Ponesimod Use and Teratogenicity Risk in Women With Multiple Sclerosis

Use of ponesimod in women with multiple sclerosis (MS) who are pregnant was not associated with a higher proportion of spontaneous abortions, according to a report presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held from June 1-4, 2022 in National Harbor, Maryland.

Historically, MS affects women at a rate 3 times higher than that of men and the range age of diagnosis is between 20 to 50 years of age. There have been studies done to assess whether external factors such as drug use could be correlated with the disease’s higher affinity towards women in this age range. There is limited data available to determine whether sphingosine-1-phosphate receptor modulators affect pregnant women, leading researchers to evaluate pregnancy outcomes in women exposed to ponesimod during pregnancy across phase 2 and 3 studies.

Of the 1062 women included in the review, 990 were diagnosed with MS. In total, there were 20 fetal exposures of ponesimod reported, all of which were during the 1st trimester. Outcomes were available for 18 of the 20 women. There were 6 normal newborns, 8 induced abortions, and 4 spontaneous abortions.

Of the 8 induced abortions, 5 showed no indication of fetal toxicity, 1 had benign hydatidiform mole, and 2 were unknown. Two outcomes were not reported due to ongoing pregnancy and loss to follow-up. Of the 12 induced and spontaneous pregnancies, unknown fetal abnormalities were reported in 11.

For women with MS who were exposed to ponesimod, the proportion of spontaneous abortion is not statistically different compared with both the general population and in groups of women with MS who were not exposed to ponesimod.

There is no teratogenicity associated with ponesimod exposure. However, given the limited clinical data, it is still recommended for women of childbearing potential to use effective contraception to avoid pregnancy during ponesimod treatment and for 1 week after discontinuation.

The researchers concluded that after “Recognizing the importance of collecting more information on pregnancy exposure, a multinational pregnancy outcomes enhanced monitoring program has been established to record prospective data on pregnancy outcomes in women exposed to [ponesimod].”

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

Reference

Rosas-Ballina M, Wooller A, Jones R, Vaclavkova A, Havrdova EK. Fetal exposure with ponesimod treatment across clinical development studies. Presented at: CMSC 2022 Annual Meeting; June 1-4, 2022; National Harbor, Maryland. Abstract DMT42.