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Article ; 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 Volume 27, Issue 12, Page(s) 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 term(s)	Disability Evaluation ; Disabled Persons ; Humans ; Multiple Sclerosis, Chronic Progressive/diagnosis ; Outcome Assessment, Health Care ; Walking
Language	English
Publishing date	2021-01-19
Publishing country	England
Document type	Journal Article
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458520987539
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Article ; Online: Response to Grech et al.: FLOUX-PMS study sample considerations.

Mostert, Jop P / De Keyser, Jacques

Multiple sclerosis (Houndmills, Basingstoke, England)

2019 Volume 25, Issue 13, Page(s) 1820–1821

MeSH term(s)	Demyelinating Diseases ; Fluoxetine ; Humans ; Multiple Sclerosis
Chemical Substances	Fluoxetine (01K63SUP8D)
Language	English
Publishing date	2019-09-20
Publishing country	England
Document type	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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Article ; 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 Volume 26, Issue 10, Page(s) 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 term(s)	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
Chemical Substances	Immunologic Factors
Keywords	covid19
Language	English
Publishing date	2020-07-14
Publishing country	England
Document type	Journal Article
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458520942198
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Article ; 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 Volume 97, Issue 16, Page(s) 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 term(s)	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
Chemical Substances	Glatiramer Acetate (5M691HL4BO) ; Interferon-beta (77238-31-4)
Language	English
Publishing date	2021-08-25
Publishing country	United States
Document type	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
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Article ; 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 Volume 27, Issue 10, Page(s) 1626–1627

MeSH term(s)	COVID-19 ; Humans ; Lymphocyte Count ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-10-16
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458520965468
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Article: 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 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.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #646629
Database	COVID19

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Article ; 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 Volume 26, Issue 10, Page(s) 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 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.
Keywords	Neurology ; Clinical Neurology ; covid19
Language	English
Publisher	SAGE Publications
Publishing country	us
Document type	Article ; Online
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458520942198
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: 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

Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #873850
Database	COVID19

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Article ; 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 , Page(s) 135245852096546

Keywords	Neurology ; Clinical Neurology ; covid19
Language	English
Publisher	SAGE Publications
Publishing country	us
Document type	Article ; Online
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458520965468
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; 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 Volume 95, Issue 5, Page(s) 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 term(s)	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
Chemical Substances	Immunologic Factors ; Natalizumab
Language	English
Publishing date	2024-04-12
Publishing country	England
Document type	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
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