Multi-National Gilenya Pregnancy Exposure Registry in MS patients

• Research type

  Research Study

• Full title

  The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

• IRAS ID

  99150

• Contact name

  Martin Lee

• Contact email

  martin.lee@nnuh.nhs.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Research summary

  Summary of Results

  This is a non-interventional study conducted in 18 counties worldwide from 2012 to 2024.The overall goal is to prospectively collect and evaluate safety data on fingolimod exposure immediately before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy on pregnancy outcomes for comparing the maternal, fetal, and infant outcomes in the registry to the background frequency from reference populations.

  Main objective:
  To describe the overall frequency of major and minor congenital malformations associated with exposure to fingolimod during pregnancy.

  Results:
  312 women were enrolled. 286 of the pregnancies recorded a known pregnancy outcome, involving 289 infants. Out of the 289 infants, 25 were confirmed to have a malformation. The observed prevalence of major congenital malformations using the EUROCAT and MACDP classification systems in infants born to mothers with fingolimod exposure is higher than the prevalence observed in the general population. For three organ systems, higher prevalence of Major Congenital Malformation compared to the general population was reported.
  • congenital heart defects
  • urinary malformations
  • limb/musculoskeletal malformations
  

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0330

• Date of REC Opinion

  5 Dec 2012

• REC opinion

  Further Information Favourable Opinion