Prevalence of infant outcomes at birth after exposure to interferon beta prior to or during pregnancy: a register-based cohort study in Finland and Sweden among women with MS
ECTRIMS Online Library. Korhonen P. 09/13/19; 278346; P1144
Pasi Korhonen
Pasi Korhonen
Contributions
Abstract

Abstract: P1144

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

P. Vattulainen1, S. Burkill2, Y. Geissbuehler3, M. Sabidó4, C. Popescu5, K. Suzart-Woischnik6, K.-M. Myhr7, S. Montgomery2,8,9, P. Korhonen1, European Interferon Beta Pregnancy Study Group, Nordic MS Pregnancy & Interferon Beta Study Group

1StatFinn and EPID Research (an IQVIA Company), Espoo, Finland, 2Karolinska Institute, Stockholm, Sweden, 3Novartis Pharma AG, Basel, Switzerland, 4Merck KGaA, Darmstadt, Germany, 5Biogen Ltd, Maidenhead, United Kingdom, 6Bayer AG, Berlin, Germany, 7Department of Neurology, Haukeland University Hospital, Bergen, Norway, 8Örebro University, Örebro, Sweden, 9University College London, London, United Kingdom

Introduction: Women with multiple sclerosis (MS) are often diagnosed and treated at childbearing age. Systematic reviews and registry studies suggest that MS and interferon-beta (IFNβ) exposure might affect birth weight and head circumference.
Objectives: To determine the prevalence of categorical measures of birth weight for gestational age (small for gestational age (SGA), large for gestational age (LGA)), low birth weight, and low head circumference in IFNβ exposed and unexposed pregnant women with MS from health registers in Finland and Sweden.
Methods: In this cohort study, health register data from Finland (1996-2014) and Sweden (2005-2014) were used to study women with MS 1) dispensed only IFNβ within 6 months prior to date of last menstrual period or during pregnancy (IFNβ-exposed) and 2) without any dispensed MS disease modifying drugs (MSDMDs) (unexposed). The prevalence, with 95% confidence interval (CI), of the following birth outcomes was described for the IFNβ-exposed and the unexposed: SGA, LGA, low birth weight for live births, and low head circumference for infants with full term live birth (at least 37 gestational weeks). For SGA, LGA, and head circumference, national gestational age and sex-specific national references were used. No adjustments for potential confounding factors were performed.
Results: Among 666 IFNβ-exposed and 1330 unexposed live births, the prevalence of the infant outcomes were similar between the IFNβ-exposed vs the unexposed. Comparing the exposed vs unexposed, SGA was 2.1% (95%CI 1.2-3.5) vs 2.0% (95%CI 1.3-2.9), and LGA 0.8% (95%CI 0.2-1.7) vs 0.8% (95%CI 0.4-1.5).The prevalence of low birth weight was 3.9% (95%CI 2.6-5.7) among IFNβ-exposed and 4.8% (95%CI 3.7-6.1) among the unexposed live births. Among 619 IFNβ-exposed and 1219 unexposed full term live births, the prevalence of low head circumference was 1.9% (95%CI 1.0-3.4) among the IFNβ-exposed vs 1.1% (95%CI 0.6-1.8) among the unexposed births.
Conclusions: The data from Finnish and Swedish health registers showed no evidence that IFNβ exposure before and during pregnancy affected infant birth weight and head circumference.
Disclosure: YG is an employee of Novartis Pharma AG
MS is an employee of Merck KGaA, Darmstadt, Germany
CP is an employee and stockholder of Biogen
KS-W is an employee of Bayer AG
PK and PV are employees of StatFinn and EPID Research which performs commissioned pharmacoepidemiological studies for several pharmaceutical companies
K-MM has received unrestricted grants and/or speaker honoraria and/or scientific advisory board honoraria from Almirall, Biogen, Genzyme, Merck, Novartis, Sanofi-Aventis, Roche, Teva and the Norwegian MS Society
SM has received funding for MS research in the last five years from Roche, Novartis, IQVIA and AstraZeneca; and speaker's honoraria, including from Teva
SB is an employee at the Centre for Pharmacoepidemiology, which receive grants from several entities including pharmaceutical companies

