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Introduction
Skills and Expertise
Publications
Publications (699)
Background
Siponimod is a sphingosine 1-phosphate receptor modulator approved for active secondary progressive multiple sclerosis (aSPMS) in most countries; however, phase 3 EXPAND study data are from an SPMS population with/without disease activity. A need exists to characterize efficacy/safety of siponimod in aSPMS.
Methods
Post hoc analysis of...
Background
In the Phase 3 EXPAND study, siponimod reduced the Neurostatus-EDSS-measured risk of 3/6-month (M) confirmed disability progression versus placebo by 21%/26%, with more pronounced effects (31%/37%) in active SPMS (aSPMS). Here we evaluated the contribution of the Ambulation Score (AS) to measuring siponimod’s effect on disability progres...
What is this summary about?
This article summarizes the findings from a previously published article in Current Medical Research and Opinion. Cladribine tablets are an oral treatment for relapsing multiple sclerosis (shortened to MS), that are given for 4 periods of 4 to 5 days over 2 years (for a total of 20 days). In this analysis, researchers lo...
Background and objectives:
The onset of action for high-efficacy immunotherapies in multiple sclerosis (MS) is an important parameter. This study (MAGNIFY-MS) evaluates the onset of action of cladribine tablets by observing changes in combined unique active (CUA) MRI lesion counts during the first 6 months of treatment in patients with highly acti...
Background and Objectives
Masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (MS). Study AB07002 assessed oral masitinib in patients with progressive MS who were progressing but not clinically active.
Methods
This ra...
Background
Siponimod significantly reduced the risk of confirmed disability progression (CDP), worsening in cognitive processing speed (CPS), relapses, and magnetic resonance imaging (MRI) measures of brain atrophy and inflammation versus placebo in secondary progressive multiple sclerosis (SPMS) patients in the Phase 3 EXPAND study.
Objective
The...
Les avancées thérapeutiques dans la sclérose en plaques (SEP) ont été importantes ces 3 dernières décennies. Les progrès en immunologie, la collaboration entre le milieu académique et industriel y ont contribué largement. La radiologie et plus spécialement l’imagerie par résonance nucléaire a bien montré, avec la clinique, l’effet de différents tra...
Introduction
Les fumarates présentent un profil bénéfice-risque favorable chez les patients atteints de sclérose en plaques récurrente-rémittente (SEP-RR). Une lymphopénie sévère et prolongée apparaît chez 2,2 % des patients.
Objectifs
L’objectif principal de LymphoTEC, étude rétrospective et multicentrique, est de décrire la reconstitution lympho...
Introduction
L’étude de phase IIIb CASTING évalue l’efficacité et la tolérance d’OCR chez des patients (pts) SEP-RR ayant une réponse sous-optimale à 1 ou 2 DMT pris ≥ 6 mois. LIBERTO est une étude d’extension ouverte dans laquelle les pts de CASTING peuvent être inclus.
Objectifs
Évaluer l’efficacité et la tolérance d’OCR à 3 ans chez les pts att...
Introduction
À l’issue d’un traitement de première ligne de la SEP un choix s’offre entre traitement de seconde ligne ou prescription d’un autre traitement de première ligne.
Objectifs
Décrire les modifications de traitement survenant en vie réelle après une première ligne de traitement de fond pour une SEP-RR.
Patients et méthodes
L’étude a été...
Introduction
La SEP-pédiatrique représente environ 5 % des cas. Son évolution est souvent plus active que chez l’adulte. Le profil d’efficacité et sécurité du DMF, établi chez l’adulte, est inconnu chez l’enfant.
Objectifs
L’étude CONNECT a comparé l’efficacité et la sécurité du DMF et de l’interféron bêta-1a (IFNβ-1a) intramusculaire chez des pat...
Background
Magnetic resonance imaging (MRI) measurements of gray matter (GM) atrophy and magnetization transfer ratio (MTR; correlate of myelination) may provide better insights than conventional MRI regarding brain tissue integrity/myelination in multiple sclerosis (MS).
