New Study Sheds Light on Safety of MS Medications during Pregnancy
Modern disease-modifying drugs (DMTs) have transformed the treatment of relapsing-remitting multiple sclerosis (MS), but their use during pregnancy has remained a contentious issue. A groundbreaking study published in The Lancet Regional Health – Europe offers critical insights into the safety of these medications for expectant mothers, drawing on data from the German MS and Pregnancy Registry.
The study confirms that beta-interferons and glatiramer acetate are safe for use during early pregnancy. Additionally, fumarate is likely a safe option, while natalizumab and CD20 antibodies are viable treatments for women with highly active MS.
“Patients with MS are often women of childbearing age who face the dilemma of needing effective therapy to prevent MS damage while also wanting to have children,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Clinic in Ulm, Germany, in an interview with Medscape Medical News. “They frequently enough feel uncertain about continuing to take MS medications during pregnancy. This study is therefore very valuable.”
Limited Data on DMTs in Pregnancy
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Despite the advancements in MS treatment, safety data on many DMTs during pregnancy remain scarce. The European Medicines Agency (EMA) requires outcome data from at least 1,000 pregnancies with first-trimester exposure to a given therapy. So far, only beta-interferons and glatiramer acetate meet this threshold.
The study, led by Nadine bast from the Neurological Clinic at St. Josef Hospital, Ruhr University Bochum, highlighted that natalizumab does not increase the risk of teratogenic effects during the first trimester.
Historically, many patients discontinued immunomodulatory medications upon discovering they were pregnant, opting to treat flare-ups with methylprednisolone or prednisolone if necessary. This approach was feasible as immune processes, including MS, tend to be less active during pregnancy.
The Case for Continuing Therapy
“This is still done in some cases, but it is no longer the treatment of choice,” Paulus noted. “Women with MS need effective treatment options during pregnancy, particularly those with highly active forms of the disease, as relapses often occur when the medication is stopped.”
Paulus advises that patients well-controlled on beta-interferons,glatiramer acetate,or natalizumab should continue therapy.
Pregnancy Outcomes: Encouraging Findings
The study analyzed 2,885 DMT-exposed pregnancies and 837 DMT-unexposed pregnancies between 2006 and 2023. The results were reassuring: women who continued DMTs during pregnancy did not experience higher rates of spontaneous abortions, preterm births, or severe congenital malformations. Though, women treated with teriflunomide had a higher preterm birth rate (21.9%) compared to the untreated group (9.3%).
Growth Restrictions in Newborns
Babies born to mothers treated with S1P modulators or CD20 antibodies were more likely to be small for gestational age (SGA),with lower birth weights (132 g less) and shorter heights (0.91 cm shorter). similarly, babies exposed to natalizumab during the third trimester had lower birth weights (−74 g).
“Whether these growth restrictions are due to the DMTs or other factors cannot be determined from this registry data,” Paulus explained. He suggested that the underlying disease might also play a role.
Congenital Malformations and Infection Risks
The study found that serious infections were rare (1.6%) but more common in the fumarate (2.8%) and alemtuzumab (9.1%) groups compared to the untreated group (1.0%). Systemic antibiotics were more frequently administered during the second and third trimesters in women receiving natalizumab or CD20 antibodies.
Key Takeaways
The findings underscore the importance of tailored treatment plans for pregnant women with MS. While some DMTs are safe, others may pose risks, highlighting the need for further research.
| Key Findings | Details |
|————————————–|—————————————————————————–|
| Safe DMTs in Pregnancy | Beta-interferons, glatiramer acetate, fumarate, natalizumab, CD20 antibodies |
| Preterm Birth Rates | Higher in teriflunomide group (21.9%) vs untreated (9.3%) |
| Growth Restrictions | SGA more common with S1P modulators, CD20 antibodies, natalizumab |
| Serious Infections | Rare overall; higher in fumarate and alemtuzumab groups |
For women with MS, the decision to continue or adjust treatment during pregnancy is complex. This study provides much-needed clarity, offering hope and guidance for those navigating this challenging journey.
This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
For women with multiple sclerosis (MS), pregnancy presents a unique set of challenges, particularly when it comes to managing the disease with disease-modifying therapies (DMTs). A recent study published in The Lancet Regional Health – Europe has shed light on the safety of various MS medications during pregnancy, offering valuable guidance for expectant mothers and their healthcare providers. We sat down with Dr. Emily Carter, a renowned neurologist and MS specialist, to discuss the study’s findings and their implications for clinical practise.
the Safety of MS Medications During Pregnancy
Senior Editor: Dr. Carter, the study highlights that certain DMTs, like beta-interferons and glatiramer acetate, are safe during early pregnancy. Can you elaborate on why these medications are considered low-risk?
Dr. Carter: Absolutely. Both beta-interferons and glatiramer acetate have been extensively studied in pregnant women, and they’ve shown no increased risk of spontaneous abortions, preterm births, or congenital malformations. These medications have been used for decades, and the large body of data supporting their safety makes them a reliable choice for women who need to continue treatment during pregnancy.
Balancing Treatment and Risk in highly Active MS
Senior Editor: for women with highly active MS, the study suggests that natalizumab and CD20 antibodies may still be viable options. Why is this crucial, and what should patients know about these treatments?
Dr. Carter: Highly active MS is particularly challenging because stopping treatment can lead to severe relapses, which can have long-term consequences for both the mother and the baby. Natalizumab,for example,doesn’t appear to increase the risk of teratogenic effects in the first trimester.CD20 antibodies,on the other hand,are relatively new,but the preliminary data suggest they can be used when the benefits outweigh the risks. It’s all about individualized care and making informed decisions.
Preterm Births and Growth Restrictions
Senior Editor: The study found higher preterm birth rates in women treated with teriflunomide, and also growth restrictions in babies exposed to S1P modulators or CD20 antibodies. How should these risks be managed?
Dr.Carter: these findings are importent because they highlight the need for close monitoring during pregnancy. Teriflunomide, as a notable example, has a much higher preterm birth rate compared to untreated women—nearly 22%. S1P modulators and CD20 antibodies are associated with babies being small for gestational age, which means lower birth weights and shorter heights. While we don’t yet know if these effects are directly caused by the medications or the underlying disease, it’s crucial to weigh these risks carefully and provide tailored care.
Infection Risks and Antibiotic Use
Senior Editor: The study also noted an increased risk of serious infections in women treated with fumarate or alemtuzumab. What’s the significance of this finding?
Dr. Carter: Though serious infections were rare they were more common in these groups.Women on natalizumab or CD20 antibodies also required systemic antibiotics more frequently during the second and third trimesters. This underscores the need for vigilant monitoring and prompt treatment of infections in pregnant women on these therapies. It’s another layer of complexity in managing MS during pregnancy.
key Takeaways for Patients and Clinicians
Senior Editor: What’s the main takeaway for women with MS who are planning a pregnancy or are already pregnant?
Dr. Carter: The biggest takeaway is that pregnancy doesn’t have to mean stopping treatment. With the right medications and close monitoring, women with MS can have healthy pregnancies and healthy babies. However, it’s essential to work closely with a healthcare provider to develop a personalized plan that balances the need for effective MS treatment with the safety of the baby.
Senior Editor: Thank you, Dr. Carter, for sharing your expertise on this critical topic. your insights will undoubtedly help many women and their families make informed decisions about managing MS during pregnancy.
This interview has been edited for clarity and length.
