A comprehensive analysis of over 3,700 pregnancies in women diagnosed with multiple sclerosis (MS) has shown that most disease-modifying therapies (DMTs) do not increase the risks of miscarriage, premature birth, or serious birth defects. This study, led by Professor Kerstin Hellwig from the Department of Neurology at Ruhr University Bochum, Germany, provides significant insights into the safety of MS medications during pregnancy, published in The Lancet Regional Health Europe on December 2, 2024.
Study Overview
The study utilized data from the German Multiple Sclerosis and Pregnancy Registry, collected from November 2006 to June 2023. This large-scale cohort included 3,722 pregnancies, with 2,885 women having received various immunomodulating agents (DMTs) either before or during their pregnancies. These included interferons, glatiramer acetate, dimethyl fumarate, teriflunomide, S1P modulators (fingolimod, ponesimod), alemtuzumab, natalizumab, anti-CD20 antibodies (rituximab, ocrelizumab, ofatumumab), and cladribine. A control group consisted of 837 pregnancies in women who did not receive any MS medication.
Key Findings
No Increase in Major Pregnancy Risks: The primary finding was that exposure to most DMTs during pregnancy did not show a statistically significant increase in risks for spontaneous abortion, premature birth, or major birth defects.
Birth Weight Concerns: The study did find that babies born to mothers with MS had a slightly increased risk of lower birth weight, with 18.8% of babies falling below average weight, compared to the general population rate of 10% in Germany. This risk was particularly pronounced among those exposed to S1P modulators (27.4%) and anti-CD20 antibodies (24.1%).
Infections and Complications: Serious infections during pregnancy were relatively rare but occurred more frequently among those who had been treated with fumarates or alemtuzumab (2.8% and 9.1%, respectively). Notably, severe infections occurred in 0.6% of pregnancies exposed to anti-CD20 antibodies.
Duration of Medication Exposure: The study also examined the timing of drug exposure. For example, the use of natalizumab in the second or third trimester and anti-CD20 antibody exposure up to six months before the last menstruation was associated with a higher likelihood of requiring antibiotics during pregnancy.
Professor Hellwig emphasizes the importance of individual risk-benefit assessments when prescribing medications for MS during pregnancy. While the findings suggest that most MS therapies do not significantly increase pregnancy risks, some treatments may be associated with lower birth weights and may require additional monitoring. However, these risks need to be weighed against the potential benefits of continuing therapy to manage MS symptoms effectively during pregnancy.
The study also plans to explore whether children born with a lower birth weight may eventually catch up in growth and health, particularly considering the long-term risks of conditions such as type 2 diabetes and cardiovascular disease. The research highlights the necessity of ongoing monitoring and individualized care for women with MS who are pregnant.
This large cohort study provides valuable evidence that most MS medications, particularly when used in the early stages of pregnancy, do not increase the risk of miscarriage, premature birth, or major birth defects. However, some treatments can lead to complications like low birth weight, underlining the importance of personalized treatment plans and close supervision during pregnancy.
Ultimately, the findings offer reassurance to women with MS and their healthcare providers, showing that pregnancy can be successfully managed with careful planning and monitoring.
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