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      Pregnancy rates and outcomes in women with and without MS in the United States

      research-article
      , MD , , MSc, , ScD, , BA, , PharmD
      Neurology
      Lippincott Williams & Wilkins

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          Abstract

          Objective

          To compare pregnancy prevalence and complications in women with and without multiple sclerosis (MS).

          Methods

          This retrospective US administrative claims study used data from January 1, 2006, to June 30, 2015. All data for women with MS were included. A nationally representative 5% random sample from approximately 58 million women without MS was used to compute the dataset. Annual pregnancy rates, identified via diagnosis/procedure codes and adjusted for covariates, were estimated via logistic regression. Claims for pregnancy and labor/delivery complications were compared using propensity score matching.

          Results

          From 2006 to 2014, the adjusted proportion of women with MS and pregnancy increased from 7.91% to 9.47%; the adjusted proportion without MS and with pregnancy decreased from 8.83% to 7.75%. The difference in linear trend (0.17% increase and 0.15% decrease in per-annum pregnancy rates) was significant ( t statistic = 7.8; p < 0.0001). After matching (n = 2,115 per group), a higher proportion of women with MS than without had claims for premature labor (31.4% vs 27.4%; p = 0.005), infection (13.3% vs 10.9%; p = 0.016), cardiovascular disease (3.0% vs 1.9%; p = 0.028), anemia/acquired coagulation disorders (2.5% vs 1.3%; p = 0.007), neurologic complications (1.6% vs 0.6%; p = 0.005), sexually transmitted diseases (0.4% vs 0.1%; p = 0.045), acquired fetal damage (27.8% vs 23.5%; p = 0.002), and congenital fetal malformations (13.2% vs 10.3%; p = 0.004).

          Conclusions

          Pregnancy rates in this population of women with MS have been increasing. High rates of claims for several peripartum complications were observed in women with and those without MS. Claims data provide knowledge of interactions patients have with the health care system and are valuable initial exploratory analyses.

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          Most cited references28

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          Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005.

          (2008)
          Major structural or genetic birth defects affect approximately 3% of births in the United States, are a major contributor to infant mortality, and result in billions of dollars in costs for care. Although the causes of most major birth defects are unknown, concerns have been raised that certain factors, such as an increase in the prevalence of diabetes among women, might result in increased prevalence of birth defects over time. This report updates previously published data from the Metropolitan Atlanta Congenital Defects Program (MACDP), the oldest population-based birth defects surveillance system in the United States with active case ascertainment. For the period 1978-2005, CDC assessed the overall prevalence of major birth defects and their frequency relative to selected maternal and infant characteristics. The MACDP results indicated that the prevalence of major birth defects in metropolitan Atlanta, Georgia, remained stable during 1978-2005 but varied by maternal age and race/ethnicity, birthweight, and gestational age. Tracking the overall prevalence of major birth defects can identify subgroups that are affected disproportionately; additional measures focused on these subgroups might improve preconception care and care during pregnancy to prevent birth defects.
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            Pregnancy is associated with a lower risk of onset and a better prognosis in multiple sclerosis.

            The effects of pregnancy were studied in a multiple sclerosis incidence cohort. In order to eliminate interaction bias between the disease and pregnancy, analysis of the risk of relapse during pregnancy and the puerperium was limited to the onset bout, using fecundity figures for Sweden. The risk of onset bout was significantly reduced during pregnancy while the risk of onset bout in the post-partum period did not differ significantly from the risk during non-pregnancy periods. We also found a decreased risk of multiple sclerosis onset in parous compared with nulliparous women. The association between nulliparity and multiple sclerosis tended to increase with age. Furthermore, the effect of pregnancy on the long-term prognosis in established multiple sclerosis was analysed by comparing the risk of change from a relapsing-remitting to a chronic progressive course and the risk of reaching level 6 of the Disability Status Scale in women with pregnancy after multiple sclerosis onset with that in non-pregnant control patients, matched for neurological deficit, disease duration and age. There was a significantly decreased risk of a progressive course in women who were pregnant after multiple sclerosis onset.
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              Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development.

              Comparative-effectiveness research (CER) aims to produce actionable evidence regarding the effectiveness and safety of medical products and interventions as they are used outside of controlled research settings. Although CER evidence regarding medications is particularly needed shortly after market approval, key methodological challenges include (i) potential bias due to channeling of patients to the newly marketed medication because of various patient-, physician-, and system-related factors; (ii) rapid changes in the characteristics of the user population during the early phase of marketing; and (iii) lack of timely data and the often small number of users in the first few months of marketing. We propose a mix of approaches to generate comparative-effectiveness data in the early marketing period, including sequential cohort monitoring with secondary health-care data and propensity score (PS) balancing, as well as extended follow-up of phase III and phase IV trials, indirect comparisons of placebo-controlled trials, and modeling and simulation of virtual trials.
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                Author and article information

                Contributors
                Journal
                Neurology
                Neurology
                neurology
                neur
                neurology
                NEUROLOGY
                Neurology
                Lippincott Williams & Wilkins (Hagerstown, MD )
                0028-3878
                1526-632X
                23 October 2018
                23 October 2018
                : 91
                : 17
                : e1559-e1569
                Affiliations
                From the Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston; Health Services Consulting Corporation (N.C.E.), Boxborough; formerly with Boston Health Economics, Inc. (G.S.), Waltham; Boston Health Economics (K.S.), Waltham; and EMD Serono, Inc. (A.L.P.), Rockland, MA.
                Author notes
                Correspondence Dr. Houtchens mhoutchens@ 123456bwh.harvard.edu

                Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

                The Article Processing Charge was funded by EMD Serono, Inc., Rockland, MA (a business of Merck KGaA, Darmstadt, Germany).

                Article
                NEUROLOGY2017870345
                10.1212/WNL.0000000000006384
                6205683
                30266889
                f08dcace-907f-46d2-b5d2-f3c8df4d821f
                Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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