Evaluation of the symbol digit modalities test (SDMT) and MS neuropsychological screening questionnaire (MSNQ) in natalizumab-treated MS patients over 48 weeks

2010 ◽  
Vol 16 (11) ◽  
pp. 1385-1392 ◽  
Author(s):  
SA Morrow ◽  
PW O'Connor ◽  
CH Polman ◽  
AD Goodman ◽  
L Kappos ◽  
...  
Keyword(s):  
Geographic Region ◽  
Cognitive Tests ◽  
Expanded Disability Status Scale ◽  
Open Label ◽  
Neuropsychological Screening ◽  
Disease Modifying Therapy ◽  
Monitoring Tools ◽  
Small Effect Size ◽  
Disability Status ◽  
Monthly Changes

Background and Objectives: Brief cognitive tests to monitor cognitive impairment in patients with multiple sclerosis (MS) are needed. Methods: Performance on monthly administrations of the Symbol Digit Modalities Test (SDMT) and the MS Neuropsychological Questionnaire (MSNQ) was assessed in 660 patients with MS in 21 countries (109 sites) for 48 weeks in an open-label, safety-extension study of natalizumab. Results: At baseline, the cohort’s mean age was 40.1 years, 67.6% were female and the median Expanded Disability Status Scale score was 2.5. Test—retest correlations were high for both SDMT (range 0.89 for weeks 0—4 to 0.96 for weeks 44—48) and MSNQ (0.82 for weeks 0—4 to 0.93 for weeks 44—48). There were no statistically significant effects of geographic region. While SDMT scores improved by 15 points over 48 weeks ( p < 0.0001), incremental monthly changes were small (effect size d < 0.3). Similar results were obtained on the MSNQ except that scores moved downward, suggesting fewer cognitive complaints over 48 weeks ( p < 0.0001), but again the incremental monthly changes were small ( d <-0.2). Conclusions: These results replicate earlier work in a smaller cohort treated with conventional disease-modifying therapy, and support the reliability of the SDMT and MSNQ as potential screening for monitoring tools for cognition over time.

THUR 193 Alemtuzumab improves disability across functional systems

2018 ◽  
Vol 89 (10) ◽  
pp. A28.1-A28
Author(s):  
Sharrack Basil ◽  
Hunter Samuel ◽  
Aburashed Rany ◽  
Alroughani Raed ◽  
Dive Dominique ◽  
...  
Keyword(s):  
Expanded Disability Status Scale ◽  
Functional Systems ◽  
Link Type ◽  
Disease Modifying Therapy ◽  
Disability Status ◽  
Bayer Healthcare ◽  
Core Study ◽  
Study Support ◽  
Disease Modifying ◽  
Edss Score

The effect of alemtuzumab on functional systems (FS) scores of the Expanded Disability Status Scale (EDSS) was assessed in CARE-MS II patients over 6 years (y) (CARE-MS II, NCT00548405; extension, NCT00930553). Patients received alemtuzumab (12 mg/day; 2 courses: baseline, 5 days; 12 months later, 3 days), and as-needed alemtuzumab retreatment for relapse/MRI activity in the extension or another disease-modifying therapy per investigator discretion. Assessments: Proportion of patients achieving stable/improved EDSS score (versus core study baseline), FS scores, and 6 month confirmed disability improvement (CDI). In patients who achieved CDI over 6 y (n=126), assessments at 6 months post-CDI onset: EDSS score (<4; ≥4), number of improved FS per patient, and percentage with stable/improved FS scores. At Y6, 77% of patients showed stable/improved EDSS scores; 75%–85% showed stability/improvement in each FS. Through Y6, 43% achieved 6 month CDI. At 6 months post-CDI onset, 96% of CDI patients had an EDSS score <4, and 70% achieved improvements in >1 FS. Improvements were observed in each FS, most frequently Sensory (48%), Pyramidal (44%), and Cerebellar (44%) systems; 21%–25% showed improvements in the Brainstem, Cerebral, Visual, and Bowel/Bladder FS. These findings indicate a broad treatment effect of alemtuzumab on multiple aspects of disability improvements. STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.

scholarly journals The Value of Self-Reported Cognitive Performance in low, medium and high EDSS

2021 ◽  
Author(s):  
Delphine Van Laethem ◽  
Alexander De Cock ◽  
Jeroen Van Schependom ◽  
Ralph HB Benedict ◽  
Guy Nagels ◽  
...  
Keyword(s):  
Cognitive Performance ◽  
Physical Disability ◽  
Screening Tool ◽  
Cognitive Tests ◽  
Expanded Disability Status Scale ◽  
Patient Report ◽  
Patient Reported ◽  
Disability Status ◽  
Degree Of Disability ◽  
Positive Correlations