Objective
To examine the effect of siponimod in the EXPAND trial on whole-br...
On 12 September 2019, the global Patient Reported Outcome for Multiple Sclerosis (PROMS) Initiative was launched at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis Internat...
Introduction:
It is important to confirm the effectiveness and tolerability of disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS) in real-world treatment settings. This prospective observational cohort study (VIRGILE) was performed at the request of the French health authorities. The primary objective was to evaluate th...
Background:
Cognitive deficits are common in multiple sclerosis (MS) and affect patients at all stages of the disease, regardless of phenotype.
Aims:
This literature review focuses the cognitive deficits observed in secondary progressive MS (SPMS). It is mainly based on studies that compared the frequency and main characteristics of cognitive de...
Cladribine tablets (CladT) preferentially reduce B and T lymphocyte levels. As aging is associated with a decline in immune function, the effect of CladT on lymphocyte levels may differ by age. This post hoc analysis combined data from the Phase 3 CLARITY, CLARITY Extension, and ORACLE-MS studies to examine the effect of age (≤50 or >50 years) on l...
Introduction
Recent studies suggested that anti-CD20 and fingolimod may be associated with lower anti-spike protein-based immunoglobulin-G response following COVID-19 vaccination. We evaluated if COVID-19 occurred despite vaccination among patients with multiple sclerosis (MS) and neuromyelitis optica (NMO), using the COVISEP registry.
Case series...
Does preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35.4%) patients with and 395/1120 (35.3%) without preexisting autoimmunity developed non-MS autoimmunity. Thyroid autoimmun...
Background
Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID-19 pandemic, in particular relating to COVID-19 vaccination.
Objective
We describe a consensus-based program led by international MS experts with the aim o...
Objective
To evaluate changes over 3 years in the thickness of inner retinal layers including the peripapillary retinal nerve fiber layer (pRNFL), and combined macular ganglion cell and inner plexiform layers (mGCIPL), in individuals with relapsing-remitting multiple sclerosis (RRMS) versus healthy controls; to determine whether optical coherence t...
Background
Using the treatment goal of ‘no evidence of disease activity’ (NEDA) incorporating MRI rebaselining, we assessed the efficacy of ocrelizumab in patients with relapsing–remitting multiple sclerosis with a prior suboptimal response, defined by MRI or relapse criteria, to one or two disease-modifying therapies (DMTs).
Methods
CASTING was a...
Introduction: Younger age, oligoclonal bands, infratentorial, and presence of spinal cord lesions are factors associated with an increased 10-year risk of clinical conversion from radiologically isolated syndrome (RIS). Whether disease-modifying therapy is beneficial in RIS remains currently unknown. Objectives: To evaluate the 2-year risk of a cli...
Background:
No evidence of disease activity (NEDA-3) is a patient-centric outcome increasingly used as the goal of multiple sclerosis treatment.
Objective:
Determine treatment durability of cladribine tablets beyond 2 years considering the variable bridging interval of 0.1-116.0 weeks between CLARITY and CLARITY Extension.
Methods:
Between CLA...
Importance:
Younger age, oligoclonal bands, and infratentorial and spinal cord lesions are factors associated with an increased 10-year risk of clinical conversion from radiologically isolated syndrome (RIS) to multiple sclerosis (MS). Whether disease-modifying therapy is beneficial for individuals with RIS is currently unknown.
Objectives:
To e...
Background Tolebrutinib is an oral, CNS-penetrant, irreversible inhibitor of Bruton's tyrosine kinase, an enzyme expressed in B lymphocytes and myeloid cells including microglia, which are major drivers of inflammation in multiple sclerosis. We aimed to determine the dose-response relationship between tolebrutinib and the reduction in new active br...
Background
Tolebrutinib is an oral, CNS-penetrant, irreversible inhibitor of Bruton’s tyrosine kinase, an enzyme expressed in B lymphocytes and myeloid cells including microglia, which are major drivers of inflammation in multiple sclerosis. We aimed to determine the dose-response relationship between tolebrutinib and the reduction in new active br...
