Risk Factors and Time to Clinical Symptoms of Multiple Sclerosis Among Patients With Radiologically Isolated Syndrome
- Type de publi. : Article dans une revue
- Date de publi. : 01/10/2021
-
Auteurs :
Christine Lebrun-FrénayFabien RollotLydiane MondotHélène ZéphirCeline LouapreEmmanuelle Le PageFrançoise Durand-DubiefPierre M LabaugeCaroline BensaEric ThouvenotDavid A LaplaudJérôme de SèzeJonathan CironBertrand BourrePhilippe CabreOlivier CasezAurélie RuetGuillaume MatheyEric BergerThibault MoreauAbdulatif Al KhedrNathalie DerachePierre ClavelouAnne-Marie GuennocAlain CréangeJean-Philippe NeauAyman TourbahJean-Philippe CamdessanchéAdil MaaroufCeline CallierPatrick VermerschOrhun KantarciAksel SivaChristina AzevedoNaila MakhaniMikael CohenDaniel PelletierDarin OkudaSandra Vukusic
-
Organismes :
Université Côte d'Azur
Observatoire Français de la Sclérose En Plaques [Lyon]
Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
Université Claude Bernard Lyon 1
Université Côte d'Azur
Lille Neurosciences & Cognition - U 1172
CHU Pitié-Salpêtrière [AP-HP]
Centre d'Investigation Clinique [Rennes]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Observatoire Français de la Sclérose En Plaques [Lyon]
Hospices Civils de Lyon
Centre Hospitalier Régional Universitaire [Montpellier]
Université de Montpellier
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Centre Hospitalier Universitaire de Nîmes
Institut de Génomique Fonctionnelle
Université de Nantes
Centre Hospitalier Universitaire [Strasbourg]
Centre Hospitalier Universitaire de Toulouse
Neurologie générale et maladies inflammatoires du système nerveux [Toulouse]
CHU Rouen
Centre Hospitalier Universitaire de Martinique [Fort-de-France, Martinique]
Centre Hospitalier Universitaire [CHU Grenoble]
Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale
Adaptation, mesure et évaluation en santé. Approches interdisciplinaires
Centre Hospitalier Régional Universitaire de Besançon
Centre d'épidémiologie des populations
Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
CHU Amiens-Picardie
CHU Caen Normandie – Centre Hospitalier Universitaire de Caen Normandie
Neuro-Dol
Centre Hospitalier Régional Universitaire de Tours
Hôpital Henri Mondor
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Hôpital Raymond Poincaré [AP-HP]
Maladies et hormones du système nerveux
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
Hôpital de la Timone [CHU - APHM]
Université Côte d'Azur
Lille Neurosciences & Cognition - U 1172
Mayo Clinic [Jacksonville]
Cerrahpasa Faculty of Medicine
University of Southern California
Yale School of Medicine [New Haven, Connecticut]
Université Côte d'Azur
University of Southern California
University of Texas Southwestern Medical Center [Dallas]
Université Claude Bernard Lyon 1
Hospices Civils de Lyon
- Publié dans JAMA Network Open le 29/10/2020
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.
Fichiers liés :
lebrunfrnay_2021_oi_210822_1632853464.53457.pdf
Source