AbstractBackgroundThe inconsistent association of patient-reported Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) scores with performance-based cognitive tests in MS could be related to the degree of disability, due to certain MSNQ-questions assuming some self-dependence and intact instrumental ADLs.ObjectivesTo test whether the relation between subjective and objective cognitive performance could be moderated by physical disability as measured by the Expanded Disability Status Scale (EDSS), we assessed the correlation between MSNQ and Symbol Digit Modalities Test (SDMT) scores in different EDSS groups.MethodsFrom 288 MS patients who completed the patient-report MSNQ and a two‐question screening tool for depression, we also collected SDMT and EDSS scores. We analysed correlations in the total group and three EDSS subgroups: Low 0.0 – 3.0, Medium 3.5 – 6.0 and High 6.5 – 9.5.ResultsWe found a significant and negative correlation between patient-reported MSNQ scores and SDMT scores in the low EDSS (r = -.225, p = .044), but not in the medium and high EDSS groups, and significant positive correlations between MSNQ and depression in all subgroups.ConclusionsOur data suggest that the patient-report MSNQ has potential as a measure of cognition in patients with low EDSS-scores but not in the medium and high EDSS ranges.

THUR 177 Efficacy of alemtuzumab retreatment after 2 initial courses

2018 ◽  
Vol 89 (10) ◽  
pp. A23.2-A23
Author(s):  
Sharrack Basil ◽  
Singer Barry ◽  
Boster Aaron ◽  
Bass Ann ◽  
Berkovich Regina ◽  
...  
Keyword(s):  
Rate Ratio ◽  
Expanded Disability Status Scale ◽  
Link Type ◽  
Disease Modifying Therapy ◽  
Disability Status ◽  
Bayer Healthcare ◽  
Core Study ◽  
Study Support ◽  
Disease Modifying ◽  
Edss Score

Efficacy of alemtuzumab retreatment (course [C] 3) after the initial 2 courses were evaluated (CARE-MS II, NCT00548405; extension, NCT00930553). Patients received alemtuzumab retreatment (12 mg/day, 3 consecutive days;≥12 months apart) as needed for relapse and/or MRI activity or another disease-modifying therapy (DMT) per investigator’s discretion. Assessments 12 months before C3 and up to 3 years after C3: annualised relapse rate (ARR); improved/stable Expanded Disability Status Scale (EDSS) score (versus core study baseline); 6 month confirmed disability improvement (CDI). Patients receiving another DMT were excluded. Analyses included patients who received C3 or more, with data censored at the time of C4 if a fourth course was received. Through Year 6, 88% of patients entering the extension remained on study, with 45% receiving ≥1 retreatment. ARR decreased from 0.85 (12 months before C3) to 0.20 (12 months after C3; rate ratio [95% CI], 0.24 [0.17–0.34]; p<0.0001), and remained low (0.27) 3 years after C3. 68% of patients maintained stable/improved EDSS 12 months after C3. The percentage with CDI increased from 4% (12 months before C3) to 14% (12 months after C3; p=0.0126). These findings demonstrate the efficacy of alemtuzumab C3 in patients with disease activity after the initial 2 courses.Study support: Sanofi and Bayer HealthCare Pharmaceuticals.

scholarly journals Comparison of first-line and second-line use of fingolimod in relapsing MS: The open-label EARLIMS study

2020 ◽  
Vol 6 (3) ◽  
pp. 205521732095735
Author(s):  
Oscar Fernández ◽  
Guillermo Izquierdo ◽  
Eduardo Aguera ◽  
Cristina Ramo ◽  
Miguel Hernandez ◽  
...  
Keyword(s):  
Second Line ◽  
Open Label ◽  
Disease Modifying Therapy ◽  
Parallel Group ◽  
Patient Reported ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Treatment Naïve ◽  
Previously Treated ◽  
Clinical Mri