Abstract: P1144

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

P. Vattulainen1, S. Burkill2, Y. Geissbuehler3, M. Sabidó4, C. Popescu5, K. Suzart-Woischnik6, K.-M. Myhr7, S. Montgomery2,8,9, P. Korhonen1, European Interferon Beta Pregnancy Study Group, Nordic MS Pregnancy & Interferon Beta Study Group

1StatFinn and EPID Research (an IQVIA Company), Espoo, Finland, 2Karolinska Institute, Stockholm, Sweden, 3Novartis Pharma AG, Basel, Switzerland, 4Merck KGaA, Darmstadt, Germany, 5Biogen Ltd, Maidenhead, United Kingdom, 6Bayer AG, Berlin, Germany, 7Department of Neurology, Haukeland University Hospital, Bergen, Norway, 8Örebro University, Örebro, Sweden, 9University College London, London, United Kingdom

Introduction: Women with multiple sclerosis (MS) are often diagnosed and treated at childbearing age. Systematic reviews and registry studies suggest that MS and interferon-beta (IFNβ) exposure might affect birth weight and head circumference.
Objectives: To determine the prevalence of categorical measures of birth weight for gestational age (small for gestational age (SGA), large for gestational age (LGA)), low birth weight, and low head circumference in IFNβ exposed and unexposed pregnant women with MS from health registers in Finland and Sweden.
Methods: In this cohort study, health register data from Finland (1996-2014) and Sweden (2005-2014) were used to study women with MS 1) dispensed only IFNβ within 6 months prior to date of last menstrual period or during pregnancy (IFNβ-exposed) and 2) without any dispensed MS disease modifying drugs (MSDMDs) (unexposed). The prevalence, with 95% confidence interval (CI), of the following birth outcomes was described for the IFNβ-exposed and the unexposed: SGA, LGA, low birth weight for live births, and low head circumference for infants with full term live birth (at least 37 gestational weeks). For SGA, LGA, and head circumference, national gestational age and sex-specific national references were used. No adjustments for potential confounding factors were performed.
Results: Among 666 IFNβ-exposed and 1330 unexposed live births, the prevalence of the infant outcomes were similar between the IFNβ-exposed vs the unexposed. Comparing the exposed vs unexposed, SGA was 2.1% (95%CI 1.2-3.5) vs 2.0% (95%CI 1.3-2.9), and LGA 0.8% (95%CI 0.2-1.7) vs 0.8% (95%CI 0.4-1.5).The prevalence of low birth weight was 3.9% (95%CI 2.6-5.7) among IFNβ-exposed and 4.8% (95%CI 3.7-6.1) among the unexposed live births. Among 619 IFNβ-exposed and 1219 unexposed full term live births, the prevalence of low head circumference was 1.9% (95%CI 1.0-3.4) among the IFNβ-exposed vs 1.1% (95%CI 0.6-1.8) among the unexposed births.
Conclusions: The data from Finnish and Swedish health registers showed no evidence that IFNβ exposure before and during pregnancy affected infant birth weight and head circumference.
Disclosure: YG is an employee of Novartis Pharma AG
MS is an employee of Merck KGaA, Darmstadt, Germany
CP is an employee and stockholder of Biogen
KS-W is an employee of Bayer AG
PK and PV are employees of StatFinn and EPID Research which performs commissioned pharmacoepidemiological studies for several pharmaceutical companies
K-MM has received unrestricted grants and/or speaker honoraria and/or scientific advisory board honoraria from Almirall, Biogen, Genzyme, Merck, Novartis, Sanofi-Aventis, Roche, Teva and the Norwegian MS Society
SM has received funding for MS research in the last five years from Roche, Novartis, IQVIA and AstraZeneca; and speaker's honoraria, including from Teva
SB is an employee at the Centre for Pharmacoepidemiology, which receive grants from several entities including pharmaceutical companies

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