Teriflunomide and Pregnancy Planning
The authors of the article published last year in Multiple Sclerosis Journal present data regarding experiences with the use of teriflunomide during pregnancy.
Treatment of MS in women of childbearing age
Teriflunomide is the only oral first-line disease-modifying drug (DMD) in the treatment of relapsing/remitting multiple sclerosis (MS). It is registered in 80 countries for this indication. It is administered at a dose of 14 mg once daily. Due to its tablet form, it is a relatively popular first choice in the treatment of this disease.
Given the high prevalence of MS in the population of childbearing women, a significant downside of teriflunomide is its contraindication in pregnancy. Women of childbearing age must use effective contraception during treatment with teriflunomide. Women who are taking teriflunomide and wish to become pregnant should discontinue the treatment and are advised to undergo accelerated elimination using, for example, cholestyramine or activated charcoal (plasma levels of teriflunomide must drop below 0.02 mg/l).
Teratogenicity of teriflunomide and its excretion into milk have been demonstrated in animal studies, and pregnant and breastfeeding women were therefore specifically excluded from subsequent clinical studies. Nevertheless, hundreds of cases have been reported where pregnant women used teriflunomide in real practice.
Evaluated data and findings
In clinical studies and the postmarketing phase, the authors recorded 437 women who took teriflunomide during pregnancy (70 from clinical studies, 367 from the postmarketing phase). Health information was obtained for 222 of these women’s offspring. The majority of these women were first-time mothers. A total of 107 pregnancies (48.2%) resulted in live births, 63 (28.4%) in induced abortions, 47 (21.2%) in spontaneous miscarriages, 3 (1.4%) in ectopic pregnancies, 1 woman (0.5%) was still pregnant at the time of evaluation, and 1 woman (0.5%) died during pregnancy.
A total of 4 children were born with congenital malformations (ureteropelvic junction obstruction, congenital hydrocephalus, ventricular septal defect, malformation of the right lower limb). The newborn with ureteropelvic junction obstruction was born at 36 weeks from a set of twins to a 34-year-old mother, a smoker exposed to teriflunomide during the first trimester. The boy with congenital hydrocephalus was born to a 26-year-old mother, a smoker, who took teriflunomide during the first month of pregnancy. His birth weight was 2.8 kg, and he was delivered at 37 weeks of pregnancy. A 38-year-old mother with gestational diabetes mellitus gave birth at 39 weeks to a child with a ventricular septal defect. She took teriflunomide during pregnancy for only 6 weeks. The newborn with the malformation of the right leg was born at 37 weeks to a mother who used teriflunomide up to 7.4 weeks of pregnancy.
Conclusion
The percentage of major congenital malformations in offspring of patients exposed to teriflunomide during pregnancy was comparable to the general population. These findings do not confirm the teratogenicity of teriflunomide.
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Source: Vukusic S., Coyle P. K., Jurgensen S. et al. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: clinical study data and 5 years of post-marketing experience. Mult Scler 2020 Jun; 26 (7): 829–836, doi: 10.1177/1352458519843055.
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