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  1. Artikel ; Online: A comparison of clinical outcomes in PPMS in the INFORMS original trial data set.

    Koch, Marcus W / Mostert, Jop P / Uitdehaag, Bernard / Cutter, Gary

    Multiple sclerosis (Houndmills, Basingstoke, England)

    2021  Band 27, Heft 12, Seite(n) 1864–1874

    Abstract: Background: The expanded disability status scale (EDSS) is the standard clinical outcome measure in primary progressive multiple sclerosis (PPMS), even though the timed 25-foot walk (T25FW), nine-hole peg test (NHPT) or combinations of these measures ... ...

    Abstract Background: The expanded disability status scale (EDSS) is the standard clinical outcome measure in primary progressive multiple sclerosis (PPMS), even though the timed 25-foot walk (T25FW), nine-hole peg test (NHPT) or combinations of these measures may be more useful. The paced auditory serial addition test (PASAT) is a widely used cognitive measure in MS, but little is known about change in PASAT scores over time in PPMS.
    Objective: The objective of this study is to compare clinical outcome measures in a large PPMS trial data set.
    Methods: We determined significant worsening events on the EDSS, T25FW and NHPT, and PASAT scores over the course of this 3-year trial. We compared unconfirmed, confirmed and sustained disability worsening and contrasted disability worsening with similarly defined improvement. We examined the association of baseline characteristics with the risk of disability worsening at 12, 24 and 36 months with logistic regression models.
    Results: The EDSS and T25FW showed most worsening events, while only few patients worsened on the NHPT. Adding the NHPT to a combined outcome added only few further worsening events. PASAT scores slightly increased over time, possibly due to a practice effect.
    Conclusion: Both the EDSS and T25FW, but not NHPT or PASAT, appear to be useful outcome measures in PPMS.
    Mesh-Begriff(e) Disability Evaluation ; Disabled Persons ; Humans ; Multiple Sclerosis, Chronic Progressive/diagnosis ; Outcome Assessment, Health Care ; Walking
    Sprache Englisch
    Erscheinungsdatum 2021-01-19
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458520987539
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Response to Grech et al.: FLOUX-PMS study sample considerations.

    Mostert, Jop P / De Keyser, Jacques

    Multiple sclerosis (Houndmills, Basingstoke, England)

    2019  Band 25, Heft 13, Seite(n) 1820–1821

    Mesh-Begriff(e) Demyelinating Diseases ; Fluoxetine ; Humans ; Multiple Sclerosis
    Chemische Substanzen Fluoxetine (01K63SUP8D)
    Sprache Englisch
    Erscheinungsdatum 2019-09-20
    Erscheinungsland England
    Dokumenttyp Journal Article ; Comment
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458519876027
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  3. Artikel ; Online: COVID-19 in multiple sclerosis: The Dutch experience.

    Loonstra, Floor C / Hoitsma, Elske / van Kempen, Zoé LE / Killestein, Joep / Mostert, Jop P

    Multiple sclerosis (Houndmills, Basingstoke, England)

    2020  Band 26, Heft 10, Seite(n) 1256–1260

    Abstract: Here, we provide an extensive overview of all reported COVID-19 cases in multiple sclerosis (MS) patients in the Netherlands between 27 February and 9 June 2020, gathered by the Dutch MS Taskforce of the Netherlands Society of Neurology. A total of 86 MS ...

    Abstract Here, we provide an extensive overview of all reported COVID-19 cases in multiple sclerosis (MS) patients in the Netherlands between 27 February and 9 June 2020, gathered by the Dutch MS Taskforce of the Netherlands Society of Neurology. A total of 86 MS patients were reported, 43 of whom tested positive for COVID-19. Of 43 patients who tested positive, 22 patients were hospitalized. Three intensive care unit (ICU) admissions and four deaths were reported. Our findings show no apparent difference in disease-modifying treatment (DMT) use and COVID-19 disease course in Dutch MS patients. In addition, a clear link between low lymphocyte count and severe disease was not observed.
    Mesh-Begriff(e) Adult ; Aged ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/blood ; Coronavirus Infections/epidemiology ; Coronavirus Infections/mortality ; Coronavirus Infections/physiopathology ; Female ; Hospitalization/statistics & numerical data ; Humans ; Immunologic Factors/therapeutic use ; Intensive Care Units ; Lymphocyte Count ; Lymphopenia/blood ; Lymphopenia/epidemiology ; Male ; Middle Aged ; Multiple Sclerosis/drug therapy ; Multiple Sclerosis/epidemiology ; Netherlands/epidemiology ; Pandemics ; Pneumonia, Viral/blood ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/mortality ; Pneumonia, Viral/physiopathology ; SARS-CoV-2 ; Severity of Illness Index ; Young Adult
    Chemische Substanzen Immunologic Factors
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2020-07-14
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458520942198
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Comparison of the EDSS, Timed 25-Foot Walk, and the 9-Hole Peg Test as Clinical Trial Outcomes in Relapsing-Remitting Multiple Sclerosis.

