• Lupus Clinical Trials
• Pregnancy

Exposure to fluorinated steroids does not seem to have an impact on fetal survival in cardiac neonatal lupus (NL), with the possible exception of fetuses with hydrops. Available data are discordant regarding the efficacy of fluorinated steroids in the prevention of fetal mortality in cardiac-NL. In a study in which patients with fetal complete atrioventricular (AV) block were treated with dexamethasone, mortality at 1 year was 10%, compared with a mortality rate of 54% in historical controls, although the historical controls used clearly had much higher rates of poor prognostic factors [Jaeggi ET et al. Circulation 2004]. In contrast, no significant effect of treatment with fluorinated steroids on mortality was observed in a retrospective multicenter study of 175 fetuses diagnosed with second- or third-degree AV block [Eliasson H et al. Circulation 2011].

Similarly, the available data on the prevention of cardiac-NL with the use of fluorinated steroids are limited, with one study that showed effective prevention of congenital heart block with maternal fluorinated or nonfluorinated steroids [Shinohara K et al. Obstet Gynecol 1999] and a review that failed to find utility of prophylactic treatment of congenital heart block [Costedoat-Chalumeau N et al. Rev Med Interne 2003].

Given the uncertainty over the benefit of fluorinated steroids and the maternal and fetal risks associated with these agents, the use of fluorinated steroids on the survival of fetuses with cardiac-NL and the protection from recurrent disease was investigated by Peter M. Izmirly, MD, New York University School of Medicine, New York, New York, USA. Data sources for the investigation were the Research Registry for Neonatal Lupus (RRNL) and an international historical control of 257 pregnancies following the birth of a child with cardiac-NL (which comprised cases in the US-based RRNL, France, and the United Kingdom). The outcomes assessed were fetal survival at 6 months and the recurrence rate of cardiac-NL.

Of the 276 cardiac-NL pregnancies in families enrolled in the RRNL, 150 were treated with fluorinated steroids and 126 were not. Gestational age at detection was 22.1 weeks in those treated with fluorinated steroids versus 24.4 weeks in those not treated (p<0.0001). The average dose of dexamethasone in those treated was 4.1 mg for an average duration of 10.9 weeks. Of fetuses with isolated third-degree block at presentation, there were 2 deaths at 6 months in the 78 treated with fluorinated steroids and no deaths in the 74 not treated with fluorinated steroids.

Any benefit to fluorinated steroids appeared to be restricted to those cases associated with hydrops: 13 of 27 (48.1%) with hydrops who were treated with fluorinated steroids were alive at 6 months compared with 1 of 10 (10.0%) not treated with fluorinated steroids (p=0.059).

There was no difference in the case fatality rate among treated and nontreated patients with at least 2 poor prognostic risk factors (heart rate ≤50 beats/minute, dilated cardiomyopathy, or endocardial fibroelastosis; Table 1).

Among the international historical controls of pregnancies following the birth of a child with cardiac-NL, the overall recurrence rate was 19.1%, with no significant difference in the recurrence rate between those treated and not treated with fluorinated steroids (14.3% vs 19.3%; p=0.58; Table 2).

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