Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: Stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden.


Journal

Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247

Informations de publication

Date de publication:
Feb 2021
Historique:
received: 14 08 2020
revised: 06 11 2020
accepted: 13 12 2020
pubmed: 12 1 2021
medline: 15 5 2021
entrez: 11 1 2021
Statut: ppublish

Résumé

Previous studies reported no increase in the prevalence of adverse pregnancy outcomes after exposure to interferon-beta (IFN-beta). However, no study has investigated if the prevalence of these outcomes after IFN-beta exposure is modified by maternal and newborn characteristics. Our objective was to describe the stratified prevalence of adverse pregnancy outcomes among women with multiple sclerosis (MS) exposed only to IFN-beta or unexposed to any MS disease modifying drugs (MSDMDs). This population-based cohort study using Finnish (1996-2014) and Swedish (2005-2014) register data included pregnancies of women with MS exposed only to IFN-beta 6 months before or during pregnancy (n=718) or unexposed to MSDMDs (n=1397). The outcome prevalences were described stratified by maternal and newborn characteristics, with 95% confidence intervals (CIs). Confounder-adjusted analyses were performed if the prevalence results indicated modified effect of IFN-beta in specific strata. The stratified analysis indicated that the prevalence of serious (anomaly or stillbirth) and other adverse pregnancy outcomes was similar among the exposed and unexposed, with no statistically significant difference. Among women treated for MS >5 years, serious adverse pregnancy outcomes occurred in 4.3% (95%CI: 1.9-8.3%) of pregnancies exposed only to IFN-beta 6 months before or during pregnancy and in 2.7% (95%CI: 1.2-5.0%) of unexposed pregnancies. The confounder adjusted analyses did not support the hypothesis that MS treatment duration before pregnancy would modify the risk of adverse pregnancy outcomes after exposure to IFN-beta 6 months before or during pregnancy. The prevalence of adverse pregnancy outcomes was not increased after IFN-beta exposure, when pregnancies of women with MS were stratified by maternal and newborn characteristics. The stratified results were similar to the unstratified results in the same population.

Sections du résumé

BACKGROUND BACKGROUND
Previous studies reported no increase in the prevalence of adverse pregnancy outcomes after exposure to interferon-beta (IFN-beta). However, no study has investigated if the prevalence of these outcomes after IFN-beta exposure is modified by maternal and newborn characteristics. Our objective was to describe the stratified prevalence of adverse pregnancy outcomes among women with multiple sclerosis (MS) exposed only to IFN-beta or unexposed to any MS disease modifying drugs (MSDMDs).
METHODS METHODS
This population-based cohort study using Finnish (1996-2014) and Swedish (2005-2014) register data included pregnancies of women with MS exposed only to IFN-beta 6 months before or during pregnancy (n=718) or unexposed to MSDMDs (n=1397). The outcome prevalences were described stratified by maternal and newborn characteristics, with 95% confidence intervals (CIs). Confounder-adjusted analyses were performed if the prevalence results indicated modified effect of IFN-beta in specific strata.
RESULTS RESULTS
The stratified analysis indicated that the prevalence of serious (anomaly or stillbirth) and other adverse pregnancy outcomes was similar among the exposed and unexposed, with no statistically significant difference. Among women treated for MS >5 years, serious adverse pregnancy outcomes occurred in 4.3% (95%CI: 1.9-8.3%) of pregnancies exposed only to IFN-beta 6 months before or during pregnancy and in 2.7% (95%CI: 1.2-5.0%) of unexposed pregnancies. The confounder adjusted analyses did not support the hypothesis that MS treatment duration before pregnancy would modify the risk of adverse pregnancy outcomes after exposure to IFN-beta 6 months before or during pregnancy.
CONCLUSION CONCLUSIONS
The prevalence of adverse pregnancy outcomes was not increased after IFN-beta exposure, when pregnancies of women with MS were stratified by maternal and newborn characteristics. The stratified results were similar to the unstratified results in the same population.

Identifiants

pubmed: 33429303
pii: S2211-0348(20)30768-9
doi: 10.1016/j.msard.2020.102694
pii:
doi:

Substances chimiques

Interferon-beta 77238-31-4

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

102694

Informations de copyright

Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.

Auteurs

Marta Korjagina (M)

StatFinn-EPID Research, Paldiski mnt 29, 10612, Tallinn, Estonia.

Katja M Hakkarainen (KM)

StatFinn-EPID Research, Prästgårdsgatan 28, 431 44 Mölndal, Sweden. Electronic address: katja.hakkarainen@iqvia.com.

Sarah Burkill (S)

Karolinska Institute, Solnavägen 1, 171 77 Solna, Sweden.

Yvonne Geissbühler (Y)

Novartis Pharma AG, Evidence and Launch Excellence, Asklepios 8-3, Postfach, CH-4002 Basel, Switzerland.

Meritxell Sabidó (M)

Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany.

Nicholas Everage (N)

Biogen, 225 Binney Street, Cambridge, MA 02142, United States.

Kiliana Suzart-Woischnik (K)

Bayer AG, Building S102, 148, 13353 Berlin, Germany.

Riho Klement (R)

StatFinn-EPID Research, Narva maantee 3, 51009 Tartu, Estonia.

Jan Hillert (J)

Karolinska Institute, Tomtebodavägen 18A, 171 77 Stockholm, Sweden.

Auli Verkkoniemi-Ahola (A)

Clinical Neurosciences, Neurology, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.

Shahram Bahmanyar (S)

Centre for Pharmacoepidemiology, Department of Medicine, Karolinska Institutet, Solnavägen 1, 171 77 Solna, Sweden; Centre for Psychiatry Research, Karolinska Institutet, Norra Stationsgatan 69, floor 7, 113 64 Stockholm, Sweden; Stockholm Health Care Services, Solnavägen 1 E, Stockholm, Sweden.

Scott Montgomery (S)

Clinical Epidemiology Division, Department of Medicine, Karolinska Institute, Solnavägen 1, 171 77 Solna, Sweden; Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University Hospital and Örebro University, Fakultetsgatan 1, 701 82 Örebro, Sweden; Department of Epidemiology and Public Health, University College London, London, United Kingdom.

Pasi Korhonen (P)

StatFinn-EPID Research, Metsänneidonkuja 6, 02130 Espoo, Finland.

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Classifications MeSH