    Koch, Marcus W / Mostert, Jop P / Wolinsky, Jerry S / Lublin, Fred D / Uitdehaag, Bernard / Cutter, Gary R

    Neurology

    2021  Band 97, Heft 16, Seite(n) e1560–e1570

    Abstract: Background and objectives: Clinical trials in relapsing-remitting multiple sclerosis (RRMS) usually use the Expanded Disability Status Scale (EDSS) as their primary disability outcome measure, while the more recently developed outcomes timed 25-ft walk ( ...

    Abstract Background and objectives: Clinical trials in relapsing-remitting multiple sclerosis (RRMS) usually use the Expanded Disability Status Scale (EDSS) as their primary disability outcome measure, while the more recently developed outcomes timed 25-ft walk (T25FW) and 9-hole peg test (NHPT) may be more useful and patient relevant. The objective of this work was to compare the EDSS to the T25FW and NHPT in a large RRMS randomized controlled trial (RCT) dataset.
    Methods: We used the dataset from Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) (clinicaltrials.gov identifier NCT00211887), a large phase 3 RCT, to compare the EDSS to the alternative outcomes T25FW and NHPT. We investigated disability worsening vs similarly defined improvement, unconfirmed vs confirmed and sustained disability change, and the presentation methods cumulative Kaplan-Meier survival curves vs cross-sectional disability worsening.
    Results: CombiRx included 1,008 participants. A comparison of confirmed and sustained worsening events showed that, throughout the trial, there were substantially fewer sustained than confirmed events, with a positive predictive value of confirmed for sustained worsening at 24 months of 0.73 for the EDSS, 0.73 for the T25FW, and 0.8 for the NHPT. More concerning were the findings that worsening on the EDSS occurred as frequently as similarly defined improvement throughout the 3 years of follow-up and that improvement rates increased in parallel with worsening rates. The T25FW showed low improvement rates of <10% throughout the trial. We also found that Kaplan-Meier survival analysis, the standard presentation and analysis method in modern RRMS trials, yields exaggerated estimates of disability worsening. With the Kaplan-Meier method, the proportion of patients with worsening events steadily increases until it reaches several-fold the number of events seen with more conservative analysis methods. For 3-month confirmed disability worsening up to 36 months, the Kaplan-Meier method yields 2.6-fold higher estimates for the EDSS, 2.9-fold higher estimates for the T25FW, and 5.1-fold higher estimates for the NHPT compared to a more conservative presentation of the same data.
    Discussion: Our analyses raise concerns about using the EDSS as the standard disability outcome in RRMS trials and suggest that the T25FW may be a more useful measure. These findings are relevant for the design and critical appraisal of RCTs.
    Mesh-Begriff(e) Adult ; Disability Evaluation ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Glatiramer Acetate/administration & dosage ; Humans ; Interferon-beta/administration & dosage ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Treatment Outcome
    Chemische Substanzen Glatiramer Acetate (5M691HL4BO) ; Interferon-beta (77238-31-4)
    Sprache Englisch
    Erscheinungsdatum 2021-08-25
    Erscheinungsland United States
    Dokumenttyp Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 207147-2
    ISSN 1526-632X ; 0028-3878
    ISSN (online) 1526-632X
    ISSN 0028-3878
    DOI 10.1212/WNL.0000000000012690
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Response to letter 'Lymphocyte counts and the risk of COVID-19 in people with MS'.

