Study objective and method
A cross-sectional study
Danish Multiple Sclerosis Registry
5% sub-cohort of women from the general population using the Danish Civil Registration System
Assessment of adverse prenatal events*
Congenital
malformation
Low Apgar score
SGA
Preterm birth
Results
Conclusion
Prenatal teriflunomide exposure did not lead to an increase in the prevalence of:
Spontaneous abortions
Preterm birth
Congenital malformations
Low Apgar score
Being SGA
*In case of multiple adverse events registered to the same newborn, these were only accounted for as one event in the composite outcome. †Stillbirth was not included as an adverse event as no such event occurred in the study populations. Apgar: Appearance, pulse, grimace, activity, and respiration; Cl: Confidence interval; OR: Odds ratio; SGA: Small for gestational age.
Disclaimer: Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l. Pregnancy must be excluded before start of treatment.this study has not been reviewed by SFDA
MAT-BH-2300590-V1-Oct.2023