Background
Interventions targeting the adaptive immune response are needed in multiple sclerosis (MS).
Objective
Evaluate laquinimod’s efficacy, safety, and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS).
Methods
CONCERTO was a randomized, double-blind, placebo-controlled, phase-3 study. RRMS patients were randomized...
Introduction:
In the Cladribine Tablets Treating Multiple Sclerosis Orally (CLARITY) study, cladribine tablets significantly reduced relapse rates and improved findings on magnetic resonance imaging versus placebo in patients with relapsing multiple sclerosis. In the CLARITY Extension study, treatment with cladribine tablets for 2 years followed b...
Background
Gait initiation is an automatized motor program that is preceded by anticipatory postural adjustments (APAs). During attentional tasks, these APAs can be modulated, producing multiple APAs. However, the role of the peripheral nervous system in the regulation of these APAs is unknown.
Research question
The objective of our study was to i...
Objectives:
The study aimed to assess the potential for serum neurofilament light chain (NFL) levels to predict the risk of progressive multifocal leukoencephalopathy (PML) in natalizumab (NTZ)-treated patients with multiple sclerosis (MS) and to discriminate PML from MS relapses.
Methods:
NFL levels were measured with single molecule array (Sim...
Background: It is thought that older patients with multiple sclerosis (MS) may present with a different clinical disease phenotype, and therefore respond to subcutaneous interferon beta-1a (sc IFN β-1a) differently to younger patients. However, few real-world data are available concerning the effectiveness of sc IFN β-1a according to age. Using dat...
Background
Evidence suggests that efficacy and safety of disease-modifying treatments for multiple sclerosis may differ with age. We evaluate efficacy and safety of teriflunomide across age subgroups of patients from pooled clinical trials and real-world studies.
Methods
Post hoc analyses of patients who received teriflunomide 14 mg in the pooled...
Background: Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID 19 pandemic, in particular relating to COVID 19 vaccination.
Objective: We describe a consensus-based programme led by international MS experts with the ai...
Introduction:
In the 2-year CARE-MS trials (NCT00530348; NCT00548405) in patients with relapsing-remitting multiple sclerosis, alemtuzumab showed superior efficacy versus subcutaneous interferon beta-1a. Efficacy was maintained in two consecutive extensions (NCT00930553; NCT02255656). This post hoc analysis compared disability outcomes over 9 year...
Background:
In multiple sclerosis (MS), the prevalence of alexithymia, defined as an inability to identify and describe emotions, is close to 50% but the prevalence of this symptom in clinically isolated syndrome (CIS) is unknown. Characterizing alexithymia at an early stage of the disease can help to clarify psychobehavioural disturbances in CIS...
Artificial intelligence (AI)-based diagnostic algorithms have achieved ambitious aims through automated image pattern recognition. For neurological disorders, this includes neurodegeneration and inflammation. Scalable imaging technology for big data in neurology is optical coherence tomography (OCT). We highlight that OCT changes observed in the re...
BACKGROUND
A digital tool (Multiple Sclerosis Progression Discussion tool, MSProDiscuss) was developed to facilitate a discussion between a healthcare professional (HCP) and patient in evaluating early, subtle signs of multiple sclerosis (MS) disease progression.
OBJECTIVE
To report findings on the usability and usefulness testing of the MSProDisc...
Background
A digital tool, Multiple Sclerosis Progression Discussion Tool (MSProDiscuss), was developed to facilitate discussions between health care professionals (HCPs) and patients in evaluating early, subtle signs of multiple sclerosis (MS) disease progression.
Objective
The aim of this study is to report the findings on the usability and usef...
Introduction
L’étude de phase IIIb CASTING évalue l’efficacité d’OCR sur l’activité de la maladie et sa tolérance chez les patients (pts) atteints de SEP-RR qui ont eu une réponse inadéquate à 1 ou 2 DMTs antérieur(s) (1/2 DMT).
Objectifs
Présenter les résultats à 2 ans de l’efficacité d’OCR sur l’absence d’activité de la maladie évaluée avec le s...
