Contributions
Abstract: P1753
Type: Poster Sessions
Abstract Category: N/A
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 do not adversely affect pregnancy outcomes; however, data on risks of IFNβ exposure during pregnancy are limited. To address this lack of evidence, a European IFNβ pregnancy registry was established and a population-based cohort study was conducted based on data from two Nordic health registers (Finland and Sweden).
Objective: To assess the prevalence of pregnancy and infant outcomes in IFNβ exposed pregnant women with MS from European IFNβ pregnancy registry and Nordic health registers.
Methods: In the European IFNβ pregnancy registry, women identified themselves to the Marketing Authorization Holders (Bayer, Biogen, Merck, Novartis) or healthcare professionals as pregnant and exposed to IFNβ since the first day of the last menstrual period (LMP), shortly before conception, or during pregnancy. In the Nordic countries, data were retrospectively analysed from national health registers recording births. Women treated with IFNβ during pregnancy or within three months prior to LMP were considered as exposed. Pregnancy outcomes collected included congenital anomalies, spontaneous abortions, elective pregnancy terminations, ectopic pregnancies, stillbirths and live births. The prevalence of pregnancy outcomes in women exposed to IFNβ in the European registry are presented alongside the Nordic data, and a cohort of women with an MS diagnosis but unexposed to MS treatment from the Nordic dataset.
Results: A total of 948 and 875 pregnancy reports with exposure to IFNβ and known pregnancy outcomes were collected from the European registry (Eur) and the Nordic registers, respectively. Preliminary analyses showed similar prevalences of spontaneous abortions versus the non-exposed cohort (10.7% Eur; 7.9% Nordic vs. 11.1%) and similar prevalences of live births with congenital anomalies (1.8% Eur; 1.8% Nordic vs. 3.3%) and ectopic pregnancies (0.4% Eur; 1.5% Nordic vs. 2.9%); and are also in line with expected rates from the general population. Additional analyses on pregnancy outcomes will be presented.
Conclusions: The European IFNβ pregnancy registry showed no evidence that IFNβ exposure before conception and/or during pregnancy adversely affected pregnancy or infant outcomes; consistent with data collected from the Nordic registers.
Disclosure: Funding for the analysis, project management and medical writing was provided by Bayer AG, Biogen, Merck KGaA and Novartis Pharma AG.
KH has received honoraria and research support from Bayer, Biogen, Teva, Novartis, Sanofi Genzyme and Merck
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
AA is an employee of Bayer AG
JK is an employee of Synteract GmbH
PH is a member of the European Interferon Beta Pregnancy Study Group
AO has nothing to disclose
PK is an employee 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, and the Norwegian MS Society
SM has received funding for MS research in the last five years from Roche, Novartis 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: P1753
Type: Poster Sessions
Abstract Category: N/A
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 do not adversely affect pregnancy outcomes; however, data on risks of IFNβ exposure during pregnancy are limited. To address this lack of evidence, a European IFNβ pregnancy registry was established and a population-based cohort study was conducted based on data from two Nordic health registers (Finland and Sweden).
Objective: To assess the prevalence of pregnancy and infant outcomes in IFNβ exposed pregnant women with MS from European IFNβ pregnancy registry and Nordic health registers.
Methods: In the European IFNβ pregnancy registry, women identified themselves to the Marketing Authorization Holders (Bayer, Biogen, Merck, Novartis) or healthcare professionals as pregnant and exposed to IFNβ since the first day of the last menstrual period (LMP), shortly before conception, or during pregnancy. In the Nordic countries, data were retrospectively analysed from national health registers recording births. Women treated with IFNβ during pregnancy or within three months prior to LMP were considered as exposed. Pregnancy outcomes collected included congenital anomalies, spontaneous abortions, elective pregnancy terminations, ectopic pregnancies, stillbirths and live births. The prevalence of pregnancy outcomes in women exposed to IFNβ in the European registry are presented alongside the Nordic data, and a cohort of women with an MS diagnosis but unexposed to MS treatment from the Nordic dataset.
Results: A total of 948 and 875 pregnancy reports with exposure to IFNβ and known pregnancy outcomes were collected from the European registry (Eur) and the Nordic registers, respectively. Preliminary analyses showed similar prevalences of spontaneous abortions versus the non-exposed cohort (10.7% Eur; 7.9% Nordic vs. 11.1%) and similar prevalences of live births with congenital anomalies (1.8% Eur; 1.8% Nordic vs. 3.3%) and ectopic pregnancies (0.4% Eur; 1.5% Nordic vs. 2.9%); and are also in line with expected rates from the general population. Additional analyses on pregnancy outcomes will be presented.
Conclusions: The European IFNβ pregnancy registry showed no evidence that IFNβ exposure before conception and/or during pregnancy adversely affected pregnancy or infant outcomes; consistent with data collected from the Nordic registers.
Disclosure: Funding for the analysis, project management and medical writing was provided by Bayer AG, Biogen, Merck KGaA and Novartis Pharma AG.
KH has received honoraria and research support from Bayer, Biogen, Teva, Novartis, Sanofi Genzyme and Merck
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
AA is an employee of Bayer AG
JK is an employee of Synteract GmbH
PH is a member of the European Interferon Beta Pregnancy Study Group
AO has nothing to disclose
PK is an employee 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, and the Norwegian MS Society
SM has received funding for MS research in the last five years from Roche, Novartis 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