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Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Published on Jan 1, 2018in Therapeutic Advances in Neurological Disorders 3.58
· DOI :10.1177/1756286418804760
Yvonne Geissbühler2
Estimated H-index: 2
(Novartis),
Jere Vile1
Estimated H-index: 1
(Novartis)
+ 5 AuthorsKerstin Hellwig30
Estimated H-index: 30
(RUB: Ruhr University Bochum)
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Abstract
Background and Methods:Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.Results:The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.Conclusions:These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.
  • References (16)
  • Citations (1)
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References16
Newest
Published on Dec 1, 2016in BMC Neurology 2.23
Susan Friend1
Estimated H-index: 1
(Biogen Idec),
Sandra Richman11
Estimated H-index: 11
(Biogen Idec)
+ 2 AuthorsMadé Wenten5
Estimated H-index: 5
(Biogen Idec)
Background Patients with multiple sclerosis (MS) or Crohn’s disease (CD) being treated with natalizumab (Tysabri®, Biogen) who are planning to become pregnant or discover they are pregnant after exposure to natalizumab are currently advised to balance the potential benefits and potential risks of exposure when considering treatment options. This study was undertaken to evaluate pregnancy outcomes of women with MS or CD who were exposed to natalizumab at any time within 3 months prior to concepti...
Published on May 1, 2016in Multiple Sclerosis Journal 5.65
Sandra Herbstritt4
Estimated H-index: 4
(HHU: University of Düsseldorf),
Annette Langer-Gould25
Estimated H-index: 25
(KP: Kaiser Permanente)
+ 4 AuthorsKerstin Hellwig30
Estimated H-index: 30
(RUB: Ruhr University Bochum)
Background:Only limited data are available on whether glatiramer acetate exposure during pregnancy has an effect on perinatal outcome.Objective:To determine the effect of glatiramer acetate exposure during pregnancy on pregnancy outcomes in women with multiple sclerosis.Methods: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 P...
Published on May 1, 2016in Multiple Sclerosis Journal 5.65
Sandra Thiel1
Estimated H-index: 1
(HHU: University of Düsseldorf),
Annette Langer-Gould25
Estimated H-index: 25
(KP: Kaiser Permanente)
+ 4 AuthorsKerstin Hellwig30
Estimated H-index: 30
(RUB: Ruhr University Bochum)
Background:Available data suggest that pregnancy exposure to interferon-beta might result in lower mean birth weight and preterm birth.Objective:To determine the effect of interferon-beta exposure during pregnancy on pregnancy outcomes in multiple sclerosis patients.Methods:We compared the pregnancy outcomes of women exposed to interferon-beta with pregnancies unexposed to disease-modifying therapies. Women were enrolled into the German Multiple Sclerosis and Pregnancy Registry. A standardized q...
Published on Feb 1, 2015in Pediatrics and Neonatology 1.50
Alexander Egbe6
Estimated H-index: 6
(Mount Sinai Hospital),
Santosh Uppu6
Estimated H-index: 6
(Mount Sinai Hospital)
+ 3 AuthorsShubhika Srivastava18
Estimated H-index: 18
(Mount Sinai Hospital)
Background Congenital malformation (CM) is a leading cause of infant mortality. We hypothesized that the current estimates of the prevalence of CM are obsolete because of the increased rate of terminating fetuses with severe CMs and the widespread use of prenatal vitamins. Methods This population-based cross-sectional study analyzed the effect of sex and prematurity on CM prevalence. All data were derived from birth entries in the 2008 Nationwide Inpatient Sample (NIS) database. Our objectives w...
Published on Feb 1, 2015in Multiple Sclerosis Journal 5.65
Neda Ebrahimi4
Estimated H-index: 4
(U of T: University of Toronto),
Sandra Herbstritt4
Estimated H-index: 4
(RUB: Ruhr University Bochum)
+ 3 AuthorsKerstin Hellwig30
Estimated H-index: 30
(RUB: Ruhr University Bochum)
Background:Safety data on first-trimester natalizumab exposure are scarce, as natalizumab is usually withdrawn three months before pregnancy.Objective:The objective of this paper is to investigate the fetal safety of exposure to natalizumab (Tysabri®) during the first trimester of pregnancy using disease-matched (DM) and healthy control (HC) comparison groups.Methods:A total of 101 German women with RRMS exposed to natalizumab during the first trimester of pregnancy were identified. Birth outcom...
