ECTRIMS eLearning

A review of observational studies of women with MS and pregnancy
Author(s): ,
M.K Houtchens
Affiliations:
Brigham and Women's Hospital, Harvard Medical School, Brookline
,
N.C Edwards
Affiliations:
Health Services Consulting Corporation, Boxborough
A.L Phillips
Affiliations:
EMD Serono, Inc., Rockland, MA, United States
ECTRIMS Learn. Houtchens M. 09/16/16; 146701; P861
Maria K. Houtchens
Maria K. Houtchens
Contributions
Abstract

Abstract: P861

Type: Poster

Abstract Category: Clinical aspects of MS - MS and gender

Introduction: Real-world evidence involves patient healthcare data collected outside of the randomised controlled trial environment to provide information on relevant health outcomes in a real-world setting reflective of clinical practice in a large number of patients. This evidence provides insights into unmet needs, interventional pathways, and the clinical impact on patients and the healthcare systems involved. An understanding of the outcomes of women with multiple sclerosis (MS) and pregnancy is essential to improve available clinical support, healthcare services, and quality of life for women with MS of childbearing age. The objective of this study was to conduct a literature review to identify and summarize the observational studies (i.e. prospective cohort studies, retrospective chart reviews, population-based surveys, observational registries, retrospective database evaluations, etc.) that have reported on the outcomes of women with MS and pregnancy.

Methods: We conducted a search of peer-reviewed observational studies for women with MS and pregnancy using the MEDLINE (PubMed) database. Search terms used were "multiple sclerosis" AND "pregnancy" AND ("observational" OR "cohort" OR "retrospective" OR "survey" OR "registry" OR "database"). Articles were restricted to those published after the year 2000. Reference lists of selected studies were also reviewed for additional literature.

Results: The literature review found that there was a paucity of observational studies reporting real-world outcomes in women with MS and pregnancy (n=39). Approximately half of the studies (n=20) reported on the impact of a specific treatment in MS. Because patients" therapy can vary with time, it is important to understand the outcomes of all women with MS who have pregnancy. Only 19 publications considered all women with MS who have a pregnancy, irrespective of treatment. Nine studies were conducted in Europe, four were from Canada, two each were from the United States and South America, and one each were from Russia and Taiwan. Most evaluated delivery and birth outcomes (n=11), five evaluated outcomes during pregnancy, and four evaluated the impact of pregnancy on MS.

Conclusions:
As the demand for evidence to support decision making in women with MS of childbearing age escalates, more data from large observational studies are needed. These studies can provide information about outcomes from large numbers of patients treated in a variety of practice settings.

Disclosure: Maria K Houtchens received grant support from EMD Serono, Inc.

Natalie C Edwards is an employee of Health Services Consulting Corporation. Health Services Consulting Corporation received funding from EMD Serono, Inc., to run the analysis.

Amy L Phillips is an employee of EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany).

Abstract: P861

Type: Poster

Abstract Category: Clinical aspects of MS - MS and gender

Introduction: Real-world evidence involves patient healthcare data collected outside of the randomised controlled trial environment to provide information on relevant health outcomes in a real-world setting reflective of clinical practice in a large number of patients. This evidence provides insights into unmet needs, interventional pathways, and the clinical impact on patients and the healthcare systems involved. An understanding of the outcomes of women with multiple sclerosis (MS) and pregnancy is essential to improve available clinical support, healthcare services, and quality of life for women with MS of childbearing age. The objective of this study was to conduct a literature review to identify and summarize the observational studies (i.e. prospective cohort studies, retrospective chart reviews, population-based surveys, observational registries, retrospective database evaluations, etc.) that have reported on the outcomes of women with MS and pregnancy.

Methods: We conducted a search of peer-reviewed observational studies for women with MS and pregnancy using the MEDLINE (PubMed) database. Search terms used were "multiple sclerosis" AND "pregnancy" AND ("observational" OR "cohort" OR "retrospective" OR "survey" OR "registry" OR "database"). Articles were restricted to those published after the year 2000. Reference lists of selected studies were also reviewed for additional literature.

Results: The literature review found that there was a paucity of observational studies reporting real-world outcomes in women with MS and pregnancy (n=39). Approximately half of the studies (n=20) reported on the impact of a specific treatment in MS. Because patients" therapy can vary with time, it is important to understand the outcomes of all women with MS who have pregnancy. Only 19 publications considered all women with MS who have a pregnancy, irrespective of treatment. Nine studies were conducted in Europe, four were from Canada, two each were from the United States and South America, and one each were from Russia and Taiwan. Most evaluated delivery and birth outcomes (n=11), five evaluated outcomes during pregnancy, and four evaluated the impact of pregnancy on MS.

Conclusions:
As the demand for evidence to support decision making in women with MS of childbearing age escalates, more data from large observational studies are needed. These studies can provide information about outcomes from large numbers of patients treated in a variety of practice settings.

Disclosure: Maria K Houtchens received grant support from EMD Serono, Inc.

Natalie C Edwards is an employee of Health Services Consulting Corporation. Health Services Consulting Corporation received funding from EMD Serono, Inc., to run the analysis.

Amy L Phillips is an employee of EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany).

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