Pregnancy outcomes in the clinical development program of fingolimod in MS

Treatment, therapies and management:

Fingolimod is a sphingosine 1-phosphate receptor modulator that has been approved as a once-daily oral therapy for relapsing remitting MS. It is known that modulation of the sphingosine 1-phosphate receptor is involved in vascular formation during embryogenesis. As preclinical studies have indicated a risk of fetal toxicity, women of childbearing potential entering into fingolimod clinical study protocols require a negative pregnancy test at enrolment and females of child bearing potential are required to use a reliable contraception throughout the duration of the treatment.

This study reports the outcome of pregnancies which occurred during the fingolimod clinical development program despite these measures. Seventy four pregnancies were reported in completed or ongoing trials in the fingolimod treatment arm, with 66 of these pregnancies having in utero exposure to fingolimod. There were 28 live births, nine spontaneous abortions, 24 elective abortions, four ongoing pregnancies and one pregnancy with an unknown outcome as the patient was lost to follow-up. One infant was born with congenital unilateral posteromedial bowing of the tibia and one with acrania.

Elective abortions were carried out due to a case of tetralogy of Fallot, a case of intrauterine death and a case of failure of development. To date the number of patients becoming pregnant during fingolimod treatment is small; however, due to the known risks of teratogenicity and the present data presented, females of childbearing potential should use effective contraception while on fingolimod therapy and for two months after stopping the therapy.

Authors: Karlsson G, Francis G
Source: Neurology. 2014 Jan 24. [Epub ahead of print]
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