Introduction
SymptoMScreen est un outil d’évaluation utilisé dans l’étude CASTING en cours, étude de phase IIIb à un seul bras, menée en ouvert chez des patients (pts) atteints de SEP-RR qui ont eu une réponse sous-optimale à 1 ou 2 DMT antérieur.
Objectifs
Présenter l’évolution des scores SymptoMScreen rapportés par les pts sur l’évaluation de 12...
Introduction
Une étude récente a montré que les traitements oraux amélioraient, en vie réelle, le maintien et l’observance du traitement par rapport aux injectables chez les patients naïfs atteints de SEP.
Objectifs
Un des objectifs de cette étude consistait à décrire le parcours et les consommations de soins des patients en première ligne de trai...
Introduction
La sclérose en plaques (SEP) est une cause majeure de diminution de la capacité à travailler. Natalizumab est associé à une amélioration de la productivité dans des études observationnelles précédentes.
Objectifs
Évaluer l’impact du natalizumab sur l’évolution de la productivité au travail de patients actifs atteints de SEP RR en Fran...
Introduction
Plusieurs évaluations de routine (EDSS, poussées, IRM) sont prédictives de l’efficacité des traitements dans la sclérose en plaques récurrente-rémittente (SEP RR). Cependant, une évaluation multimodale fine a peu été étudiée.
Objectifs
Évaluer l’intérêt de plusieurs évaluations non pratiquées en routine sur le recours à un traitement...
Introduction
La fatigue est fréquente chez les patients atteints de sclérose en plaques (SEP) et altère la qualité de vie. Si certaines hypothèses éthio-pathogéniques ont été avancées aucune n’a été validée.
Objectifs
L’objectif de cette étude est de rechercher un lien entre la fatigue, les habitudes alimentaires et l’état nutritionnel des patient...
Background:
Disease modifying therapies (DMTs), have an impact on relapses and disease progression. Nonetheless, many patients with multiple sclerosis (pwMS) remain untreated. The objective of the present study was to determine the proportion of untreated patients with multiple sclerosis (pwMS) followed in expert centers in France and determine th...
The Multiple Sclerosis Data Alliance (MSDA), a global multi-stakeholder collaboration, is working to accelerate research insights for innovative care and treatment for people with multiple sclerosis (MS) through better use of real-world data (RWD). Despite the increasing reliance on RWD, challenges and limitations complicate the generation, collect...
Background : Relapsing–remitting multiple sclerosis (RRMS) patients with high disease activity (HDA) experience more severe disease than those without HDA. This analysis describes the efficacy of cladribine tablets 3.5 mg/kg in HDA patient subgroups that were either treated with disease-modifying drugs (DMDs) prior to study entry or were treatment...
Objective:
To investigate the effects of siponimod on cognitive processing speed (CPS) in secondary progressive (SP) multiple sclerosis (MS) patients, by means of a pre-defined exploratory, and post-hoc analysis of the EXPAND study, a randomized controlled trial (RCT) comparing siponimod and placebo.
Methods:
EXPAND was a double-blind, placebo-c...
Background
In the Phase 3, 96-week ORACLE-MS study, cladribine 10 mg tablets (3.5 mg/kg or 5.25 mg/kg cumulative dose over 2 years) significantly reduced the rate of conversion to clinically definite multiple sclerosis (CDMS) per the Poser criteria (henceforth referred to as CDMS), multiple sclerosis (MS) per the 2005 McDonald criteria, and the num...
Background
In multiple sclerosis, impact of treatment on disability progression can be confounded if treatment also reduces relapses.
Objective
To distinguish siponimod’s direct effects on disability progression from those on relapses in the EXPAND phase 3 trial.
Methods
Three estimands, one based on principal stratum and two on hypothetical scen...
Background:
There are few head-to-head studies to compare highly active treatments in multiple sclerosis (MS).
Objective:
The aim of this study was to compare the effectiveness between natalizumab (NTZ) and fingolimod (FTY) in active relapsing-remitting MS.
