Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis DOI Creative Commons
Ih Chang, Ludwig Kappos, Gavin Giovannoni

и другие.

Multiple Sclerosis Journal, Год журнала: 2022, Номер 28(14), С. 2263 - 2273

Опубликована: Сен. 21, 2022

Background: Overall Disability Response Score (ODRS) is a composite endpoint including Expanded Status Scale, Timed 25-foot Walk, and 9-Hole Peg Test, designed to quantify both disability improvement worsening in multiple sclerosis (MS). Objective: To assess the sensitivity clinical meaningfulness of ODRS using natalizumab Phase 3 data sets (AFFIRM relapsing-remitting MS ASCEND secondary progressive MS). Methods: Differences over 96 weeks, at Week 96, slope change per year between placebo groups were analyzed. Correlation changes patient-reported outcomes was also Results: The difference (95% confidence interval (CI)) weeks 0.34 (0.21–0.46) AFFIRM ( p < 0.001), 0.18 (0.03–0.34) = 0.021). Significant differences treatment arms observed studies. There significant linear correlation from baseline physical mental components 36-item Short Form Survey (SF-36) Conclusion: This analysis supports as sensitive potentially clinically meaningful outcome measure MS.

Язык: Английский

Clinical outcome measures in multiple sclerosis: A review DOI
Hernán Inojosa, Dirk Schriefer, Tjalf Ziemssen

и другие.

Autoimmunity Reviews, Год журнала: 2020, Номер 19(5), С. 102512 - 102512

Опубликована: Март 12, 2020

Язык: Английский

Процитировано

139
Comparative efficacy and acceptability of disease-modifying therapies in patients with relapsing–remitting multiple sclerosis: a systematic review and network meta-analysis DOI
Huihui Li,

Fengli Hu,

Yanli Zhang

и другие.

Journal of Neurology, Год журнала: 2019, Номер 267(12), С. 3489 - 3498

Опубликована: Май 25, 2019

Язык: Английский

Процитировано

123
Identifying Progression in Multiple Sclerosis: New Perspectives DOI
Massimo Filippi, Paolo Preziosa, Dawn Langdon

и другие.

Annals of Neurology, Год журнала: 2020, Номер 88(3), С. 438 - 452

Опубликована: Июнь 7, 2020

The identification of progression in multiple sclerosis is typically retrospective. Given the profound burden progressive sclerosis, and recent development effective treatments for these patients, there a need to establish measures capable identifying early disease course. Starting from pathological findings, this review assesses state art potential able predict sclerosis. Future promising biomarkers that might shed light on mechanisms are also discussed. Finally, expansion concept by including an assessment cognition, patient-reported outcomes, comorbidities, considered. ANN NEUROL 2020;88:438-452.

Язык: Английский

Процитировано

87
Treatment effects of cladribine tablets on data-driven patterns of regional grey matter atrophy in multiple sclerosis DOI Creative Commons
Mar Barrantes-Cepas, Samantha Noteboom, Elisa Colato

и другие.

Multiple Sclerosis Journal, Год журнала: 2025, Номер unknown

Опубликована: Фев. 25, 2025

Background: Treatment with cladribine tablets (CladT) in relapsing–remitting multiple sclerosis (RRMS) reduced global grey matter (GM) atrophy, but the effects on regional GM are unknown. Objectives: This study aimed to investigate effect of CladT compared placebo magnetic resonance imaging (MRI)-derived patterns atrophy. Methods: We used MRI and clinical data from CLARITY study, including 393 people RRMS (CladT (3.5 mg/kg), n = 200 or placebo, 193) at baseline, 24, 48 96 weeks after treatment initiation. SynthSeg-derived volume changes atrophy derived source-based morphometry were analysed for group differences over time associations disability using mixed-effect models. Results: Deep (β −0.03, p < 0.01), thalamus −0.04, 0.01) brainstem–thalamus pattern 0.05) showed higher reduction treated group. These regions no during a predefined pseudo-atrophy period, where loss was worse Between W24 W96, Expanded Disability Status Scale (EDSS) scores associated lower deep −0.16, 0.001), thalamic −0.12, 0.05). Conclusion: clinically relevant slower neurodegeneration RRMS. Strongest seen GM, thalamus, brainstem, underlining importance measures assessing effects.

Язык: Английский

Процитировано

1
Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials DOI
Ludwig Kappos, Sean Yiu, Frank Dahlke

и другие.

