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Spotlight Session - Rare Disease

Session: Spotlight Poster Session B

(BSPOT37) Identifying women of childbearing age with Multiple Sclerosis in six European healthcare data sources - A contribution from the IMI-ConcePTION project

Tuesday, August 27, 2024
8:00 AM – 6:00 PM CEST
Location: Foyer 3

    Presenting Author(s)

  • MB

    Marie Beslay, PhD

    Post-doctorant
    CERPOP, Inserm U1295, Université de Toulouse Paul Sabatier, Service de Pharmacologie Clinique, CHU de Toulouse, France

    • Co-Author(s)

  • AB

    Anna-Belle Beau, PhD

    Post-doctoral fellow
    CERPOP, Inserm U1295, Université de Toulouse Paul Sabatier, Service de Pharmacologie Clinique, CHU de Toulouse, France

  • JB

    Justine Bénévent

    CERPOP, Inserm U1295, Université de Toulouse Paul Sabatier, Service de Pharmacologie Clinique, CHU de Toulouse, France

  • EB

    Elisa Ballardini

    Neonatal Intensive Care Unit, University Hospital of Ferrara, IMER Registry (Emilia Romagna Registry of Birth Defects), Department of Medical Sciences, University of Ferrara, Italy, Italy

  • LB

    Laia Barrachina-Bonet

    Rare Disease Research Unit, Foundation for Promotion of Health and Biomedical Research of Valencian Region (FISABIO), Valencia, Spain, Spain

  • CC

    Clara Cavero-Carbonell

    Rare Disease Research Unit, Foundation for Promotion of Health and Biomedical Research of Valencian Region (FISABIO), Valencia, Spain, Spain

  • AC

    Alex Coldea

    Faculty of Medicine, Health and Life Science, Swansea University, Wales, UK, United Kingdom

  • LG

    Laura García-Villodre

    Rare Disease Research Unit, Foundation for Promotion of Health and Biomedical Research of Valencian Region (FISABIO), Valencia, Spain, Spain

  • Rosa Gini, PhD (she/her/hers)

    Head of Unit at ARS Toscana, Florence, Italy
    ARS Toscana, Florence, Italy
    Florence, Italy

  • SH

    Saeed Hayati

    Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway, Norway

  • SJ

    Sue Jordan, MB.BCh., PhD. PGCE (FE),

    professor
    Faculty of Medicine, Health and Life Science, Swansea University, Wales, UK, United Kingdom

  • Maarit K. Leinonen, MD, PhD

    Associate professor
    Knowledge Brokers, Finnish Institute for Health and Welfare; Teratology Information Service, Emergency Medicine and Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
    Helsinki, Finland

  • MM

    Marco Manfrini

    Specialist in health statistics and biometrics
    Department of Medical Sciences, Centre for Clinical and Epidemiological Research, Ferrara University, Italy

  • VM

    Visa Martikainen

    Data manager, statistician
    Knowledge Brokers, Finnish Institute for Health and Welfare, Helsinki, Finland, Finland

  • DM

    Davide Messina

    Programmer
    ARS Toscana, Florence, Italy, Italy

  • VM

    Vera R. Mitter, PhD

    Head of Applied Research Midwifery
    Bern University of Applied Sciences
    Bern, Switzerland

  • AN

    Amanda J. Neville

    Department of Medical Sciences, Centre for Clinical and Epidemiological Research, Emilia Romagna Registry of Birth Defects, Ferrara University, Italy, Italy

  • Hedvig M.E Nordeng, PhD (she/her/hers)

    Professor
    Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo (UiO), Oslo, Norway
    Oslo, Norway

  • DT

    Daniel Thayer

    Faculty of Medicine, Health and Life Science, Swansea University, Wales, UK, United Kingdom

  • JM

    Joan K. Morris

    Professor
    Population Health Research Institute, St George’s, University of London, UK, United Kingdom

  • YG

    Yvonne Geissbühler

    Evidence Generation, Novartis Pharma AG, Basel, Switzerland, Switzerland

  • CD

    Christine Damase-Michel

    CERPOP, Inserm U1295, Université de Toulouse Paul Sabatier, Service de Pharmacologie Clinique, CHU de Toulouse, France

Background: As part of the European ConcePTION project, we aim to assess the safety of Disease Modifying Therapies (DMTs) during pregnancy in women with Multiple Sclerosis (MS). Firstly, women of childbearing age with MS had to be identified within healthcare data sources (DS).

Objectives: To compare 5 different algorithms to identify women of childbearing age with MS, and apply them to estimate the prevalence of MS, in six European healthcare DS.

Methods: The study population included women aged 15 to 49 years between 2005 and 2019 from 6 European DS. Three of the DS (France, Finland and Spain) only collected data during pregnancy periods (from 3 months before to 3 months after pregnancy). All DS provided inpatient diagnoses and medication data, whereas outpatient diagnoses were available in Norway and Finland and primary care diagnoses in Norway, Finland and Wales. We tested 5 algorithms to identify MS: algorithms MS1 to MS3 used both MS-diagnoses and prescriptions/deliveries for MS-DMTs, requiring at least 1, 2, or 3 occurrences, respectively; MS4 and MS5 used only MS-diagnoses (with at least 2 occurrences required for both; MS4 allowed just 1 if it came from inpatient care). MS period prevalence with 95% confidence interval (CI) was estimated in each DS during the study period using the algorithms and stratified by time and age-group.

Results: The number of included women (and the median follow-up) were 1,612,000 (10.5 years) in Norway, 1,371,000 (9.1 years) in Italy, 730,000 (10.7 years) in Wales, 483,000 (2.5 years) in Finland, 189,380 (1.3 years) in Spain, and 103,000 (1.0 year) in France. Based on MS1, the least restrictive algorithm, MS prevalence per 100,000 women (95% CI) ranged from 102 to 456: 102 (84-123) in France, 116 (102-133) in Spain, 236 (223-250) in Finland, 251 (240-263) in Wales, 291 (282-300) in Italy and 456 (446-466) in Norway. Using more restrictive algorithms resulted in a broader disparity in the MS prevalence among the DS: e.g. using MS3 resulted in MS prevalence (95% CI) ranging from 49 (40-60) in Spain to 408 (399-418) in Norway, and MS5 from 18 (12-29) in France to 438 (428-448) in Norway. The prevalence of MS tended to increase with age and calendar time.

Conclusions: The least restrictive algorithm (MS1) most closely approximated the published MS prevalences in the respective countries, which range from 176 per 100,000 women in Spain (2015) [Costa-Arpín et al., 2021] to 473 in Norway (2018) [Willumsen et al., 2020]. Additionally, while geographical variations may contribute to the difference in MS prevalence among the DS, we observed that DS with fewer variables to identify MS and shorter follow-up periods (France and Spain) resulted in a lower MS prevalence compared to DS with more variables available (Finland), longer follow-up (Italy), or both (Wales and Norway).