Ozanimod-Exposed Pregnancy Outcomes in Women With MS, UC, and Crohn Disease

Although there has been no evidence of fetal abnormalities or adverse pregnancy outcomes, pregnancy should be avoided while on or within 3 months of taking ozanimod, according to study results presented at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held from May 31 to June 3 in Aurora, Colorado.

Ozanimod is an oral medication that modulates sphingosine-1-phosphate receptor 1 (S1PR1) and sphingosine-1-phosphate receptor 5 (S1PR5), which are involved in vascular formation in embryogenesis. The drug is approved for the treatment of relapsing forms of multiple sclerosis (MS) and moderate to severe active ulcerative colitis (UC) and is being studied for the treatment of Crohn disease (CD).

For the study, researchers reviewed available data on pregnancy among patients who were involved in the ozanimod clinical development program. The women of childbearing potential who participated in the program were required to use effective contraception while receiving and for 3 months after discontinuing ozanimod; however, 78 pregnancies occurred.

The patients who became pregnant while taking ozanimod had relapsing MS (n=57), UC (n=14), or CD (n=6) and 1 was a volunteer control individual.

All exposure events occurred in the first trimester. All women who did not wish to have an elective pregnancy termination discontinued medication immediately.

The overall rate of spontaneous abortion was 15% and the preterm birth rate was 10%.

Among women with MS, there were 33 live births, 5 ongoing pregnancies, 8 spontaneous early losses, 10 elective terminations, and 2 losses to follow-up. Among the live births, 1 congenital abnormality of duplex kidney occurred and 4 births were premature.

No case of teratogenicity was reported.

The researchers concluded, “Pregnancy should be avoided in patients taking and 3 months after stopping ozanimod. Clinical experience with ozanimod during pregnancy is limited, and there has been no increased incidence of fetal abnormalities or adverse pregnancy outcomes seen with ozanimod exposure in early pregnancy in a small cohort of patients.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.