Use of multiple sclerosis disease-modifying therapies during pregnancy in France: Nationwide study between 2010 and 2021

Mult Scler. 2024 Feb;30(2):227-237. doi: 10.1177/13524585231223395. Epub 2024 Jan 27.

Abstract

Background: Multiple sclerosis (MS) frequently affects women of childbearing age and pregnant women.

Objective: To assess the use of MS disease-modifying therapies (DMTs) during pregnancy in France over the last decade, marked by an increasing DMTs availability.

Methods: All pregnancies ended from April 2010 to December 2021 in women with MS were identified based on the nationwide Mother-Child Register EPI-MERES, built from the French National Health Data System (Système National des Données de Santé (SNDS)).

Results: Of a total of 20,567 pregnancies in women with MS, 7587 were exposed to DMT. The number of DMT-exposed pregnancies markedly increased from 1079 in 2010-2012 to 2413 in 2019-2021 (+124%), especially those exposed to glatiramer acetate, natalizumab, dimethyl fumarate, and anti-CD20. Among pregnancies of women on DMT 6 months before pregnancy, 78.0% underwent DMT discontinuation and 7.6% switched DMT, generally before (33.0% and 77.0%, respectively) or during the first trimester of pregnancy (58.3% and 17.8%, respectively). DMT discontinuation decreased from 84.0% in 2010-2012 to 72.4% in 2019-2021 and was less frequent among women aged ⩾35 years and those socioeconomically disadvantaged.

Conclusion: Despite MS therapeutic management adaptations to pregnancy, exposure during pregnancy to treatments whose safety profile has not yet been clearly established has increased sharply over the last decade.

Keywords: French National Health Data System; Multiple sclerosis; disease-modifying therapy; drug utilization study; pregnancy.

MeSH terms

  • Dimethyl Fumarate / therapeutic use
  • Female
  • France / epidemiology
  • Glatiramer Acetate / therapeutic use
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Multiple Sclerosis* / drug therapy
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy
  • Natalizumab / adverse effects
  • Pregnancy

Substances

  • Natalizumab
  • Glatiramer Acetate
  • Dimethyl Fumarate
  • Immunosuppressive Agents