Hydroxychloroquine to Prevent Recurrent Congenital Heart Block in Fetuses of Anti-SSA/Ro-Positive Mothers.

Journal of the American College of Cardiology
Peter M IzmirlyJ P Buyon

Abstract

Experimental and clinical evidence support the role of macrophage Toll-like receptor signaling in maternal anti-SSA/Ro-mediated congenital heart block (CHB). Hydroxychloroquine (HCQ), an orally administered Toll-like receptor antagonist widely used in lupus including during pregnancy, was evaluated for efficacy in reducing the historical 18% recurrence rate of CHB. This multicenter, open-label, single-arm, 2-stage clinical trial was designed using Simon's optimal approach. Anti-SSA/Ro-positive mothers with a previous pregnancy complicated by CHB were recruited (n = 19 Stage 1; n = 35 Stage 2). Patients received 400 mg daily of HCQ prior to completion of gestational week 10, which was maintained through pregnancy. The primary outcome was 2° or 3° CHB any time during pregnancy, and secondary outcomes included isolated endocardial fibroelastosis, 1° CHB at birth and skin rash. By intention-to-treat (ITT) analysis, 4 of 54 evaluable pregnancies resulted in a primary outcome (7.4%; 90% confidence interval: 3.4% to 15.9%). Because 9 mothers took potentially confounding medications (fluorinated glucocorticoids and/or intravenous immunoglobulin) after enrollment but prior to a primary outcome, to evaluate HCQ alone, 9 additional mother...Continue Reading

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Citations

Sep 11, 2020·Circulation. Arrhythmia and Electrophysiology·Deborah M FriedmanJill P Buyon
Nov 15, 2020·Scandinavian Journal of Immunology·Aurelie AmbrosiMarie Wahren-Herlenius
Jan 23, 2021·Expert Review of Clinical Immunology·Loukas ChatzisAndreas V Goules
Feb 9, 2021·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Roberta MilazzoIrene Cetin
Jan 9, 2021·Frontiers in Pediatrics·Sara De CarolisSilvia Salvi
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May 18, 2021·Frontiers in Cardiovascular Medicine·Hongyu LiaoYifei Li
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Jul 3, 2021·Journal of Clinical Medicine·Alina VedutaPaolo Cavoretto
Jul 18, 2020·Journal of the American College of Cardiology·Janette F Strasburger, Annette Wacker-Gussmann
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