Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry.
Abnormalities, Drug-Induced
/ epidemiology
Abortion, Spontaneous
/ chemically induced
Adult
Congenital Abnormalities
/ epidemiology
Europe
/ epidemiology
Female
Humans
Immunologic Factors
/ adverse effects
Infant, Newborn
Interferon-beta
/ adverse effects
Multiple Sclerosis
/ drug therapy
Pregnancy
Pregnancy Complications
/ drug therapy
Pregnancy Outcome
/ epidemiology
Prospective Studies
Registries
Congenital anomalies
Disease-modifying drugs
Interferon-beta
Multiple sclerosis
Pregnancy
Spontaneous abortions
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
14
10
2019
accepted:
12
02
2020
revised:
11
02
2020
pubmed:
27
2
2020
medline:
18
3
2021
entrez:
27
2
2020
Statut:
ppublish
Résumé
Family planning is an important consideration for women with multiple sclerosis (MS), who are often diagnosed during their reproductive years. Currently, limited data are available on pregnancy outcomes in patients exposed to interferon-beta (IFN-beta) before or during pregnancy. Here, we present the cumulative pregnancy exposure data and prevalence of pregnancy and infant outcomes in IFN-beta-exposed pregnant women with MS from the European IFN-beta Pregnancy Registry. Using spontaneous and solicited reports, the registry collected data from 26 countries of the European Economic Area, consisting of information on women with MS identifying themselves to one of the Marketing Authorisation Holders (Bayer, Biogen, Merck KGaA, and Novartis) or healthcare professionals as pregnant and exposed to IFN-beta during pregnancy or within 1 month before conception. The outcomes collected by the registry included ectopic pregnancies, spontaneous abortions, elective terminations, live, and stillbirths with or without congenital anomalies. The prevalence of pregnancy outcomes was put in context with those reported in the general population. Between 2009 and 2017, the registry collected 948 pregnancy reports with a known pregnancy outcome. Overall, 82.0% (777/948) of pregnancies resulted in live birth without congenital anomaly. When comparing IFN-beta-exposed pregnancies with the general population, the prevalence of spontaneous abortions (10.7% vs. 10-21%) and congenital anomalies in live births (2.1% vs. 2.1-4.1%) were found to be within reported ranges. The data gathered from these pregnancy cases suggest no evidence that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions.
Sections du résumé
BACKGROUND
BACKGROUND
Family planning is an important consideration for women with multiple sclerosis (MS), who are often diagnosed during their reproductive years. Currently, limited data are available on pregnancy outcomes in patients exposed to interferon-beta (IFN-beta) before or during pregnancy. Here, we present the cumulative pregnancy exposure data and prevalence of pregnancy and infant outcomes in IFN-beta-exposed pregnant women with MS from the European IFN-beta Pregnancy Registry.
METHODS
METHODS
Using spontaneous and solicited reports, the registry collected data from 26 countries of the European Economic Area, consisting of information on women with MS identifying themselves to one of the Marketing Authorisation Holders (Bayer, Biogen, Merck KGaA, and Novartis) or healthcare professionals as pregnant and exposed to IFN-beta during pregnancy or within 1 month before conception. The outcomes collected by the registry included ectopic pregnancies, spontaneous abortions, elective terminations, live, and stillbirths with or without congenital anomalies. The prevalence of pregnancy outcomes was put in context with those reported in the general population.
RESULTS
RESULTS
Between 2009 and 2017, the registry collected 948 pregnancy reports with a known pregnancy outcome. Overall, 82.0% (777/948) of pregnancies resulted in live birth without congenital anomaly. When comparing IFN-beta-exposed pregnancies with the general population, the prevalence of spontaneous abortions (10.7% vs. 10-21%) and congenital anomalies in live births (2.1% vs. 2.1-4.1%) were found to be within reported ranges.
CONCLUSIONS
CONCLUSIONS
The data gathered from these pregnancy cases suggest no evidence that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions.
Identifiants
pubmed: 32100126
doi: 10.1007/s00415-020-09762-y
pii: 10.1007/s00415-020-09762-y
pmc: PMC7293672
doi:
Substances chimiques
Immunologic Factors
0
Interferon-beta
77238-31-4
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1715-1723Investigateurs
Metin Akbaba
(M)
Gustavo Borghesi
(G)
Joerg-Peter Bugge
(JP)
Elke Detering
(E)
Evra Köfüncü
(E)
Claudia Luenzmann
(C)
Bettina Mueller
(B)
Axel Olivar
(A)
Kiliana Suzart-Woischnik
(K)
Eva-Maria Wicklein
(EM)
Vanessa Beynon
(V)
Kate Brown
(K)
Nicholas Everage
(N)
Maria Naylor
(M)
Avni Pandhi
(A)
Anh Ly
(A)
Silke Scheller
(S)
Milorad Todorovic
(M)
Dominic Jack
(D)
Yvonne Samsinger
(Y)
Richard Weitzman
(R)
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