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

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  • معلومة اضافية
    • Contributors:
      Université Côte d'Azur (UniCA); Observatoire Français de la Sclérose En Plaques Lyon (OFSEP); Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL); Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Université de Lyon; Lille Neurosciences & Cognition - U 1172 (LilNCog); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Centre d'Investigation Clinique Rennes (CIC); Université de Rennes (UR)-Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou -Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Hospices Civils de Lyon (HCL); Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Université de Montpellier (UM); Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre Hospitalier Universitaire de Nîmes (CHU Nîmes); Institut de Génomique Fonctionnelle (IGF); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS); Université de Nantes (UN); Centre Hospitalier Universitaire Strasbourg (CHU Strasbourg); Les Hôpitaux Universitaires de Strasbourg (HUS); Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); Neurologie générale et maladies inflammatoires du système nerveux Toulouse; CHU Rouen; Normandie Université (NU); Centre Hospitalier Universitaire de Martinique Fort-de-France, Martinique (CHU de Martinique); Centre Hospitalier Universitaire CHU Grenoble (CHUGA); Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale (U1215 Inserm - UB); Université de Bordeaux (UB)-Institut François Magendie-Institut National de la Santé et de la Recherche Médicale (INSERM); Adaptation, mesure et évaluation en santé. Approches interdisciplinaires (APEMAC); Université de Lorraine (UL); Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon); Centre d'épidémiologie des populations (CEP); Université de Bourgogne (UB)-Centre Régional de Lutte contre le cancer Georges-François Leclerc Dijon (UNICANCER/CRLCC-CGFL); UNICANCER-UNICANCER; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); CHU Amiens-Picardie; CHU Caen; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN); Neuro-Dol (Neuro-Dol); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Hôpital Henri Mondor; Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); Hôpital Raymond Poincaré AP-HP; Maladies et hormones du système nerveux (DHNS); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay; Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); Hôpital de la Timone CHU - APHM (TIMONE); Mayo Clinic Jacksonville; Cerrahpasa Faculty of Medicine; Istanbul University; University of Southern California (USC); Yale School of Medicine New Haven, Connecticut (YSM); University of Texas Southwestern Medical Center Dallas; This study was funded through the Observatoire Français de la Sclérose En Plaques, which is supported by grant ANR-10-COHO-002 provided by the French State and handled by the Agence Nationale de la Recherche within the framework of the Investments for the Future program by the Eugène Devic European Database for Multiple Sclerosis Foundation against multiple sclerosis and by the Aide pour la Recherche sur la Sclérose En Plaques Foundation.; ANR-10-COHO-0002,OFSEP,Observatoire Français de la Sclérose en Plaques(2010)
    • بيانات النشر:
      CCSD
      American Medical Association
    • الموضوع:
      2021
    • Collection:
      Université de Lyon: HAL
    • نبذة مختصرة :
      International audience ; 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 ...
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/34633424; PUBMED: 34633424; PUBMEDCENTRAL: PMC8506228; WOS: 000707431100005
    • الرقم المعرف:
      10.1001/jamanetworkopen.2021.28271
    • الدخول الالكتروني :
      https://hal.science/hal-03414579
      https://hal.science/hal-03414579v1/document
      https://hal.science/hal-03414579v1/file/lebrunfrnay_2021_oi_210822_1632853464.53457.pdf
      https://doi.org/10.1001/jamanetworkopen.2021.28271
    • Rights:
      http://creativecommons.org/licenses/by-nc-nd/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.FAF3377F