Background Treatment of MS often begins with low-efficacy injectable disease-modifying therapy (iDMT). Objectives To compare the effect of fingolimod 0.5 mg/day on clinical, MRI, patient-reported, and safety outcomes, in treatment-naïve and previously treated (≥1 iDMT) patients with early MS. Methods EARLIMS was a multicentre, open-label, non-randomized, parallel-group phase 3 b/4 study in Australia and Spain. Patients with relapsing–remitting MS, Expanded Disability Status Scale (EDSS) score <4.0, and ≥1–5 years since diagnosis, received daily fingolimod for 48 weeks. The primary endpoint was annualized relapse rate (ARR). Results Of 347 patients enrolled at 51 sites (treatment-naïve, 200 [57.6%]; previously treated, 147 [42.4%]), 320 completed the study (treatment-naïve, 184 [92.0%]; previously treated, 136 [92.5%]), but the study remained underpowered (planned enrolment, n = 432). Fingolimod reduced ARR to similar levels in both treatment-naïve (mean ARR [95% confidence interval], 0.21 [0.14, 0.29]) and previously treated groups (0.30 [0.20, 0.41]; p = 0.1668). There were no new safety signals. Conclusions Fingolimod appeared equally effective as first- or second-line therapy in relapsing MS. There was a trend for better outcomes with fingolimod in treatment-naïve patients than in those previously treated with >1 iDMT.

scholarly journals P.027 Efficacy of a fourth alemtuzumab course in RRMS patients from CARE-MS II who experienced disease activity after three prior courses

2018 ◽  
Vol 45 (s2) ◽  
pp. S23-S23
Author(s):  
A Traboulsee ◽  
R Alroughani ◽  
A Boster ◽  
AD Bass ◽  
R Berkovich ◽  
...  
Keyword(s):  
Disease Activity ◽  
Inadequate Response ◽  
Expanded Disability Status Scale ◽  
Inclusion Criteria ◽  
Prior Therapy ◽  
Disease Modifying Therapy ◽  
Improved Outcomes ◽  
Disability Status ◽  
Disease Modifying ◽  
Edss Score

Background: In RRMS patients with inadequate response to prior therapy, 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved outcomes versus SC IFNB-1a over 2 years (CARE-MS II [NCT00548405]). Efficacy remained durable in a 4-year extension (NCT00930553); patients could receive as-needed alemtuzumab retreatment (≥12 months apart) for disease activity, or another disease-modifying therapy (DMT). Through Year 6, 88% remained on study; 50% received neither alemtuzumab retreatment nor another DMT; 16% received ≥4 courses; 3% received ≥5 courses. We evaluated Course 4 (C4) efficacy in patients receiving ≥4 courses. Methods: Annualized relapse rate (ARR); improved/stable Expanded Disability Status Scale (EDSS) score (versus baseline); 6-month confirmed disability improvement (CDI). 11% of patients met inclusion criteria: ≥4 courses within 60 months of baseline; no DMT. Those receiving C5 were censored at that time. Results: ARR decreased after C4 (12 months pre-C4 [-12M]: 0.75; 12 months post-C4 [+12M]: 0.19; P<0.0001), remaining low (0.23) at Year 3 post-C4. More patients had stable/improved EDSS scores +12M (67.5%) versus at C4 administration (53.5%). Percentage with CDI increased post-C4 (-12M: 10.0%; +12M: 26.7%). Conclusions: C4 reduced relapses and stabilized/improved disability in patients with disease activity after initial treatment (C1, C2) plus one additional course (C3).

scholarly journals Natalizumab-PML survivors with subsequent MS treatment

2017 ◽  
Vol 4 (3) ◽  
pp. e346 ◽  
Author(s):  
Elisabeth Maillart ◽  
Jean-Sebastien Vidal ◽  
David Brassat ◽  
Bruno Stankoff ◽  
Agnès Fromont ◽  
...  
Keyword(s):  
Therapeutic Strategy ◽  
Dimethyl Fumarate ◽  
Expanded Disability Status Scale ◽  
Disability Progression ◽  
Disease Modifying Therapy ◽  
Multicenter Cohort ◽  
Disability Status ◽  
Disease Modifying ◽  
Clinical Worsening

Objective:To describe the clinico-radiologic outcome of MS patients with natalizumab-related progressive multifocal leukoencephalopathy (Nz-PML) surviving and receiving disease-modifying therapy (DMT).Methods:We describe clinical and radiologic evolution of Nz-PML survivors in an observational retrospective multicenter cohort to clarify the effect of different subsequent MS DMT strategies. Twenty-three patients from 11 centers were analyzed. Outcomes were (1) clinical efficacy of post-PML MS DMT, (2) radiologic efficacy of post-PML MS DMT, (3) radiologic evolution of PML lesion, and (4) disability progression.Results:There was no clinical worsening of PML symptoms with a stability of Expanded Disability Status Scale at the last follow-up. No relapse was reported with fingolimod and dimethyl fumarate. No radiologic worsening of Nz-PML lesion was observed at the end of the follow-up.Conclusion:In this large cohort of patients with Nz-PML, MS therapies given after Nz discontinuation were not associated with PML worsening. A larger cohort with longer follow-up will be necessary to confirm this therapeutic strategy.

