Women with inflammatory bowel disease (IBD) or relapsing multiple sclerosis (RMS) who become pregnant while taking the sphingosine-1-phosphate (S1P) receptor modulator ozanimod (Zeposia) may not be at a higher risk of complications, according to a recent study. Despite previous warnings against pregnancy while on the drug, researchers found that there was no increased incidence of fetal abnormalities or adverse pregnancy outcomes in women taking ozanimod during early pregnancy. These findings provide some reassurance to patients and healthcare providers regarding the safety of pregnancy while using ozanimod.
The study analyzed 78 pregnancies in women participating in the ozanimod clinical development program. Out of these pregnancies, 42 resulted in live births, with only one baby born with a congenital anomaly (duplex kidney). Four babies were born premature but without congenital anomalies, and 37 newborns were born without any congenital anomalies. There were also 12 spontaneous abortions and 15 elective terminations. Six pregnancies were ongoing, and information about four others could not be determined. The study also examined pregnancies in partners of men taking ozanimod and found that out of 29 pregnancies, 21 resulted in live births, one in spontaneous abortion, and none in elective termination. Three abnormalities were reported in the live births, including Hirschsprung’s disease, congenital hydrocele, and a partial atrioventricular septal defect.
The research team emphasized that clinical experience with ozanimod during pregnancy is limited, and therefore pregnancy should generally be avoided while taking the drug and for three months after discontinuing its use to allow for drug elimination. However, they found that the outcomes observed in this study were comparable to the expected ranges within the general population. While ozanimod is an S1P receptor modulator that could potentially affect vascular formation in embryos, the study did not find any significant increase in fetal abnormalities or adverse pregnancy outcomes with ozanimod exposure during early pregnancy. The study also noted that estimated exposure to ozanimod in partners of patients taking the drug was negligible and not clinically meaningful.
Gastroenterology experts have expressed cautious optimism about these findings. Dr. Julian Remouns, a gastroenterology fellow, suggests that while women should still avoid becoming pregnant while on ozanimod, the study provides some comfort in suggesting that they could continue their pregnancy if it occurred. He recommends withholding ozanimod as soon as a pregnancy is confirmed and resuming its use only after the pregnancy ends. Dr. Remouns calls for more studies to provide more definitive information on the safety of ozanimod and pregnancy.
The study on pregnancy outcomes in women taking ozanimod for IBD or RMS provides valuable insights into the safety of the drug during pregnancy. While caution should still be exercised, the study suggests that becoming pregnant while on ozanimod may not necessarily lead to higher risks of complications or fetal abnormalities. Healthcare providers should continue to counsel patients on the importance of effective contraception while taking ozanimod and discuss individualized plans for managing pregnancy. Further research is needed to establish more conclusive evidence on the safety of ozanimod and pregnancy.