Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Yvonne Geissbühler; Jere Vile; Gideon Koren; Morgane Guennec; Helmut Butzkueven; Hugh Tilson; Thomas M. MacDonald; Kerstin Hellwig

doi:10.1177/1756286418804760

Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Yvonne Geissbühler (Lead / Corresponding author), Jere Vile, Gideon Koren, Morgane Guennec, Helmut Butzkueven, Hugh Tilson, Thomas M. MacDonald, Kerstin Hellwig

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Abstract

Background and Methods: Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.

Results: The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.

Conclusions: These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.

Original language	English
Pages (from-to)	1-9
Number of pages	9
Journal	Therapeutic Advances in Neurological Disorders
Volume	11
Early online date	3 Nov 2018
DOIs	https://doi.org/10.1177/1756286418804760
Publication status	Published - 2018

Keywords

congenital malformations
fingolimod
miscarriages
multiple sclerosis
pregnancy

ASJC Scopus subject areas

Pharmacology
Neurology
Clinical Neurology

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10.1177/1756286418804760Licence: CC BY-NC

Final Published VersionFinal published version, 227 KBLicence: CC BY-NC

Cite this

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title = "Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure",

abstract = "Background and Methods: Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.Results: The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.Conclusions: These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.",

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AU - Geissbühler, Yvonne

AU - Vile, Jere

AU - Koren, Gideon

AU - Guennec, Morgane

AU - Butzkueven, Helmut

AU - Tilson, Hugh

AU - MacDonald, Thomas M.

AU - Hellwig, Kerstin

PY - 2018

Y1 - 2018

N2 - Background and Methods: Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.Results: The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.Conclusions: These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.

AB - Background and Methods: Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.Results: The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.Conclusions: These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.

KW - congenital malformations

KW - fingolimod

KW - miscarriages

KW - multiple sclerosis

KW - pregnancy

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Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Abstract

Keywords

ASJC Scopus subject areas

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