Risk Factors and Time to Clinical Symptoms of Multiple Sclerosis Among Patients With Radiologically Isolated Syndrome - Université de Rennes Accéder directement au contenu
Article Dans Une Revue JAMA Network Open Année : 2021

Risk Factors and Time to Clinical Symptoms of Multiple Sclerosis Among Patients With Radiologically Isolated Syndrome

1 UniCA - Université Côte d'Azur
2 OFSEP - Observatoire Français de la Sclérose En Plaques [Lyon]
3 CRNL - Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
4 UCBL - Université Claude Bernard Lyon 1
5 LilNCog - Lille Neurosciences & Cognition - U 1172
6 CHU Pitié-Salpêtrière [AP-HP]
7 CIC - Centre d'Investigation Clinique [Rennes]
8 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
9 HCL - Hospices Civils de Lyon
10 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
11 UM - Université de Montpellier
12 Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
13 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
14 IGF - Institut de Génomique Fonctionnelle
15 UN - Université de Nantes
16 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
17 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
18 Neurologie générale et maladies inflammatoires du système nerveux [Toulouse]
19 CHU Rouen
20 CHU de la Martinique [Fort de France]
21 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
22 U1215 Inserm - UB - Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale
23 APEMAC - Adaptation, mesure et évaluation en santé. Approches interdisciplinaires
24 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
25 CEP - Centre d'épidémiologie des populations
26 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
27 CHU Amiens-Picardie
28 CHU Caen
29 Neuro-Dol - Neuro-Dol
30 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
31 Hôpital Henri Mondor
32 CHU de Poitiers - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
33 Hôpital Raymond Poincaré [AP-HP]
34 DHNS - Maladies et hormones du système nerveux
35 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
36 TIMONE - Hôpital de la Timone [CHU - APHM]
37 Mayo Clinic [Jacksonville]
38 Cerrahpasa Faculty of Medicine
39 USC - University of Southern California
40 YSM - Yale School of Medicine [New Haven, Connecticut]
41 University of Texas Southwestern Medical Center [Dallas]
Lydiane Mondot
Bertrand Bourre
  • Fonction : Auteur
Nathalie Derache
  • Fonction : Auteur
Pierre Clavelou
  • Fonction : Auteur
Adil Maarouf

Résumé

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 evaluate the 2-year risk of a clinical event (onset of clinical symptoms of MS) prospectively, identify factors associated with developing an early clinical event, and simulate the sample size needed for a phase III clinical trial of individuals with RIS meeting 2009 RIS criteria. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data on prospectively followed-up individuals with RIS identified at 1 of 26 tertiary centers for MS care in France that collect data for the Observatoire Français de la Sclérose en Plaques database. Participants were aged 10 to 80 years with 2 or more magnetic resonance imaging (MRI) scans after study entry and an index scan after 2000. All diagnoses were validated by an expert group, whose review included a double centralized MRI reading. Data were analyzed from July 2020 to January 2021. EXPOSURE: Diagnosis of RIS. MAIN OUTCOMES AND MEASURES: Risk of clinical event and associated covariates at index scan were analyzed among all individuals with RIS. Time to the first clinical event was compared by covariates, and sample size estimates were modeled based on identified risk factors. RESULTS: Among 372 individuals with RIS (mean [SD] age at index MRI scan, 38.6 [12.1] years), 354 individuals were included in the analysis (264 [74.6%] women). A clinical event was identified among 49 patients (13.8%) within 2 years, which was associated with an estimated risk of conversion of 19.2% (95% CI, 14.1%-24.0%). In multivariate analysis, age younger than 37 years (hazard ratio [HR], 4.04 [95% CI, 2.00-8.15]; P < .001), spinal cord lesions (HR, 5.11 [95% CI, 1.99-13.13]; P = .001), and gadolinium-enhancing lesions on index scan (HR, 2.09 [95% CI, 1.13-3.87]; P = .02) were independently associated with an increased risk of conversion to MS. Having 2 factors at the time of the index MRI scan was associated with a risk of 27.9% (95% CI, 13.5%-39.9%) of a seminal event within 2 years, increasing to 90.9% (95% CI, 41.1%-98.6%) for individuals with all 3 factors (3 risk factors vs none: HR, 23.34 [95% CI, 9.08-59.96]; P < .001). Overall, with 80% power to detect an effect size of 60% within 24 months, a total of 160 individuals with RIS were needed assuming an event rate of 20%. CONCLUSIONS AND RELEVANCE: This study found that age younger than age 37 years, spinal cord involvement, and gadolinium-enhancing lesions on index MRI scan were associated with earlier clinical disease and relevant to the number of enrolled patients needed to detect a potential treatment effect.
Fichier principal
Vignette du fichier
lebrunfrnay_2021_oi_210822_1632853464.53457.pdf (1.08 Mo) Télécharger le fichier
Origine : Fichiers éditeurs autorisés sur une archive ouverte

Dates et versions

hal-03414579 , version 1 (04-11-2021)

Licence

Paternité - Pas d'utilisation commerciale - Pas de modification

Identifiants

Citer

Christine Lebrun-Frénay, Fabien Rollot, Lydiane Mondot, Helene Zephir, Celine Louapre, et al.. Risk Factors and Time to Clinical Symptoms of Multiple Sclerosis Among Patients With Radiologically Isolated Syndrome. JAMA Network Open, 2021, 4 (10), pp.e2128271. ⟨10.1001/jamanetworkopen.2021.28271⟩. ⟨hal-03414579⟩
116 Consultations
63 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More