Abstract
Introduction
While the mean prevalence of Systemic Lupus Erythematosus (SLE) is 0.024% in the general population, it is more common among women of reproductive age and little is known about its impact on pregnancy outcomes. This study assessed the risk of Congenital Anomalies (CA) associated with a maternal diagnosis of SLE.
Material and Methods
A case-malformed control study was performed using data from the EUROmediCAT central database including livebirths, fetal deaths from 20 weeks gestational age and terminations of pregnancy for fetal anomaly. For registrants in each specific EUROCAT subgroup of non-genetic anomalies (cases), the odds of having a maternal SLE diagnosis (ICD-9/10-CM codes: M32.1, M32.8, M32.9 and 710) was compared with the odds of having a maternal SLE diagnosis in the remaining non-genetic anomalies or genetic conditions (malformed controls). Subgroups with ≥ 3 exposed cases were analysed. Reporting odds ratios (ROR) with 95% Confidence Intervals (95% CI) were estimated using exact Fisher test if less than 5 exposed cases. P-values were adjusted for multiple testing using the false discovery rate (FDR) method.
Results
Data included 253,911 registrants with CA in 12 European countries from 1995–2020. Sixty registrants (49 non-genetic and 11 genetic) had a mother with a SLE diagnosis. Maternal SLE diagnosis was associated with an increased risk of urinary system anomaly (ROR 2.09, 95% CI 1.11-3.94; 13 exposed cases) compared with non-genetic controls. When adjustment for multiple testing was made, the associations were no longer statistically significant. While compared to genetic control the risk of urinary system anomaly (ROR 1.29, 95% CI 0.58-2.89) was not statistically significant.
Conclusion
Although we found no significant increased risk of CA associated with a maternal SLE diagnosis after adjusting for multiple testing, the limited size of the exposed population likely constrained our ability to detect differences. These findings suggest close monitoring of pregnant women with SLE and further investigation to disentangle between the effects of the disease and the treatment.
While the mean prevalence of Systemic Lupus Erythematosus (SLE) is 0.024% in the general population, it is more common among women of reproductive age and little is known about its impact on pregnancy outcomes. This study assessed the risk of Congenital Anomalies (CA) associated with a maternal diagnosis of SLE.
Material and Methods
A case-malformed control study was performed using data from the EUROmediCAT central database including livebirths, fetal deaths from 20 weeks gestational age and terminations of pregnancy for fetal anomaly. For registrants in each specific EUROCAT subgroup of non-genetic anomalies (cases), the odds of having a maternal SLE diagnosis (ICD-9/10-CM codes: M32.1, M32.8, M32.9 and 710) was compared with the odds of having a maternal SLE diagnosis in the remaining non-genetic anomalies or genetic conditions (malformed controls). Subgroups with ≥ 3 exposed cases were analysed. Reporting odds ratios (ROR) with 95% Confidence Intervals (95% CI) were estimated using exact Fisher test if less than 5 exposed cases. P-values were adjusted for multiple testing using the false discovery rate (FDR) method.
Results
Data included 253,911 registrants with CA in 12 European countries from 1995–2020. Sixty registrants (49 non-genetic and 11 genetic) had a mother with a SLE diagnosis. Maternal SLE diagnosis was associated with an increased risk of urinary system anomaly (ROR 2.09, 95% CI 1.11-3.94; 13 exposed cases) compared with non-genetic controls. When adjustment for multiple testing was made, the associations were no longer statistically significant. While compared to genetic control the risk of urinary system anomaly (ROR 1.29, 95% CI 0.58-2.89) was not statistically significant.
Conclusion
Although we found no significant increased risk of CA associated with a maternal SLE diagnosis after adjusting for multiple testing, the limited size of the exposed population likely constrained our ability to detect differences. These findings suggest close monitoring of pregnant women with SLE and further investigation to disentangle between the effects of the disease and the treatment.
Original language | English |
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DOIs | |
Publication status | Published (in print/issue) - 30 Nov 2024 |
Event | 2024 ISPE Annual Meeting, Berlin, Germany - Berlin, Berlin, Germany Duration: 24 Aug 2024 → 28 Aug 2024 |
Conference
Conference | 2024 ISPE Annual Meeting, Berlin, Germany |
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Country/Territory | Germany |
City | Berlin |
Period | 24/08/24 → 28/08/24 |