    Loonstra, Floor C / van Kempen, Zoé LE / Strijbis, Eva M / Killestein, Joep / Hoitsma, Elske / Mostert, Jop P

    Multiple sclerosis (Houndmills, Basingstoke, England)

    2020  Band 27, Heft 10, Seite(n) 1626–1627

    Mesh-Begriff(e) COVID-19 ; Humans ; Lymphocyte Count ; SARS-CoV-2
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2020-10-16
    Erscheinungsland England
    Dokumenttyp Journal Article ; Comment
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458520965468
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel: COVID-19 in multiple sclerosis: The Dutch experience

    Loonstra, Floor C / Hoitsma, Elske / van Kempen, Zoé LE / Killestein, Joep / Mostert, Jop P

    Mult Scler

    Abstract: Here, we provide an extensive overview of all reported COVID-19 cases in multiple sclerosis (MS) patients in the Netherlands between 27 February and 9 June 2020, gathered by the Dutch MS Taskforce of the Netherlands Society of Neurology. A total of 86 MS ...

    Abstract Here, we provide an extensive overview of all reported COVID-19 cases in multiple sclerosis (MS) patients in the Netherlands between 27 February and 9 June 2020, gathered by the Dutch MS Taskforce of the Netherlands Society of Neurology. A total of 86 MS patients were reported, 43 of whom tested positive for COVID-19. Of 43 patients who tested positive, 22 patients were hospitalized. Three intensive care unit (ICU) admissions and four deaths were reported. Our findings show no apparent difference in disease-modifying treatment (DMT) use and COVID-19 disease course in Dutch MS patients. In addition, a clear link between low lymphocyte count and severe disease was not observed.
    Schlagwörter covid19
    Verlag WHO
    Dokumenttyp Artikel
    Anmerkung WHO #Covidence: #646629
    Datenquelle COVID19

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  7. Artikel ; Online: COVID-19 in multiple sclerosis

    Loonstra, Floor C / Hoitsma, Elske / van Kempen, Zoé LE / Killestein, Joep / Mostert, Jop P

    Multiple Sclerosis Journal

    The Dutch experience

    2020  Band 26, Heft 10, Seite(n) 1256–1260

    Abstract: Here, we provide an extensive overview of all reported COVID-19 cases in multiple sclerosis (MS) patients in the Netherlands between 27 February and 9 June 2020, gathered by the Dutch MS Taskforce of the Netherlands Society of Neurology. A total of 86 MS ...

    Abstract Here, we provide an extensive overview of all reported COVID-19 cases in multiple sclerosis (MS) patients in the Netherlands between 27 February and 9 June 2020, gathered by the Dutch MS Taskforce of the Netherlands Society of Neurology. A total of 86 MS patients were reported, 43 of whom tested positive for COVID-19. Of 43 patients who tested positive, 22 patients were hospitalized. Three intensive care unit (ICU) admissions and four deaths were reported. Our findings show no apparent difference in disease-modifying treatment (DMT) use and COVID-19 disease course in Dutch MS patients. In addition, a clear link between low lymphocyte count and severe disease was not observed.
    Schlagwörter Neurology ; Clinical Neurology ; covid19
    Sprache Englisch
    Verlag SAGE Publications
    Erscheinungsland us
    Dokumenttyp Artikel ; Online
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458520942198
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  8. Artikel: Response to letter 'Lymphocyte counts and the risk of COVID-19 in people with MS'

    Loonstra, Floor C / van Kempen, Zoé LE / Strijbis, Eva M / Killestein, Joep / Hoitsma, Elske / Mostert, Jop P

    Mult Scler

    Schlagwörter covid19
    Verlag WHO
    Dokumenttyp Artikel
    Anmerkung WHO #Covidence: #873850
    Datenquelle COVID19

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  9. Artikel ; Online: Response to letter ‘Lymphocyte counts and the risk of COVID-19 in people with MS’

    Loonstra, Floor C / van Kempen, Zoé LE / Strijbis, Eva M / Killestein, Joep / Hoitsma, Elske / Mostert, Jop P

    Multiple Sclerosis Journal

    2020  , Seite(n) 135245852096546

    Schlagwörter Neurology ; Clinical Neurology ; covid19
    Sprache Englisch
    Verlag SAGE Publications
    Erscheinungsland us
    Dokumenttyp Artikel ; Online
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458520965468
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  10. Artikel ; Online: Prospective trial of natalizumab personalised extended interval dosing by therapeutic drug monitoring in relapsing-remitting multiple sclerosis (NEXT-MS).

