(109) Use of Fingolimod and Teriflunomide in Women of Childbearing Age and During Pregnancy in Germany

Publication Number: 1154

Background: Fingolimod (FGL) and teriflunomide (TFL) have been marketed in Germany for the treatment of relapsing remitting multiple sclerosis since 2011 and 2013, respectively, accompanied by risk minimization measures due to their teratogenic potential. Real-world data on their use in girls/women of childbearing age are scarce.

Objectives: To assess trends in the use of FGL and TFL in girls/women of childbearing age, characterize users and estimate the number of pregnancies occurring under treatment with FGL or TFL in Germany.

Methods: Using the German Pharmacoepidemiological Research Database (GePaRD, claims data from ~20% of the German population), we conducted cross-sectional analyses among girls/women aged 13-49 years to determine age-standardized prevalences of FGL and TFL use for each year until 2018 (numerator: girls/women with ≥1 dispensation in the respective year; denominator: mid-year population). We characterized users with regard to their age and the specialty of the prescribing physician. Furthermore, we conducted a cohort analysis to determine the number of pregnancies occurring during FGL/TFL treatment. For that purpose, we assigned an exposure window to each dispensation (date of dispensation + number of dispensed defined daily doses) and assessed whether it overlapped with the onset of pregnancy. This study was financed by the German Federal Institute for Drugs and Medical Devices (BfArM).

Results: We identified 3,684 and 2,057 girls/women with ≥1 dispensation of FGL (2011-2018) and TFL (2013-2018), respectively. For FGL, the age-standardized prevalence of use per 1,000 females increased from 0.14 in 2011 to 0.48 in 2018; for TFL, it increased from 0.06 in 2013 to 0.27 in 2018. About 60% of FGL users and about 45% of TFL users were ≤40 years of age. 85% of FGL dispensings and 87% of TFL dispensings were prescribed by neurologists. Overall, we identified 74 pregnancies exposed to FGL and 15 pregnancies exposed to TFL at the onset of pregnancy. For FGL, the number of exposed pregnancies increased to 116 when the exposure window was extended by two months to take into account the delayed elimination of FGL.

Conclusions: Use of FGL and TFL among women of childbearing age has substantially increased in Germany since their authorization. A high proportion of users was in age groups in which pregnancies typically occur. Despite risk minimization measures, there are pregnancies exposed to FGL and TFL in Germany.