Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series.
BACKGROUND
Glatiramer acetate is a US FDA category B drug with regard to use by pregnant women with multiple sclerosis (MS). There are no data currently available for the continuous use of glatiramer acetate during pregnancy.


OBJECTIVE
To assess the risks and benefits of glatiramer acetate used throughout pregnancy among women with active MS.


METHODS
Retrospective and multicentre case series.


METHODS
Outpatient services of academic and private institutions caring for patients with MS in Brazil.


METHODS
Eleven women with MS and their children were assessed.


METHODS
Retrospective evaluation of women with MS who received glatiramer acetate continuously for at least 7 months during pregnancy. This evaluation was performed by the neurologist responsible for the patient. Children aged 1 year and over, born to mothers who received glatiramer acetate during pregnancy, were assessed using the Denver II developmental screening test.


METHODS
Obstetric, neonatal and developmental outcomes.


RESULTS
No drug-related obstetric complications were observed. No specific drug-related malformations, neonatal complications or developmental abnormalities were observed in the children. Postnatal MS relapse rates remained significantly lower than antenatal rates in these patients.


CONCLUSIONS
No deleterious effects from glatiramer acetate were observed in these pregnant women with MS or in their offspring. No increment in postnatal relapse rate was observed. However, the use of glatiramer acetate during pregnancy should be restricted to the most difficult cases, in which the benefits clearly outweigh the risks.
Fragoso
Yára D
YD
Department of Neurology, Universidade Metropolitana de Santos and Departamento Regional de Saúde IV, Santos, Sao Paulo, Brazil. yara@bsnet.com.br
Finkelsztejn
Alessandro
A
Kaimen-Maciel
Damacio R
DR
Grzesiuk
Anderson K
AK
Gallina
Andre S
AS
Lopes
Josiane
J
Morales
Nivea M O
NM
Alves-Leon
Soniza V
SV
de Almeida
Sandra M G
SM
D000293:Adolescent; D000328:Adult; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D010455:Peptides / Q000009:adverse effects* / Q000627:therapeutic use*; D011247:Pregnancy; D012189:Retrospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate
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