Director of Medical Affairs Janssen Biologics BV, Leiden, The Netherlands, Netherlands
Background: There is limited data for the class of S1P receptor modulators in pregnant women. Based on animal studies, adverse effects on embryofetal development and teratogenicity have been noted. Post-marketing data from another S1P receptor modulator suggest that its use is associated with an increased risk of major congenital malformations.
Objectives: To estimate the proportion of major congenital malformations associated with exposure to ponesimod immediately before and during pregnancy in live births, still births and termination of pregnancy for fetal anomaly (TOPFA).
Methods: POEM is based on secondary use of data collected via enhanced pharmacovigilance monitoring from post-marketing reports and reports from the ponesimod clinical trials. Follow-up will include duration of pregnancy, and the infant will be followed up to 12 months after birth. Enhanced monitoring consists of targeted questionnaires collecting information to evaluate pregnancy, fetal and infant outcomes, and additional follow-up attempts. Adjudication of congenital anomaly/birth defect will be performed by independent external experts to validate the outcome and to determine if the malformation was major/minor. Study duration will be 10 years or until 500 prospective pregnancy cases with known outcome are collected.
Results: A global enhanced pharmacovigilance program may be used to address a post-authorization safety study requirement. The design and process set up for the Pregnancy Outcomes Enhanced Monitoring (POEM) program to evaluate reproductive and embryofetal toxicity in pregnant women exposed to ponesimod are presented.
Conclusions: Enhanced pharmacovigilance monitoring through POEM should allow a faster and accurate assessment of the risk of reproductive and embryofetal toxicity in pregnant women exposed to ponesimod.
.jpg "Anja Geldhof, PhD (she/her/hers) photo")
