Greater sensitivity to multiple sclerosis disability worsening and progression events using a roving versus a fixed reference value in a prospective cohort study

Background: Confirmed Expanded Disability Status Scale (EDSS) progression occurring after a fixed-study entry baseline is a common measure of disability increase in relapsing-remitting multiple sclerosis (RRMS) studies but may not detect all disability progression events, especially those unrelated to overt relapses. Objective: To evaluate possible measures of disability progression unrelated to relapse using EDSS data over ≈5.5 years from the Tysabri® Observational Program (TOP). Methods: TOP is an ongoing, prospective, open-label study in RRMS patients receiving intravenous 300 mg natalizumab every 4 weeks. Measures of increasing disability were assessed using as a reference either study baseline score or a “roving” system that resets the reference score after ⩾24- or ⩾48-week confirmation of a new score. Results: This analysis included 5562 patients. Approximately 70% more EDSS progression events unrelated to relapse and 50% more EDSS worsening events overall were detected with a roving reference score (cumulative probability: 17.6% and 29.7%, respectively) than with a fixed reference baseline score (cumulative probability: 10.1% and 20.3%, respectively). Conclusion: In this long-term observational RRMS dataset, a roving EDSS reference value was more efficient than a study baseline EDSS reference in detecting progression/worsening events unrelated to relapses and thus the transition to secondary progressive disease.

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Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate in relapsing—remitting multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458507085029 ◽

2008 ◽

Vol 14 (4) ◽

pp. 494-499 ◽

Cited By ~ 31

Author(s):

Aaron Miller ◽

Vincent Spada ◽

Dorothy Beerkircher ◽

Rivka Riven Kreitman

Keyword(s):

Multiple Sclerosis ◽

Adverse Events ◽

Glatiramer Acetate ◽

Open Label ◽

Disability Status ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis ◽

Pretreatment Score

To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 46 patients with relapsing—remitting multiple sclerosis (RRMS) were treated for up to 22 years in an ongoing, open-label study. Kurtzke expanded disability status scale (EDSS) was measured every six months, relapses were reported at occurrence and patients self-reported adverse events (AEs). At GA initiation, disease durations ranged from 0—20 years (median 6.0 years) and at data cut-off (October 2004), GA therapy duration ranged from 1—22 years (median 12.0 years). Mean EDSS score increased 0.9 ± 1.9 from the pretreatment score (3.0 ± 1.8; P = 0.076). Only 10/28 (36%) patients with baseline EDSS <4.0 had a last observed value ≥ 4.0 and 8/34 (24%) with entry EDSS < 6.0 reached EDSS ≥ 6.0. A majority (57%) maintained improved or unchanged EDSS scores. Annualized relapse rate decreased to 0.1 ± 0.2 from 2.9 ± 1.4 prestudy ( P < 0.0001). Of the 18 remaining patients in October 2004 (average disease duration 23 years), 17% with baseline EDSS scores < 4.0 reached EDSS ≥ 4.0 and 28% with baseline scores < 6.0 reached EDSS ≥ 6.0. Adverse events were similar to those reported in short-term clinical trials. This study shows a low rate of relapses and EDSS progression in RRMS patients on GA for up to 22 years. Multiple Sclerosis 2008; 14: 494—499. http://msj.sagepub.com

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gMS-Classifier1 Serum Assay Is Associated with Faster Relapsing-Remitting Multiple Sclerosis (RRMS) Disability Progression, Reaching Expanded Disability Status Scale (EDSS) >= 4.0 - A Retrospective Analysis (P02.092)

Neurology ◽

10.1212/wnl.78.1_meetingabstracts.p02.092 ◽

2012 ◽

Vol 78 (Meeting Abstracts 1) ◽

pp. P02.092-P02.092

Author(s):

J. Yarden ◽

H. Schmidt ◽

L. Spector ◽

M. Rimer ◽

S. Loud ◽

...

Keyword(s):

Multiple Sclerosis ◽

Retrospective Analysis ◽

Expanded Disability Status Scale ◽

Disability Progression ◽

Serum Assay ◽

Disability Status ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

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Multimodal evoked potentials measure and predict disability progression in early relapsing–remitting multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458507085758 ◽

2008 ◽

Vol 14 (4) ◽

pp. 553-556 ◽

Cited By ~ 46

Author(s):

P Jung ◽

A Beyerle ◽

U Ziemann

Keyword(s):

Multiple Sclerosis ◽

Early Stage ◽

Expanded Disability Status Scale ◽

Disability Progression ◽

Multiple Sclerosis Functional Composite ◽

Disability Status ◽

Relapsing Remitting ◽

Multimodal Evoked Potentials ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

In 37 patients with early relapsing–remitting multiple sclerosis (RRMS), a multimodal EP score (mEPS) and clinical scores (Expanded Disability Status Scale (EDSS) and multiple sclerosis functional composite (MSFC)) were obtained prospectively over 24 months. Changes in mEPS correlated with changes in EDSS (Spearman’s ρ = 0.69, p < 0.0001) and MSFC (ρ = –0.41, p < 0.02). Patients with relevant EDSS progression ( n = 7) showed stronger mEPS deterioration than clinically stable patients (10.8 ± 3.2 versus 1.3 ± 0.8, p < 0.005). Baseline mEPS was not significantly correlated with baseline EDSS but with EDSS after 24 months (ρ = 0.39, p < 0.02). The data suggest that serial mEPS measure and moderately predict clinically relevant disease activity in the therapeutically most relevant early stage of RRMS.

