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Pregnancy outcomes from the Branded glatiramer acetate pregnancy database

Sandberg-Wollheim, Magnhild LU ; Neudorfer, Orit; Grinspan, Augusto; Weinstock-Guttman, Bianca; Haas, Judith; Izquierdo, Guillermo; Riley, Claire; Ross, Amy Perrin; Baruch, Peleg and Drillman, Talya, et al. (2018) In International Journal of MS Care 20(1). p.9-14
Abstract

Background: Appropriate counseling and treatment for women with multiple sclerosis (MS) who may become pregnant requires an understanding of the effects of exposure to disease-modifying therapies (DMTs) during pregnancy. Current reports and studies are limited in their usefulness, mostly by small sample size. Branded glatiramer acetate (GA) is a DMT approved for the treatment of relapsing forms of MS. For more than 2 decades, it has been shown to be efficacious and to have a favorable safety profile. The Teva Pharmaceutical Industries Ltd global pharmacovigilance database comprises data from more than 7000 pregnancies, during which women with MS were exposed to treatment with branded GA. Methods: We analyzed data from Teva's global... (More)

Background: Appropriate counseling and treatment for women with multiple sclerosis (MS) who may become pregnant requires an understanding of the effects of exposure to disease-modifying therapies (DMTs) during pregnancy. Current reports and studies are limited in their usefulness, mostly by small sample size. Branded glatiramer acetate (GA) is a DMT approved for the treatment of relapsing forms of MS. For more than 2 decades, it has been shown to be efficacious and to have a favorable safety profile. The Teva Pharmaceutical Industries Ltd global pharmacovigilance database comprises data from more than 7000 pregnancies, during which women with MS were exposed to treatment with branded GA. Methods: We analyzed data from Teva's global pharmacovigilance database. Pregnancy outcomes for patients treated with branded GA were compared with reference rates of abnormal pregnancy outcomes reported in two large registries representing the general population. Results: Pregnancies exposed to branded GA were not at higher risk for congenital anomalies than what is expected in the general population. Conclusions: These data provide evidence that branded GA exposure during pregnancy seems safe, without teratogenic effect.

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type
Contribution to journal
publication status
published
subject
in
International Journal of MS Care
volume
20
issue
1
pages
6 pages
publisher
Igitur publishing
external identifiers
  • scopus:85042466095
ISSN
1537-2073
DOI
10.7224/1537-2073.2016-079
language
English
LU publication?
no
id
9f6db950-8332-4b99-a968-13c3952bfdfe
date added to LUP
2018-03-09 10:25:19
date last changed
2018-06-24 05:21:06
@article{9f6db950-8332-4b99-a968-13c3952bfdfe,
  abstract     = {<p>Background: Appropriate counseling and treatment for women with multiple sclerosis (MS) who may become pregnant requires an understanding of the effects of exposure to disease-modifying therapies (DMTs) during pregnancy. Current reports and studies are limited in their usefulness, mostly by small sample size. Branded glatiramer acetate (GA) is a DMT approved for the treatment of relapsing forms of MS. For more than 2 decades, it has been shown to be efficacious and to have a favorable safety profile. The Teva Pharmaceutical Industries Ltd global pharmacovigilance database comprises data from more than 7000 pregnancies, during which women with MS were exposed to treatment with branded GA. Methods: We analyzed data from Teva's global pharmacovigilance database. Pregnancy outcomes for patients treated with branded GA were compared with reference rates of abnormal pregnancy outcomes reported in two large registries representing the general population. Results: Pregnancies exposed to branded GA were not at higher risk for congenital anomalies than what is expected in the general population. Conclusions: These data provide evidence that branded GA exposure during pregnancy seems safe, without teratogenic effect.</p>},
  author       = {Sandberg-Wollheim, Magnhild and Neudorfer, Orit and Grinspan, Augusto and Weinstock-Guttman, Bianca and Haas, Judith and Izquierdo, Guillermo and Riley, Claire and Ross, Amy Perrin and Baruch, Peleg and Drillman, Talya and Coyle, Patricia K.},
  issn         = {1537-2073},
  language     = {eng},
  number       = {1},
  pages        = {9--14},
  publisher    = {Igitur publishing},
  series       = {International Journal of MS Care},
  title        = {Pregnancy outcomes from the Branded glatiramer acetate pregnancy database},
  url          = {http://dx.doi.org/10.7224/1537-2073.2016-079},
  volume       = {20},
  year         = {2018},
}