Abstract
Introduction
Multiple sclerosis (MS) can be diagnosed in women of childbearing age, raising the question of the impact of the disease and MS drugs on pregnancy outcomes. As part of the ConcePTION study, we assessed the risk of congenital anomalies (CAs) associated with maternal MS.
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. We assessed the risk of CAs in women with a recorded diagnosis of MS and/or who had been exposed to an MS-specific drug. Cases from 80 EUROCAT subgroups of non-genetic anomalies were compared with malformed controls (all other non-genetic anomalies or genetic conditions). Subgroups with ≥3 exposed cases were analyzed. Reporting Odds ratios adjusted (aROR) for year of birth, maternal age and registry, with 95% Confidence Intervals (95% CI) were estimated. P-values were adjusted for multiple testing.
Results
There were 253,911 registrants with CAs in 12 European countries from 1995 to 2020. 20 women had both an MS diagnosis and a prescription for an MS-specific drug, 86 women had an MS diagnosis only and 10 women had a prescription for an MS-specific drug only. Among the 116 CAs from registrants with MS, 95 were non-genetic CAs and 21 were genetic CAs. 22 subgroups with more than 3 cases of MS were analysed. An increased risk of gastroschisis was associated with maternal MS status compared with non-genetic controls and with genetic controls (aROR 6.57, 95%CI: 2.05-21.05, adjusted p-value=0.044 and aROR 12.22, 95%CI: 3.48-42.93, adjusted p-value=0.022 respectively; 3 exposed cases).
Conclusion
We found an increased risk of gastroschisis following maternal MS status during pregnancy. However, maternal illness is under-recorded in the central database, these findings therefore require further investigation and verification in other independent studies.
Multiple sclerosis (MS) can be diagnosed in women of childbearing age, raising the question of the impact of the disease and MS drugs on pregnancy outcomes. As part of the ConcePTION study, we assessed the risk of congenital anomalies (CAs) associated with maternal MS.
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. We assessed the risk of CAs in women with a recorded diagnosis of MS and/or who had been exposed to an MS-specific drug. Cases from 80 EUROCAT subgroups of non-genetic anomalies were compared with malformed controls (all other non-genetic anomalies or genetic conditions). Subgroups with ≥3 exposed cases were analyzed. Reporting Odds ratios adjusted (aROR) for year of birth, maternal age and registry, with 95% Confidence Intervals (95% CI) were estimated. P-values were adjusted for multiple testing.
Results
There were 253,911 registrants with CAs in 12 European countries from 1995 to 2020. 20 women had both an MS diagnosis and a prescription for an MS-specific drug, 86 women had an MS diagnosis only and 10 women had a prescription for an MS-specific drug only. Among the 116 CAs from registrants with MS, 95 were non-genetic CAs and 21 were genetic CAs. 22 subgroups with more than 3 cases of MS were analysed. An increased risk of gastroschisis was associated with maternal MS status compared with non-genetic controls and with genetic controls (aROR 6.57, 95%CI: 2.05-21.05, adjusted p-value=0.044 and aROR 12.22, 95%CI: 3.48-42.93, adjusted p-value=0.022 respectively; 3 exposed cases).
Conclusion
We found an increased risk of gastroschisis following maternal MS status during pregnancy. However, maternal illness is under-recorded in the central database, these findings therefore require further investigation and verification in other independent studies.
Original language | English |
---|---|
DOIs | |
Publication status | Published (in print/issue) - 19 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 |
---|---|
Country/Territory | Germany |
City | Berlin |
Period | 24/08/24 → 28/08/24 |