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EVOLVE-MS-1: a phase 3, open-label, long-term safety study of ALKS 8700 in relapsing-remitting multiple sclerosis

10.26226/morressier.59a3edabd462b8028d8952fe ◽

2017 ◽

Author(s):

Robert T. Naismith

Keyword(s):

Multiple Sclerosis ◽

Open Label ◽

Safety Study ◽

Phase 3 ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

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Predictors of long term disability progression in patients with relapsing remitting multiple sclerosis

10.26226/morressier.5b719e445aff74008ae4ce73 ◽

2018 ◽

Author(s):

Valentina Ignatova

Keyword(s):

Multiple Sclerosis ◽

Disability Progression ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

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Relationship between Expanded Disability Status Scale scores and the presence of temporomandibular disorders in patients with multiple sclerosis

European Journal of Dentistry ◽

10.4103/ejd.ejd_91_17 ◽

2018 ◽

Vol 12 (01) ◽

pp. 144-148 ◽

Cited By ~ 2

Author(s):

Lucas Senra Correa Carvalho ◽

Osvaldo José Moreira Nascimento ◽

Luciane Lacerda Franco Rocha Rodrigues ◽

Andre Palma Da Cunha Matta

Keyword(s):

Multiple Sclerosis ◽

Temporomandibular Disorders ◽

Control Group ◽

Expanded Disability Status Scale ◽

Exact Test ◽

Disability Status ◽

Relapsing Remitting ◽

Scale Scores ◽

Axis I ◽

Relapsing Remitting Multiple Sclerosis

ABSTRACTObjectives: The objectives of this study were to assess the prevalence of temporomandibular disorders (TMDs) in patients with relapsing-remitting multiple sclerosis (MS) and to investigate whether an association exists between the presence of TMD symptoms and the degree of MS-related disability. Materials and Methods: In all, 120 individuals were evaluated: 60 patients with a diagnosis of relapsing-remitting MS and 60 age- and sex-matched controls without neurological impairments. A questionnaire recommended by the European Academy of Craniomandibular Disorders for the assessment of TMD symptoms was administered. For those who answered affirmatively to at least one of the questions, the RDC/TMD Axis I instrument was used for a possible classification of TMD subtypes. The Expanded Disability Status Scale (EDSS) was the measure of the degree of MS-related disability. Statistical Analysis Used: Fisher’s exact test was used to analyze the data. ANOVA was used to detect significant differences between means and to assess whether the factors influenced any of the dependent variables by comparing means from the different groups. Results: The prevalence of TMD symptoms in patients with MS was 61.7% versus 18.3% in the control group (CG). A diagnosis of TMD was established for 36.7% in the MS group and 3.3% in the CG (P = 0.0001). There were statistically significant differences between degrees of MS-related disability and the prevalence of TMD (P = 0.0288). Conclusions: The prevalence of both TMD and TMD symptoms was significantly greater in the MS group. EDSS scores and TMD prevalence rates were inversely related.

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Assessment of Disability Progression Independent of Relapse and Brain MRI Activity in Patients with Multiple Sclerosis in Poland

Journal of Clinical Medicine ◽

10.3390/jcm10040868 ◽

2021 ◽

Vol 10 (4) ◽

pp. 868

Author(s):

Katarzyna Kapica-Topczewska ◽

François Collin ◽

Joanna Tarasiuk ◽

Agata Czarnowska ◽

Monika Chorąży ◽

...

Keyword(s):

Multiple Sclerosis ◽

Brain Activity ◽

Brain Mri ◽

Disability Progression ◽

Program Monitoring ◽

Therapeutic Program ◽

Relapsing Remitting ◽

Second Year ◽

Multiple Sclerosis Patients ◽

Relapsing Remitting Multiple Sclerosis

The aim of the study was to verify the association of clinical relapses and brain activity with disability progression in relapsing/remitting multiple sclerosis patients receiving disease-modifying treatments in Poland. Disability progression was defined as relapse-associated worsening (RAW), progression independent of relapse activity (PIRA), and progression independent of relapses and brain MRI Activity (PIRMA). Data from the Therapeutic Program Monitoring System were analyzed. Three panels of patients were identified: R0, no relapse during treatment, and R1 and R2 with the occurrence of relapse during the first and the second year of treatment, respectively. In the R0 panel, we detected 4.6% PIRA patients at 24 months (p < 0.001, 5.0% at 36 months, 5.6% at 48 months, 6.1% at 60 months). When restricting this panel to patients without brain MRI activity, we detected 3.0% PIRMA patients at 12 months, 4.5% at 24 months, and varying from 5.3% to 6.2% between 36 and 60 months of treatment, respectively. In the R1 panel, RAW was detected in 15.6% patients at 12 months and, in the absence of further relapses, 9.7% at 24 months and 6.8% at 36 months of treatment. The R2 group was associated with RAW significantly more frequently at 24 months compared to the R1 at 12 months (20.7%; p < 0.05), but without a statistical difference later on. In our work, we confirmed that disability progression was independent of relapses and brain MRI activity.

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