MS Center Amsterdam, Amsterdam UMC, location VUmc
Neurology

Author Of 2 Presentations

Clinical Outcome Measures Poster Presentation

P0170 - The GNDS is suitable for changes in walking performance in progressive multiple sclerosis   (ID 1696)

Presentation Number
P0170
Presentation Topic
Clinical Outcome Measures

Abstract

Background

The Guy’s Neurological Disability scale (GNDS) and the Multiple Sclerosis Impact Scale (MSIS-29) are patient reported outcome measures (PROMs) which can serve as a proxy for measuring disability and impact in patients with diagnosed multiple sclerosis (pwMS). In times of increased interest for telemedicine such measures are important.

Objectives

The aim of this study was to investigate correlations between two multi-domain PROMs and often used clinical outcome measures.

Methods

248 MS patients were assessed using the GNDS, the physical part of the MSIS-29 (MSIS-phys), the Expanded Disability Status Scale (EDSS), the 9-hole peg test (9-HPT) and the Timed 25-foot walk test (T25WT) at baseline (BSL) and follow-up (FU) with a mean of 6.4 years. Cross-sectional and longitudinal correlations were studied between the overall scores and specific subcategories of the PROMs and clinical outcome measures. Additionally, the relationship between clinically significant changes in the PROMs and clinical outcomes were studied. We defined a clinically significant change of three or more points on the GDNS, eight or more points on the MSIS-phys and one point or more on an EDSS score <5.5 and one-half point or more on an EDSS score ≥5.

Results

Strong cross-sectional correlations were found between the “legs” domain of the GNDS and the pyramidal functional system (p-FS) of the EDSS (Rbsl(247)=.55, p<0.001; RFU(238)=.77, p<0.001) and the T25WT (RBSL(247)=.56, p=0.000; RFU(233)=.77, p<0.001) especially in progressive patients (PPMSbsl R(34)=.76, p<0.001; PPMSFU R(26)=.86, p<0.001, SPMSBSL R(21)=.61, P=0.003; SPMSFUR(34)=.82, p<0.001). The MSIS-phys also showed strong correlations compared to the p-FS of the EDSS RBSL(162)=.59, p<0.001; RFU(236)=.70, p<0.001) and T25WT RBSL(162)=.61, p<0.001; RFU(231)=.61, p<0.001). Only good correlations were found between the MSIS-phys and T25WT in RRMS patients (RBSL(114)=.45, p<0.001; RFU(172)=.54, p<0.001).

Longitudinal correlations for the global GNDS/MSIS-phys and EDSS/MSFC were relatively poor except for changes on the leg domain of the GNDS in relation to changes on the T25WT (R(231)=.58, p<0.001), especially in PPMS patients (R(25)=.68, p<0.001). In the majority of cases a clinically significant deterioration on the EDSS also resulted in a clinically significant worsening of the GDNS and MSIS-phys.

Conclusions

The GNDS and MSIS-phys correlate well with clinical outcome measures for physical disability. The GNDS in particular, for the lower limb function in progressive patients. PROMs are easy to apply, less-time consuming and are a more cost-effective way of capturing patients’ disability.

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Disease Modifying Therapies – Risk Management Poster Presentation

P0398 - Switching from natalizumab to ocrelizumab in patients with relapsing-remitting multiple sclerosis. (ID 1725)

Speakers
Presentation Number
P0398
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab (OCR) is an alternative therapy for relapsing-remitting multiple sclerosis (RRMS) patients with an increased risk of natalizumab (NTZ) associated progressive multifocal leukoencephalopathy (PML). We developed a switch protocol for PML surveillance and prevention of rebound disease activity.

Objectives

To evaluate clinical, radiological and biochemical markers in patients switching from NTZ to OCR using the locally developed switch protocol of the MS Center Amsterdam.

Methods

All patients with previous NTZ and current OCR treatment were selected from an ongoing observational cohort study with regular collection of blood samples in the Amsterdam University Medical Center (UMC) MS Biobank. Reasons for therapy switch were discriminated between patients with (indirect switchers) and without (direct switchers) use of other disease modifying treatment (DMT) during interval. Clinical, biochemical and radiological endpoints were prospectively collected from first NTZ to last OCR infusion. Serum neurofilament light (sNfL) was analyzed in direct switchers, using baseline and last follow-up samples during NTZ treatment and samples taken before every OCR infusion.

Results

Forty-one patients with current OCR and previous NTZ treatment were included with a median follow-up of 7.7 years. Twenty-eight patients switched directly, of which 21 due to PML risk. Three direct switchers suffered from a relapse, of which 1 patient showed evidence of disease activity on brain Magnetic Resonance Imaging (MRI). Two other male patients were diagnosed with carry-over PML with favorable outcomes. Before OCR became available, 13 patients switched from NTZ to other DMT due to PML risk but eventually escalated to OCR because of disease activity, progression or adverse events. Among these indirect switchers, 4 patients showed evidence of clinical or radiological disease activity. Excluding carry-over PML, OCR treatment maintained or established complete disease activity suppression in 84% of patients. Clinical measures of disability showed no significant changes. Mean sNfL significantly decreased during NTZ treatment and remained stable during OCR treatment.

Conclusions

A stringent protocol can contribute to an effective switch from NTZ to OCR in RRMS. In this observational cohort study of direct and indirect switchers, disease activity suppression was maintained or established in 84% with concurrent stability of clinical measures and sNfL.

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