    Toorop, Alyssa A / van Lierop, Zoë Ygj / Gelissen, Liza My / Hoitsma, Elske / Zeinstra, Esther Mpe / van Rooij, Luuk C / van Munster, Caspar Ep / Vennegoor, Anke / Mostert, Jop P / Wokke, Beatrijs Ha / Kalkers, Nynke F / Hoogervorst, Erwin Lj / van Eijk, Jeroen Jj / Roosendaal, Christiaan M / Kragt, Jolijn J / Eurelings, Marijke / van Genugten, Jessie / Nielsen, Jessica / Sinnige, Lgf /
    Kloosterziel, Mark E / Arnoldus, Edo Pj / van Dijk, Gert W / Bouvy, Willem H / Wessels, Mark Hj / Boonkamp, Lynn / Strijbis, Eva Mm / van Oosten, Bob W / De Jong, Brigit A / Lissenberg-Witte, Birgit I / Barkhof, Frederik / Moraal, Bastiaan / Teunissen, Charlotte E / Rispens, Theo / Uitdehaag, Bernard Mj / Killestein, Joep / van Kempen, Zoé LE

    Journal of neurology, neurosurgery, and psychiatry

    2024  Band 95, Heft 5, Seite(n) 392–400

    Abstract: Background: Extended interval dosing (EID) of natalizumab is a promising strategy to optimise treatment in multiple sclerosis (MS). Personalised EID by therapeutic drug monitoring can enable further extension of treatment intervals.: Methods: The ... ...

    Abstract Background: Extended interval dosing (EID) of natalizumab is a promising strategy to optimise treatment in multiple sclerosis (MS). Personalised EID by therapeutic drug monitoring can enable further extension of treatment intervals.
    Methods: The NEXT-MS trial is an investigator-initiated prospective phase IV non-randomised study. Adults with a diagnosis of relapsing-remitting MS who received ≥6 natalizumab infusions were included in three groups: personalised EID with a target drug trough concentration of 10 µg/mL (EID10), an exploratory group of personalised EID with a target of 5 µg/mL (EID5) and standard interval dosing (SID) of 4 weeks. The primary outcome is radiological disease activity (new/newly enlarged T2 lesions) comparing the EID10 group to a historical cohort of SID (HSID).
    Results: Results of the first phase of the NEXT-MS trial are reported here (n=376) as the study will continue with an amended protocol. In the EID10 group (n=251), incidence rate of radiological activity was 10.0 per 1000 person-years, which was non-inferior to the HSID cohort (24.7 per 1000 person-years (n=87), incidence rate difference 14.7, 90% CI -4.5 to 34.0). Incidence rate of radiological activity was 10.0 per 1000 person-years in the EID5 group (n=65), and 47.0 per 1000 person-years in the SID group (n=60). Serum neurofilament light levels did not increase over time within the EID groups. There were no cases of progressive multifocal leukoencephalopathy.
    Conclusions: MS disease activity is adequately controlled with personalised natalizumab EID. Interval extension to a drug trough concentration of 5 µg/mL is likely a safe target to extend natalizumab treatment intervals >6 weeks.
    Trial registration number: NCT04225312.
    Mesh-Begriff(e) Adult ; Humans ; Drug Monitoring/adverse effects ; Immunologic Factors/therapeutic use ; Leukoencephalopathy, Progressive Multifocal/etiology ; Multiple Sclerosis/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/complications ; Natalizumab/therapeutic use ; Prospective Studies
    Chemische Substanzen Immunologic Factors ; Natalizumab
    Sprache Englisch
    Erscheinungsdatum 2024-04-12
    Erscheinungsland England
    Dokumenttyp Clinical Trial, Phase IV ; Journal Article
    ZDB-ID 3087-9
    ISSN 1468-330X ; 0022-3050
    ISSN (online) 1468-330X
    ISSN 0022-3050
    DOI 10.1136/jnnp-2023-332119
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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