Published on Aug 1, 2011in Multiple Sclerosis Journal 5.65
Kerstin Hellwig30
Estimated H-index: 30
(RUB: Ruhr University Bochum),
Aiden Haghikia27
Estimated H-index: 27
(RUB: Ruhr University Bochum),
R. Gold73
Estimated H-index: 73
(RUB: Ruhr University Bochum)
Background: Natalizumab, a therapeutic monoclonal antibody approved for the treatment of relapsing–remitting multiple sclerosis (RRMS), is recommended to be withdrawn 3 months prior to a planned pregnancy. Our aim was to analyse the safety and impact of natalizumab exposure on course of disease and pregnancy outcome.Objectives: Prospective follow-up of women with MS who became accidentally pregnant during natalizumab treatment in comparison with pregnancies of women with MS not exposed to diseas...
Samantha E. Parker12
Estimated H-index: 12
(CDC: Centers for Disease Control and Prevention),
Cara T. Mai17
Estimated H-index: 17
(CDC: Centers for Disease Control and Prevention)
+ 8 AuthorsRussell S. Kirby53
Estimated H-index: 53
(USF: University of South Florida)
BACKGROUND: The National Birth Defects Prevention Network collects state-specific birth defects surveillance data for annual publication of prevalence estimates and collaborative research projects. In 2006, data for 21 birth defects from 1999 through 2001 were presented as national birth prevalence estimates. The purpose of this report was to update these estimates using data from 2004 through 2006. METHODS: Population-based data from 11 active case-finding programs, 6 passive case-finding progr...
Published on Sep 1, 2009in Multiple Sclerosis Journal 5.65
C Weber-Schoendorfer1
Estimated H-index: 1
,
Christof Schaefer20
Estimated H-index: 20
BackgroundThere is still uncertainty about the management of pregnant women exposed to immunomodulatory therapy for treatment of multiple sclerosis (MS) in pregnancy.ObjectiveTo assess the safety of interferon (IFN)-β1a, IFN-β1b, and glatiramer acetate (GA) for treatment of MS during pregnancy.MethodsA prospective observational cohort study was performed with patients enrolled through a drug risk assessment by the Teratology Information Service (TIS), Berlin, from 1996 to 2007. Pregnancy outcome...
Published on Jan 1, 2009in Paediatric and Perinatal Epidemiology 2.68
Payam Dadvand34
Estimated H-index: 34
(Newcastle University),
Judith Rankin45
Estimated H-index: 45
+ 2 AuthorsTanja Pless-Mulloli16
Estimated H-index: 16
Summary Congenital heart disease (CHD) is the most prevalent group of congenital anomalies. There is considerable variation in the reported epidemiology of CHD, mainly attributable to methodological differences. Using register-based data, the current study describes the epidemiology of CHD in a geographically well-defined population of the North of England during 1985–2003. The total prevalence of CHD was 85.9 per 10 000 births and terminations of pregnancy for fetal anomaly. Livebirth prevalenc...
Published on Sep 1, 2008in Biochimica et Biophysica Acta 3.79
Mari Kono21
Estimated H-index: 21
(NIH: National Institutes of Health),
Maria L. Allende19
Estimated H-index: 19
(NIH: National Institutes of Health),
Richard L. Proia68
Estimated H-index: 68
(NIH: National Institutes of Health)
Sphingosine-1-phosphate (S1P) was first identified as a lysophospholipid metabolite whose formation is required for the irreversible degradation of sphingolipids. Years later, it was discovered that S1P is a bioactive lipid that provokes varied cell responses by acting through cell-surface receptors to drive cell signaling. More recent findings in model organisms have now established that S1P metabolism and signaling are integrated into many physiological systems. We describe here the surprising...
Cited By1
Newest
Published on Jul 19, 2019
A. I. Ciplea , S. Thiel + 1 AuthorsKerstin Hellwig30
Estimated H-index: 30
Published on Apr 19, 2019in Biomedicines
Multiple sclerosis (MS) primarily affects women in childbearing age and is associated with an increased risk of adverse post-partum outcomes. Relapses and now fetal exposure to disease modifying treatments in the early phase of pregnancy and thereafter are of concern. Safe and effective contraception is required for women who wish to delay or avoid pregnancy while on disease-modifying treatments. Counseling and planning is essential to assess the risk of both fetal and maternal complications, pa...