Zeposia treatment during early pregnancy may be safe in MS: Study
Outcomes were studied in 78 pregnancies among patients, healthy volunteers
Treatment with Zeposia (ozanimod) during early pregnancy may be safe for women with multiple sclerosis (MS), or inflammatory bowel diseases, a recent study suggests.
Specifically, receiving the treatment during the first trimester of pregnancy didn’t increase the incidence of fetal malformations or adverse pregnancy outcomes, including premature birth and spontaneous abortion, compared to the general population. Similar results were obtained for pregnant partners of people with MS.
No participant was exposed to the treatment after the first trimester, however. “Thus, the safety of ozanimod later in pregnancy remains unclear,” the researchers wrote in “Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn’s Disease, and Relapsing Multiple Sclerosis,” which was published in Inflammatory Bowel Diseases.
In MS, the immune system mistakenly attacks and destroys the myelin sheath, a protective coating around nerve fibers essential for the nervous system to function as it should.
Zeposia is approved for adults with relapsing forms of MS and ulcerative colitis, and is being evaluated for Crohn’s disease. It works by binding to the sphingosine 1-phosphate (S1P) receptor on the surface of immune cells, keeping them inside lymph nodes, where immune cells are matured and stored. Zeposia can also enter the brain and may promote the survival of nerve cells and oligodendrocytes, which are myelin-producing cells. Both ulcerative colitis and Crohn’s are inflammatory bowel diseases that lead to chronic inflammation in the gastrointestinal tract.
“Currently, there are no adequate and well-controlled clinical studies on developmental risks associated with the use of ozanimod [Zeposia] in pregnant women,” the researchers wrote.
Studying early pregnancy outcomes in MS with Zeposia
In this study, scientists in the U.S. reported pregnancy outcomes in 78 pregnancies among 6,057 patients and healthy volunteers who received Zeposia, including 2,973 people with relapsing MS and 2,225 with inflammatory bowel diseases. All were enrolled in clinical trials of Zeposia, which were funded by Bristol Myers Squibb, the therapy’s marketer.
All exposures to the treatment occurred during the first trimester. All the patients discontinued the medication after the pregnancy was confirmed, except for those who chose to terminate the pregnancy. Zeposia’s prescribing information recommends avoiding pregnancy while on the medication.
Among pregnant women, 57 had relapsing MS and gave birth to 33 children, one with growth retardation during late pregnancy but subsequent normal development. Another birth showed a congenital abnormality (a duplex kidney, two ureters, rather than one, coming from a single kidney). Eight pregnancies ended due to spontaneous abortions and 10 due to elective terminations. Similar outcomes were reported among women with ulcerative colitis or Crohn’s disease who received Zeposia.
“In patients … who had ozanimod exposure during early pregnancy, incidences of spontaneous abortion, preterm birth, and congenital abnormalities were comparable to the expected ranges within the general population,” the researchers said.
Moreover, 29 partners of patients with relapsing MS or inflammatory bowel diseases, or healthy volunteers who received Zeposia, became pregnant. Among the 21 live births, five were premature and three had a congenital abnormality, which were not suspected to be treatment-related. One spontaneous abortion and no elective terminations were reported.
“However, the sample size was small, and it is possible that partner pregnancies were underreported, as some partners of patients in the ozanimod clinical development program declined to give consent,” wrote the investigators, who said future studies should address pregnancy outcomes in larger groups of pregnant women or pregnant partners of people treated with Zeposia. The higher number of pregnancies in the MS group compared to those with an inflammatory bowel disease is likely the result of the greater number of MS patients on ozanimod and longer study durations in this disease, they said.
“Studies analyzing pregnancy outcomes of patients exposed to ozanimod later in pregnancy are also needed to provide a more complete profile of ozanimod safety during pregnancy,” the researchers said.
A registry is currently monitoring pregnancy outcomes in MS patients treated with Zeposia, or other MS medications, during pregnancy.
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