The EDSS integration with the Brief International Cognitive Assessment for Multiple Sclerosis and orientation tests

2016 ◽  
Vol 23 (9) ◽  
pp. 1289-1296 ◽  
Author(s):  
Francesco Saccà ◽  
Teresa Costabile ◽  
Antonio Carotenuto ◽  
Roberta Lanzillo ◽  
Marcello Moccia ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Assessment ◽  
Neuropsychological Tests ◽  
Functional System ◽  
Male Gender ◽  
Cognitive Tests ◽  
Expanded Disability Status Scale ◽  
Everyday Clinical Practice ◽  
Disability Status ◽  
Lower Education

Objective: Despite cognitive tests have been validated in multiple sclerosis (MS), a neuropsychological evaluation is not implemented in the Expanded Disability Status Scale (EDSS) scoring. Methods: We used the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and orientation tests (OTs) to measure the cerebral functional system (CFS) score and to evaluate its impact on the EDSS. We compared EDSS calculated as usual (Native-EDSS) and after the use of the BICAMS and OT (NPS-EDSS). Results: We tested 604 MS patients with BICAMS, OTs, and EDSS. In all, 384 patients (63.6%) had at least one altered test at the BICAMS. Older age, lower education, higher Native-EDSS, and male gender were independently associated with at least one impaired BICAMS test. Native-EDSS was different from NPS-EDSS (−0.112; p < 0.001) in 99 patients (16%). When considering patients with a Native-EDSS ⩽ 4.0, the proportion of miscalculated EDSS was 25%. Conclusion: The use of brief neuropsychological tests leads to a more accurate CFS assessment in two-thirds of MS patients, and a more accurate EDSS calculation in 25% of patients with a score ⩽4.0. This may help clinicians to better recognize cognitive impairment in everyday clinical practice, especially in the case of isolated cognitive worsening.

Validierung von Selbstbewertungsskalen bei Multipler Sklerose: Brauchen wir noch die Expanded-Disability-Status-Scale (EDSS)?

2004 ◽  
Vol 31 (S 1) ◽  
Author(s):  
K Ziegler ◽  
C Borchers ◽  
K Schulz ◽  
S Gold ◽  
I Wölfel ◽  
...  
Keyword(s):  
Expanded Disability Status Scale ◽  
Disability Status

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

2018 ◽  
Vol 12 (01) ◽  
pp. 144-148 ◽  
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.

scholarly journals Determinants of therapeutic lag in multiple sclerosis

2021 ◽  
pp. 135245852098130
Author(s):  
Izanne Roos ◽  
Emmanuelle Leray ◽  
Federico Frascoli ◽  
Romain Casey ◽  
J William L Brown ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Expanded Disability Status Scale ◽  
Disability Progression ◽  
Delayed Onset ◽  
Disease Characteristics ◽  
Disability Status ◽  
Male Sex ◽  
Pre Treatment ◽  
Patient Subgroups

Background: A delayed onset of treatment effect, termed therapeutic lag, may influence the assessment of treatment response in some patient subgroups. Objectives: The objective of this study is to explore the associations of patient and disease characteristics with therapeutic lag on relapses and disability accumulation. Methods: Data from MSBase, a multinational multiple sclerosis (MS) registry, and OFSEP, the French MS registry, were used. Patients diagnosed with MS, minimum 1 year of exposure to MS treatment and 3 years of pre-treatment follow-up, were included in the analysis. Studied outcomes were incidence of relapses and disability accumulation. Therapeutic lag was calculated using an objective, validated method in subgroups stratified by patient and disease characteristics. Therapeutic lag under specific circumstances was then estimated in subgroups defined by combinations of clinical and demographic determinants. Results: High baseline disability scores, annualised relapse rate (ARR) ⩾ 1 and male sex were associated with longer therapeutic lag on disability progression in sufficiently populated groups: females with expanded disability status scale (EDSS) < 6 and ARR < 1 had mean lag of 26.6 weeks (95% CI = 18.2–34.9), males with EDSS < 6 and ARR < 1 31.0 weeks (95% CI = 25.3–36.8), females with EDSS < 6 and ARR ⩾ 1 44.8 weeks (95% CI = 24.5–65.1), and females with EDSS ⩾ 6 and ARR < 1 54.3 weeks (95% CI = 47.2–61.5). Conclusions: Pre-treatment EDSS and ARR are the most important determinants of therapeutic lag.

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