番茄社区

ORLANDO -- Women with inflammatory bowel disease or relapsing multiple sclerosis who became pregnant while taking the sphingosine-1-phosphate (S1P) receptor modulator ozanimod (Zeposia) did not appear to have a higher risk of complications, despite warnings that pregnancy should be avoided while on the drug.

Of the 78 pregnancies in women participating in the ozanimod clinical development program, 42 live births occurred. Among these, one baby was born with a congenital anomaly (duplex kidney), four were born premature but without congenital anomalies, and 37 of the newborns had no congenital anomalies, reported Marla Dubinsky, MD, co-director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai in New York City.

During her poster presentation at the Advances in Inflammatory Bowel Diseases annual meeting, Dubinsky also noted that there were 12 spontaneous abortions, and 15 women elected to terminate their pregnancies. Six pregnancies were ongoing, and information about four others could not be determined. There was one twin pregnancy -- one baby was born alive, one was lost spontaneously.

"While clinical experience with ozanimod during pregnancy is limited and pregnancy should be avoided when taking ozanimod and for 3 months after discontinuing use of ozanimod to allow for drug elimination, there was no increased incidence of fetal abnormalities or adverse pregnancy outcomes with ozanimod exposure during early pregnancy in this small cohort of patients," Dubinsky said, adding that the outcomes observed "were comparable to the expected ranges within the general population."

The researchers also looked at pregnancies that occurred among the partners of men who were taking ozanimod, for whom 29 pregnancies occurred, resulting in 21 live births, one spontaneous abortion, and no elective terminations. There was one ongoing pregnancy, and seven without follow-up information.

Dubinsky said that among the live births, 13 had no congenital anomalies, and five were born prematurely, four of whom were healthy, with unknown outcome in the fifth child. Three abnormalities occurred: one child was diagnosed with Hirschsprung's disease, one had congenital hydrocele, and one child was born with a partial atrioventricular septal defect.

"Estimated exposure to ozanimod and its metabolites in partners of patients administered ozanimod was negligible and does not represent a clinically meaningful risk to partners or potential embryos," Dubinsky noted.

Julian Remouns, DO, a gastroenterology fellow at Main Line Health Lankenau Medical Center in Wynnewood, Pennsylvania, told 番茄社区 that "women should avoid becoming pregnant while on ozanimod, but the information in this study would make me more comfortable in suggesting that they could continue their pregnancy. I would withhold ozanimod as soon as I learned of the pregnancy, and hold it until after the pregnancy ended."

"I don't know if this single study will change my recommendations regarding ozanimod and pregnancy overall, but I would hope to see more studies along this line that could provide more definitive information," he added.

Dubinsky noted that, as an S1P receptor modulator, ozanimod could have an impact on the development of vascular formation in embryos, and preclinical data also have indicated that ozanimod could have a deleterious effect on embryonic development. Patients are counseled to use effective contraception while on ozanimod.

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