Neurology, Год журнала: 2025, Номер 104(10)

Опубликована: Апрель 21, 2025

Sensitive and meaningful disability worsening measures remain an unmet medical need in multiple sclerosis (MS). Composite confirmed worsening/progression (cCDW/cCDP) combines the Expanded Disability Status Scale (EDSS) with performance tests of ambulation dexterity (Timed 25-Foot Walk Test [T25FWT] Nine-Hole Peg [9HPT]). We assessed relation changes these to understand utility cCDW/cCDP as endpoint for MS trials. Clinical trials measuring all components cCDW were selected analysis (i) individual patient-level data from Roche-sponsored studies characterize association between performance-test subsequent EDSS (ii) population-level published reporting treatment effects on either cCDP or T25FWT 9HPT events examine relationship events. Analysis (i): 6 Phase III comprising 4,979 patients relapsing-remitting (RRMS; n = 1,225), relapsing (RMS; 1,656), progressive (PMS; 922), primary (PPMS; 1,171), a cutoff November 2022, included patient analyses. For trials, associated increased risk (hazard ratios [HRs], p values: 2.11-5.20, 0.07-<0.001); similar associations found HRs later ranging 1.47 2.66 (p values 0.24-<0.001). without first 96 study weeks, weeks (HRs, 1.74-3.26, 0.01-<0.001; 1.45-3.08, 0.45-<0.001). Patients more likely experience ≥8-point change baseline at final visit 29-item Multiple Sclerosis Impact physical subscale (risk ratios, 1.45-2.17, 0.004-<0.001; 1.26-1.87, 0.15-0.03). (ii): In 9 included, predictive (Spearman correlation [95% CI] 0.82 [0.34-0.96], 0.005). this post hoc analysis, was harbinger correlated those EDSS. These results establish validity clinical relevance worsening, thus supporting use outcome progression ClinicalTrials.gov Identifiers: NCT01247324 (OPERA I); submitted 23, 2010; enrolled: August 31, 2011; available clinicaltrials.gov/study/NCT01247324. NCT01412333 II); 8, September 20, clinicaltrials.gov/study/NCT01412333. NCT03085810 (ENSEMBLE); March 16, 2017; 27, clinicaltrials.gov/study/NCT03085810. NCT01194570 (ORATORIO); 28, 3, clinicaltrials.gov/study/NCT01194570. NCT03523858 (CONSONANCE); April 2018; May clinicaltrials.gov/study/NCT03523858. NCT00087529 (OLYMPUS); July 9, 2004; clinicaltrials.gov/study/NCT00087529.

Язык: Английский

Процитировано

1
Real-world keystroke dynamics are a potentially valid biomarker for clinical disability in multiple sclerosis DOI Creative Commons
Ka‐Hoo Lam,

KA Meijer,

Floor C. Loonstra

и другие.

Multiple Sclerosis Journal, Год журнала: 2020, Номер 27(9), С. 1421 - 1431

Опубликована: Ноя. 5, 2020

Background: Clinical measures in multiple sclerosis (MS) face limitations that may be overcome by utilising smartphone keyboard interactions acquired continuously and remotely during regular typing. Objective: The aim of this study was to determine the reliability validity keystroke dynamics assess clinical aspects MS. Methods: In total, 102 MS patients 24 controls were included observational study. Keyboard obtained with Neurokeys app. Eight timing-related features assessed for intraclass correlation coefficients (ICCs); construct analysing group differences (in fatigue, gadolinium-enhancing lesions on magnetic resonance imaging (MRI), vs controls); concurrent correlating disability measures. Results: Reliability moderate two (ICC = 0.601 0.742) good excellent remaining six 0.760–0.965). Patients had significantly higher latencies than controls. Latency between key presses correlated highest Expanded Disability Status Scale ( r 0.407) latency releases Nine-Hole Peg Test Symbol Digit Modalities (ρ 0.503 −0.553, respectively), ps < 0.001. Conclusion: Keystroke reliable, distinguished controls, associated Consequently, are a promising valid surrogate marker

Язык: Английский

Процитировано

43
Ocrelizumab for multiple sclerosis DOI

Mengbing Lin,

Jian Zhang, Yueling Zhang

и другие.

Cochrane library, Год журнала: 2022, Номер 2022(5)

Опубликована: Май 18, 2022

Язык: Английский

Процитировано

24
MRI features suggestive of gadolinium retention do not correlate with Expanded Disability Status Scale worsening in Multiple Sclerosis DOI
Sirio Cocozza, Giuseppe Pontillo, Roberta Lanzillo

и другие.

Neuroradiology, Год журнала: 2019, Номер 61(2), С. 155 - 162

Опубликована: Янв. 8, 2019

Язык: Английский

Процитировано

43
Differentiating societal costs of disability worsening in multiple sclerosis DOI
Nils-Henning Neß, Dirk Schriefer, Rocco Haase

и другие.

Journal of Neurology, Год журнала: 2019, Номер 267(4), С. 1035 - 1042

Опубликована: Дек. 17, 2019

Язык: Английский

Процитировано

39
Prospective trial of natalizumab personalised extended interval dosing by therapeutic drug monitoring in relapsing-remitting multiple sclerosis (NEXT-MS) DOI
Alyssa A Toorop, Zoë YGJ van Lierop, Liza M. Y. Gelissen

и другие.

Journal of Neurology Neurosurgery & Psychiatry, Год журнала: 2023, Номер unknown, С. jnnp - 332119

Опубликована: Ноя. 14, 2023

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 intervals.

Язык: Английский

Процитировано

11