Exploring the Safety of Ozanimod in Pregnancy: A Unique Perspective

Ozanimod, a sphingosine-1-phosphate (S1P) receptor modulator, has long been associated with warnings against its usage during pregnancy due to potential complications. However, a recent study presented at the Advances in Inflammatory Bowel Diseases annual meeting challenges this notion. The study examined the pregnancy outcomes of women with inflammatory bowel disease (IBD) and relapsing multiple sclerosis (RMS) who became pregnant while taking ozanimod. The findings suggest that the risks of complications may not be as high as previously believed.

In the clinical development program for ozanimod, a total of 78 pregnancies were observed, resulting in 42 live births. Among the live births, only one baby was born with a congenital anomaly, specifically a duplex kidney. Additionally, four babies were born premature but without any congenital anomalies. The majority of newborns (37 out of 42) showed no congenital anomalies. However, there were 12 spontaneous abortions and 15 women chose to terminate their pregnancies.

It is important to note that the study also analyzed pregnancies in partners of men taking ozanimod. Out of 29 pregnancies, 21 resulted in live births, one ended in spontaneous abortion, and there were no elective terminations. Among the live births, 13 had no congenital anomalies, while five were born prematurely. Three abnormality cases were reported, including Hirschsprung’s disease, congenital hydrocele, and a partial atrioventricular septal defect.

Dr. Marla Dubinsky, co-director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai in New York City, acknowledges that the clinical experience with ozanimod during pregnancy is limited and advises avoiding pregnancy while on the drug. However, the outcomes observed in this small cohort of patients were comparable to the expected ranges within the general population.

It is worth mentioning that previous preclinical data suggested a potential deleterious effect of ozanimod on embryonic development. The drug’s mechanism as an S1P receptor modulator could impact vascular formation in embryos. However, the study findings did not indicate an increased incidence of fetal abnormalities or adverse pregnancy outcomes associated with ozanimod exposure during early pregnancy.

While the study provides some reassurance regarding the safety of ozanimod during pregnancy, experts still exercise caution when prescribing the drug to pregnant women. Dr. Julian Remouns, a gastroenterology fellow, suggests that the study’s results should be considered when making recommendations but acknowledges the need for more definitive information through additional studies.

Healthcare professionals may advise women to avoid becoming pregnant while on ozanimod and to discontinue the drug as soon as they learn of the pregnancy. The importance of effective contraception while taking ozanimod is also emphasized. Overall, the study offers a unique perspective on the safety of ozanimod during pregnancy, highlighting the need for continued research and evaluation to ensure optimal patient care.

The study evaluating the outcomes of pregnancies in women taking ozanimod challenges the existing warnings against its usage during pregnancy. With comparable rates of complications to the general population, the study suggests that the risk of adverse events may not be as high as previously believed. However, caution should still be exercised when prescribing ozanimod to pregnant women, and further research is necessary to provide more definitive information. As with any medication, healthcare providers should carefully weigh the benefits and risks to ensure the well-being of both the mother and the fetus.


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