Method:
Best Escalation STrategy in Multiple Sclerosis (BEST-MS) is a multicentric, pro...
Background:
In this pooled, post hoc analysis of a phase 2 trial and the phase 3 TEMSO, TOWER, and TENERE clinical trials, long-term efficacy and safety of teriflunomide were assessed in subgroups of patients with relapsing multiple sclerosis (MS) defined by prior treatment status.
Methods:
Patients were classified according to their prior treat...
High-dose biotin (HDB) is a therapy used in non-active progressive multiple sclerosis (PMS). Several reports have suggested that HDB treatment may be associated with an increased risk of relapse. We aimed to determine whether HDB increases the risk of clinical relapse in PMS and describe the characteristics of the patients who experience it. We con...
Background:
Little is known about the use of first-line treatments for relapsing-remitting multiple sclerosis (RRMS), whether oral (teriflunomide and dimethyl fumarate) or injectable (interferons/glatiramer acetate [GA]) in France. We conducted an observational study to determine patient profile, persistence and compliance to first-line disease-mo...
Introduction
Cladribine 10 mg (dose cumulée de 3,5 mg/kg [CT3,5] sur 2 ans) a montré une efficacité versus placebo chez les patients atteints de sclérose en plaques récurrente-rémittente dans l’étude CLARITY (NCT00213135).
Objectifs
Analyse post-hoc pour évaluer les résultats d’efficacité chez les patients ayant précédemment utiliser un traitement...
Introduction
L’Evobrutinib, inhibiteur de la tyrosine kinase de Bruton (BTK), a démontré une efficacité clinique dans le traitement de la sclérose en plaques (SEP) au cours d’une étude de phase 2.
Objectifs
Étudier l’effet de l’Evobrutinib sur les cellules immunitaires et les immunoglobulines (Ig) sur une période de 48 semaines.
Patients et métho...
Introduction
La satisfaction des patients est importante pour assurer l’adhésion thérapeutique. Dans CASTING, les pts avec SEP-RR, en réponse sous-optimale à un DMT et traités par OCR ont rempli un questionnaire de satisfaction sur 1 an.
Objectifs
Rapporter les changements de l’autoévaluation sur la satisfaction au traitement entre l’inclusion (BL...
Introduction
L’arsenal thérapeutique s’est enrichi dans le traitement des formes actives de sclérose en plaques (SEP), mais très peu d’études comparent les molécules de manière prospective.
Objectifs
L’étude BEST-MS a démarré en 2013 pour comparer de manière prospective l’efficacité de deux principales molécules disponibles à cette date pour les f...
Introduction
Les pts atteints de SEP-RR ont souvent une activité de la maladie malgré un DMT. L’étude de phase IIIb CASTING évalue l’efficacité/tolérance d’OCR chez les pts atteints de SEP-RR avec réponse inadéquate à 1/2 DMTs.
Objectifs
Présenter les Résultats intermédiaires à 1 an sur l’absence d’activité de la maladie (NEDA ; critère principal)...
Introduction
Par voie orale, cladribine 10 mg, dose cumulative de 3,5 mg/kg (CT3.5) sur 2 ans, est efficace versus placebo chez les patients atteints de sclérose en plaques (SEP) récurrente (CLARITY).
Objectifs
Explorer en post-hoc, la relation entre le score EDSS en début de traitement et le risque de progression en SEP secondairement progressive...
Objective
To evaluate the ability of intereye retinal thickness difference (IETD) measured by optical coherence tomography (OCT) to detect asymptomatic optic nerve involvement in clinically isolated syndrome (CIS).
Methods
We conducted a cross-sectional study of patients who recently presented a CIS (≤4.5 months). All patients underwent OCT and br...
Background:
Data are needed on long-term effect of natalizumab (NTZ) in relapsing-remitting multiple sclerosis (RRMS).
Objectives:
To evaluate the time of onset of secondary progressive phase in patients with an RRMS treated with NTZ and to investigate predictive factors.
Methods:
TYSTEN is an observational study. Patients starting NTZ between 20...