8359
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated with Mayzent (siponimod): An OTIS Observational Pregnancy Surveillance Study
Mayzent (siponimod) is an oral sphingosine 1-phosphate receptor modulator indicated in the United States (US) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and in the US and Canada active secondary progressive disease. Data on Mayzent exposure during pregnancy is limited. The OTIS Mayzent Pregnancy Exposure Registry is a US-based study designed to monitor pregnancy and infant outcomes among women in the US and Canada. Pregnancy registries are an important component of post-marketing surveillance to assess the safety of new medications. Presented is an overview of the study design and recruitment into this pregnancy study.
Objectives:
The study will assess the risks of major structural birth defects, spontaneous abortion, elective termination, stillbirth, preterm delivery, preeclampsia/ eclampsia, pattern of 3 or more minor structural defects, small for gestational age, postnatal growth and developmental performance at approximately 1 year of age, and serious or opportunistic infections in the first year of life in pregnancies exposed to Mayzent compared to a disease comparison (DC) group, and a healthy comparison (HC) group.
Methods:
This OTIS research study is a North American, prospective cohort study comparing pregnancy outcomes in participants exposed to Mayzent to a DC group without Mayzent exposure, and to a HC group. Participants exposed to Mayzent during pregnancy who do not meet the eligibility criteria are enrolled into a “case series” and these data may be used to illuminate any findings in the cohort study. Recruitment began in December 2021 and will continue through 2028, with a goal of 289 participants in each cohort. The study captures data on exposures, outcomes and covariates through maternal interviews and maternal and pediatric medical records, a pediatric dysmorphology exam, and developmental screening of the child using the Ages and Stages online questionnaire. Disease severity is measured by maternal questionnaire.
Results:
Between December 15, 2021 and March 21, 2022, 9 participants were enrolled into the cohort study, 0 Mayzent-exposed, 1 DC, and 8 HC.
Conclusions:
With the help of neurologists, especially those specializing in the care of patients with MS, this study will collect information that will help healthcare professionals and their patients make informed treatment decisions during pregnancy.