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

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 bo

SUBMITTER: Karlsson G 

PROVIDER: S-EPMC3945658 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature