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February 25, 2014; 82 (8) Article

Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis

Goeril Karlsson, Gordon Francis, Gideon Koren, Peter Heining, Xiaoli Zhang, Jeffrey A. Cohen, Ludwig Kappos, William Collins
First published January 24, 2014, DOI: https://doi.org/10.1212/WNL.0000000000000137
Goeril Karlsson
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Gordon Francis
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Gideon Koren
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Peter Heining
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Xiaoli Zhang
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Jeffrey A. Cohen
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Ludwig Kappos
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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William Collins
From Novartis Pharma AG (G. Karlsson, P.H., W.C.), Basel, Switzerland; Novartis Pharmaceuticals Corporation (G.F., X.Z.), East Hanover, NJ; Motherisk Program (G. Koren), Hospital for Sick Children, Toronto, Canada; Neurological Institute (J.A.C.), Cleveland Clinic, OH; and Neurology and Department of Biomedicine (L.K.), University Hospital, Basel, Switzerland.
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Citation
Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis
Goeril Karlsson, Gordon Francis, Gideon Koren, Peter Heining, Xiaoli Zhang, Jeffrey A. Cohen, Ludwig Kappos, William Collins
Neurology Feb 2014, 82 (8) 674-680; DOI: 10.1212/WNL.0000000000000137

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Abstract

Objective: To report outcomes of pregnancies that occurred during the fingolimod clinical development program.

Methods: Pregnancy outcomes from phase II, phase III, and phase IV clinical studies (with optional extensions) were reported by clinical trial investigators. Fingolimod exposure in utero was defined as fingolimod treatment at the time of conception or in the 6 weeks before conception.

Results: As of October 31, 2011, 89 pregnancies were reported in completed or ongoing clinical studies, with 74 in fingolimod treatment arms. Of 66 pregnancies with in utero exposure to fingolimod, there were 28 live births, 9 spontaneous abortions, 24 elective abortions, 4 ongoing pregnancies, and 1 pregnancy with an unknown outcome (patient lost to follow-up). Two infants were born with malformations: 1 with congenital unilateral posteromedial bowing of the tibia and 1 with acrania. Elective abortions were performed for 1 case each of tetralogy of Fallot, spontaneous intrauterine death, and failure of fetal development. There were 5 cases (7.6%; 95% confidence interval 3%–17%) of abnormal fetal development in the 66 pregnancies that had in utero exposure to fingolimod. In all 5 cases, fetal exposure to the drug took place in the first trimester of pregnancy.

Conclusions: The number of patients becoming pregnant during fingolimod therapy remains small and does not permit firm conclusions to be drawn about fetal safety of fingolimod in humans. Given the known risks of teratogenicity in animals and the present data, women of childbearing potential should use effective contraception during fingolimod therapy and for 2 months after discontinuation.

GLOSSARY

CI=
confidence interval;
MS=
multiple sclerosis

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Editorial, page 654

  • Received October 23, 2012.
  • Accepted in final form October 14, 2013.
  • © 2014 American Academy of Neurology
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