Pregnancy Outcomes with Ozanimod: Data from the Clinical Development Program

Background: Ozanimod HCl (RPC1063) is an oral, once-daily immunomodulator that selectively targets sphingosine 1-phosphate receptors 1 and 5 (S1P_R1 and S1P_R5) in development for treatment of patients with relapsing multiple sclerosis (RMS).

Objectives: To review pregnancy data from the ozanimod clinical development program.

Methods: As of October 2, 2017, the ozanimod clinical development program sponsored by Celgene included 2917 subjects with RMS, who were required to use reliable contraception and immediately discontinue study drug in the event of pregnancy.

Results: In clinical RMS trials, 21 pregnancies were reported among ozanimod-treated subjects. There were 13 live births (61.9%), 2 spontaneous early losses (9.5%; 1 vanishing twin, with remaining fetus born healthy; 1 miscarriage), and 7 elective terminations (33.3%). The 13 live births resulted in healthy full-term newborns, one of which exhibited late intrauterine growth retardation and was born at 38 weeks weighing 2.130 kg. All exposures occurred during the first trimester; all subjects discontinued study medication. There were 3 partner pregnancies; 2 resulted in live healthy newborns and one had unknown status. The incidence of spontaneous abortion among ozanimod-exposed participants was consistent with the expected rate of early pregnancy loss in the general population (12–22%) (García-Enguídanos, 2002). No teratogenicity was observed.

Conclusions: Although there are no adequate and well-controlled studies in pregnant women, all known exposures to ozanimod during pregnancy in the clinical development program occurred during the first trimester, with no signal of an increased risk of fetal abnormalities or adverse pregnancy outcomes associated with gestational exposure.