Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
Overview
- Phase
- Not Applicable
- Intervention
- Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
- Conditions
- Multiple Sclerosis
- Sponsor
- Bayer
- Enrollment
- 2089
- Locations
- 1
- Primary Endpoint
- Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
Detailed Description
Information will be obtained from the Drugs and Pregnancy Project database (DPP - FIN) and the Medical Birth Register (MBR - SWE, NOR). The Finnish DPP and Norwegian MBR include information on all stillbirths of foetuses with a birth weight of at least 500 g or with a gestational age of at least 22+0 Gestational Week (GW). The Swedish MBR includes data on stillbirths after 28 GW The estimated number of pregnancies in MS patients needed is 1671, encompassing data from: i) FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR: 1 January 2004 - 31 December 2014.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
Exclusion Criteria
- Not provided
Arms & Interventions
IFN-β / Cohort 1
Exposure to IFN-β only
Intervention: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
IFN-β / Cohort 1
Exposure to IFN-β only
Intervention: Extavia (interferon beta-1b), Novartis Pharma AG
IFN-β / Cohort 1
Exposure to IFN-β only
Intervention: Rebif (interferon beta-1a), Merck Serono Europe Ltd
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
Intervention: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
IFN-β / Cohort 1
Exposure to IFN-β only
Intervention: Plegridy (peginterferon beta-1a), Biogen Idec Ltd
IFN-β / Cohort 1
Exposure to IFN-β only
Intervention: Avonex (interferon beta-1a), Biogen Idec Ltd
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
Intervention: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
Intervention: Extavia (interferon beta-1b), Novartis Pharma AG
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
Intervention: Rebif (interferon beta-1a), Merck Serono Europe Ltd
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
Intervention: Avonex (interferon beta-1a), Biogen Idec Ltd
No MSDMDs / Cohort 3
Women with MS exposed with no exposure to any MSDMDs
Intervention: No MSDMDs therapy (control)
No IFN-β + other MSDMDs / Cohort 4
Women with MS exposed to IFN-β exposure regardless of exposure to other MSDMDs
Intervention: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Other MSDMDs / Cohort 5
Women with MS exposed to other MSDMD only excluding IFN-β or glatiramer acetate (Copaxone) or dimethyl fumarate (Tecfidera)
Intervention: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Outcomes
Primary Outcomes
Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Elective TOPFA for other reasons than IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Elective termination for other reasonsthan IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Stillbirth due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Live birth while different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of live birth due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of MCA due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
MCA due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure
Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Secondary Outcomes
- Prevalence of stillbirth stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Prevalence of live birth stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Prevalence of MCA stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Prevalence of elective TOPFA stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)