Inflammatory bowel disease (IBD) and relapsing multiple sclerosis (RMS) are chronic conditions that can pose challenges for women who become pregnant. One such challenge is the use of sphingosine-1-phosphate (S1P) receptor modulators like ozanimod. While there have been warnings about the potential risks associated with taking ozanimod during pregnancy, recent research suggests that these concerns may be unfounded. This article examines the safety of ozanimod in pregnant women, shedding light on the outcomes and complications observed during the clinical development program.
A study conducted by Marla Dubinsky, MD, and her team explored the pregnancies of women enrolled in the ozanimod clinical development program. Out of the 78 pregnancies, 42 resulted in live births. Surprisingly, only one baby was born with a congenital anomaly (duplex kidney), indicating a low risk of fetal abnormalities. Four premature births without congenital anomalies were also reported, while the remaining 37 newborns had no congenital anomalies. Although there were 12 spontaneous abortions and 15 elective terminations, the study shows that the incidence of complications associated with ozanimod exposure during early pregnancy was not significantly higher than that of the general population.
The study expanded its scope to pregnancies among partners of men taking ozanimod. Out of the 29 pregnancies, 21 resulted in live births, with only one spontaneous abortion and no elective terminations. Similar to the results observed in pregnant women, the incidence of congenital anomalies was relatively low. Thirteen live births had no congenital anomalies, while five were born prematurely, but four remained healthy. Three abnormalities were detected, including Hirschsprung’s disease, congenital hydrocele, and partial atrioventricular septal defect. The estimated exposure to ozanimod and its metabolites in partners was deemed negligible, suggesting a minimal risk to the partners or potential embryos.
The findings of this study provide reassurance to healthcare providers and patients alike. However, it is important to note that caution is still advised concerning pregnancy while on ozanimod. Dr. Julian Remouns, a gastroenterology fellow, suggests that women should avoid becoming pregnant while on ozanimod. In the event of pregnancy, he recommends promptly discontinuing the medication until after the pregnancy has concluded. While this single study may not be sufficient to change recommendations regarding ozanimod and pregnancy, further research is needed to provide more definitive information.
Ozanimod, as an S1P receptor modulator, has the potential to affect vascular formation during embryo development. Preclinical studies have indicated a potential deleterious effect on embryonic development. Consequently, patients are counseled to use effective contraception while taking ozanimod, highlighting the importance of discussing family planning and medications with healthcare professionals.
The study conducted on the pregnancies of women taking ozanimod revealed encouraging findings. The occurrence of congenital anomalies and adverse pregnancy outcomes was not significantly higher in this cohort of patients compared to the general population. However, caution is still recommended for women who are pregnant or planning to conceive while taking ozanimod. Healthcare providers should continue to monitor their patients closely and promptly discontinue the medication in the event of pregnancy. Although this study provides valuable insights, further research is warranted to solidify the understanding of the safety profile of ozanimod during pregnancy.
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