Journal of Neurology

, Volume 257, Issue 12, pp 2020–2023 | Cite as

Glatiramer acetate exposure in pregnancy: preliminary safety and birth outcomes

Original Communication

Abstract

With the increasing incidence of multiple sclerosis (MS) in women and the earlier use of disease modifying therapy (DMT), issues surrounding DMT and pregnancy are a regular subject of discussion with regards to optimal management. Current recommendations are to withdraw DMT prior to conception, leaving patients exposed to an uncertain period of untreated disease. The objective of this study is to report preliminary experience on glatiramer acetate (GA) exposure through conception, pregnancy and the post-partum period in a series of 13 patients with previously highly active relapsing-remitting MS. This is a prospective observational case series. Fourteen pregnancies of 13 women resulted in 13 live births (one twin pregnancy), nine exposed to GA throughout pregnancy. There were no birth defects and treatment was well tolerated. No relapses occurred during pregnancy in those continuing on treatment. In conclusion, our early experience suggests that when considering the risks and benefits of treatment withdrawal prior to pregnancy, it may be reasonable to continue GA in those patients with previously highly active disease. Consideration should also be given to the initiation of a birth register, similar to such initiatives in epilepsy, to generate more robust safety data in this controversial area.

Keywords

Multiple sclerosis Glatiramer acetate Pregnancy 

References

  1. 1.
    Fernandes LRA, Fernandes RP, Fragoso YD, Lippi UG (2007) Multiple sclerosis and pregnancy. Einstein 5:173–176Google Scholar
  2. 2.
    Lee M, O’Brien P (2008) Pregnancy and multiple sclerosis. J Neurol Neurosurg Psychiatry 79:1308–1311CrossRefPubMedGoogle Scholar
  3. 3.
    Confavreux C, Hutchinson M, Hours MM, Cortinovis-Tourniaire P, Moreau T, Pregnancy in Multiple Sclerosis Group (1998) Rate of pregnancy-related relapse in multiple sclerosis. N Engl J Med 339:285–291CrossRefPubMedGoogle Scholar
  4. 4.
    Saraste M, Ryynanen J, Alanen A, Multanen J, Farkkila M, Kaaja R, Airas L (2006) Cerebrospinal fluid findings in MS patients before, during, and after pregnancy. J Neurol Neurosurg Psychiatry 77:1195–1196CrossRefPubMedGoogle Scholar
  5. 5.
    Vukusic S, Hutchinson M, Hours M, Moreau T, Cortinovis-Tourniaire P, Adeleine P, Confavreux C, The pregnancy in multiple sclerosis group (2004) Pregnancy and multiple sclerosis (The PRIMS study): clinical predictors of post-partum relapse. Brain 127:1353–1360CrossRefPubMedGoogle Scholar
  6. 6.
    Boskovic R, Wide R, Wolpin J, Bauer DJ, Koren G (2005) The reproductive effects of beta interferon therapy in pregnancy: a longitudinal cohort. Neurology 65:807–811CrossRefPubMedGoogle Scholar
  7. 7.
    Sandberg-Wollheim M, Frank D, Goodwin TM, Giesser B, Lopez-Bresnahan M, Stam-Moraga M et al (2005) Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis. Neurology 65:802–806CrossRefPubMedGoogle Scholar
  8. 8.
    Putheti P, Soderstrom M, Link H, Huang YM (2003) Effects of glatiramer acetate (Copaxone) on CD4 + CD25 high T regulatory cells and their IL-10 production in multiple sclerosis. J Neuroimmunol 144:125–131CrossRefPubMedGoogle Scholar
  9. 9.
    Coyle PK, Johnson K, Stark Y, Pardo L (2003) Pregnancy outcomes in patients with multiple sclerosis treated with glatiramer acetate (Copaxone). J Neurol Neurosurg Psychiatry 74:443 [poster]Google Scholar
  10. 10.
    Weber-Schoendorfer C, Schaefer C (2009) Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study. Mult Scler 15:1037–1042CrossRefPubMedGoogle Scholar
  11. 11.
    Ramtahal J, Jacob A, Das K, Boggild M (2006) Sequential treatment with glatiramer acetate after mitoxantrone is safe and can limit exposure to immunosuppression in very active, relapsing remitting MS. J Neurol 253:1160–1164CrossRefPubMedGoogle Scholar
  12. 12.
    Miller A, DeAngelis T, Krieger S, Rooney-Crino A (2007) Use of glatiramer acetate during pregnancy: offering women a choice. Mult Scler 13: S7–S273 [abstract]Google Scholar
  13. 13.
    Ventura SJ, Martin JA, Curtin SC, Matthews TJ, Park MM (2000) Births: final data for 1998. Natl Vital Stat Rep 48:13–21Google Scholar
  14. 14.
    Adab N, Kini U, Vinten J, Ayres J, Baker G, Clayton-Smith J et al (2004) The longer term outcome of children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 75:1575–1583CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • Heidi J. Salminen
    • 1
  • Helen Leggett
    • 2
  • Mike Boggild
    • 2
  1. 1.Neonatal Unit, Women and Children’s DivisionWirral University Teaching Hospital NHS TrustWirralUK
  2. 2.Department of NeurologyThe Walton Centre for Neurology and NeurosurgeryLiverpoolUK

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