nd and 3rd degree CHB. This study could potentially add to current evidence supporting the use of IVIG therapy in anti-Ro/SSA positive mothers to prevent the development of cardiac NL. If efficacious, it would also provide clinicians a safe and cost-effective option for women at risk of delivering a child with CHB.