title: Glatiramer acetate during early pregnancy: A prospective cohort study.
abstract: Only limited data are available on whether glatiramer acetate exposure during pregnancy has an effect on perinatal outcome.
  
  
  
  To determine the effect of glatiramer acetate exposure during pregnancy on pregnancy outcomes in women with multiple sclerosis.
  
  
  
  We compared the outcome of pregnancies of women with multiple sclerosis exposed to glatiramer acetate with pregnancies unexposed to disease-modifying therapies. Women were enrolled into the German Multiple Sclerosis and Pregnancy registry. A standardized questionnaire was administered during pregnancy and postpartum. Detailed information on course of multiple sclerosis and pregnancy, concomitant medications, labor, delivery, and outcome of pregnancy was obtained.
  
  
  
  We collected data on 246 multiple sclerosis pregnancies, 151 exposed to glatiramer acetate and 95 unexposed to disease-modifying therapies during pregnancy. Three (2.2%) congenital anomalies occurred in the exposed and 6 (6.7%) in the control group. We did not observe an increase in other adverse pregnancy or delivery outcomes including spontaneous abortions, preterm birth, Cesarean sections, or reduced birth weight in the exposed group.
  
  
  
  Our data provide further evidence that glatiramer acetate exposure during the first trimester of pregnancy appears safe and without teratogenic effect. These findings provide important additive knowledge to better counsel women with multiple sclerosis in planning a pregnancy.
authors.affiliation: Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany/Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Duesseldorf, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Herbstritt
authors.affiliation: Kaiser Permanente Southern California, Pasadena, CA, USA.
authors.forename: Annette
authors.initials: A
authors.lastname: Langer-Gould
authors.affiliation: Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.
authors.forename: Milena
authors.initials: M
authors.lastname: Rockhoff
authors.affiliation: Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.
authors.forename: Aiden
authors.initials: A
authors.lastname: Haghikia
authors.affiliation: Centre of Paediatrics and Youth Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Queisser-Wahrendorf
authors.affiliation: Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Gold
authors.affiliation: Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Gudrunstrasse 56, 44791 Bochum, Germany k.hellwig@klinikum-bochum.de.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Hellwig
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000022:Abortion, Spontaneous / Q000139:chemically induced* / Q000453:epidemiology; D000328:Adult; D001724:Birth Weight / Q000187:drug effects*; D002585:Cesarean Section / Q000706:statistics & numerical data; D005260:Female; D005858:Germany / Q000453:epidemiology; D000068717:Glatiramer Acetate / Q000009:adverse effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007231:Infant, Newborn; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000453:epidemiology; D047928:Premature Birth / Q000139:chemically induced* / Q000453:epidemiology; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data*
chemical_list: D007166:Immunosuppressive Agents; D000068717:Glatiramer Acetate
keywords: Multiple sclerosis; disease-modifying therapies; glatiramer acetate; pregnancy; pregnancy outcomes; safety