Prognostic factors for multiple sclerosis symptoms in radiologically isolated syndrome
Open accessAbstract
Importance: Understanding the risk factors for symptom development will allow clinicians to stratify people with radiologically isolated syndrome (pwRIS) more effectively and tailor their management strategies accordingly. Objective: To identify prognostic factors at radiologically isolated syndrome (RIS) diagnosis associated with the development of multiple sclerosis (MS) symptoms. Design, Setting, and Participants: This cohort study was performed in samples collected between July 2004 and September 2022 and included 33 MS centers. All pwRIS who meet the 2017 McDonald criteria for dissemination in space with a sample collected near the diagnostic magnetic resonance imaging were included. No patients who met eligibility criteria were excluded. The data were analyzed from July 2024 to November 2024. Exposure: Body fluid biomarkers and environmental factors in pwRIS. Main outcomes and measures: The main outcome was the development of MS symptoms. Analyses involved univariable and multivariable Cox proportional hazards models, including age, sex, and treatment following RIS diagnosis, as additional independent variables. Results: The study included 273 pwRIS (mean age, 38.6 [SD 11.6] years; 207 women [75.8%] and 66 men [24.2%]) with a median follow-up of 5.0 [IQR, 2.5-7.7] years. A total of 101 pwRIS developed MS symptoms (37.0%). The presence of immunoglobulin G oligoclonal bands (OBs) (hazard ratio [HR], 5.09; 95% CI, 2.36-10.97; P < .001), immunoglobulin M OBs (HR, 2.58; 95% CI, 1.61-4.14; P < .001), and a κ free light chain index of 6.1 or more (HR, 2.79; 95% CI, 1.37-5.67; P = .005) were associated with MS symptoms. High cerebrospinal fluid neurofilament light chain (NfL) levels (HR, 1.31; 95% CI, 1.18-1.45; P < .001) and high serum NfL z scores (HR, 1.42; 95% CI, 1.16-1.72; P = .005) were also associated with an increased risk of MS symptoms. In contrast, high anti-cytomegalovirus titers (HR, 0.59; 95% CI, 0.38-0.93; P = .02) and high ultraviolet radiation exposure in the year before (HR, 0.52; 95% CI, 0.37-0.74; P < .001) and the year after (HR, 0.54, 95% CI, 0.38-0.75; P < .001) diagnosis reduced the risk of MS symptoms. For all these prognostic factors, the multivariable analysis yielded similar results. The combination of high serum NfL z scores and positive immunoglobulin G OBs conferred a 5-year risk of clinical symptoms of 58.3% (95% CI, 45.9-67.9). This risk increased to 81.6% (95% CI, 60.9-91.4) in pwRIS who were younger and positive for immunoglobulin M OBs. Conclusions and Relevance: The study elucidates the prognostic factors that significantly impact the risk of developing MS symptoms in pwRIS at diagnosis, thereby, enhancing the potential for tailored clinical interventions.
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The 2024-revised criteria permit a diagnosis of MS in individuals with RIS and in people with non-specific presentations.
“Lastly, the criteria now permit a diagnosis of MS in individuals with incidental MRI findings suggestive of chronic inflammatory demyelination (RIS: radiologically isolated syndrome) and in people with non-specific presentations.8,13”
From Applying the 2024-revised McDonald criteria for multiple sclerosis using conventional diagnostic tools: a single-centre prospective cohort study in Germany (2026) · cites this paper as [13]
The Discussion (page unavailable) says the forthcoming 2024 McDonald criteria will classify many people with RIS who meet the 2017 dissemination-in-space criteria as having MS. The paper’s introductory passage says RIS can include nonspecific symptoms, but it does not say the revised criteria permit MS diagnosis in people with nonspecific presentations more generally. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIntrathecal inflammation is associated with a higher risk of conversion to MS.
“frequently demonstrated intrathecal inflammation, which is associated with a higher risk of conversion to MS.”
From Applying the 2024-revised McDonald criteria for multiple sclerosis using conventional diagnostic tools: a single-centre prospective cohort study in Germany (2026) · cites this paper as [13]
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- Authors
- Fissolo, N., Schaedelin, S., Villar, L. M., Lünemann, J. D., Correale, J., Rejdak, K., Schwab, N., Vilaseca, A., Held, F., García-Merino, A., Bittner, S., Trojano, M., Furlan, R., Tumani, H., Pérez-Miralles, F., Rosenstein, I., Galimberti, D., Álvarez-Bravo, G., Thouvenot, E., Llufriu, S., Khoury, S. J., Hoepner, R., Martínez-Yélamos, S., Hegen, H., Drulovic, J., Téllez-Lara, N., Khalil, M., Oechtering, J., Pérez-Sempere, Á., Rodríguez-Antigüedad, A., Enrique-Martínez, J., Strijbis, E., Killestein, J., Eichau, S., Colombo, E., Schaller-Nagengast, J., Midaglia, L., Sánchez-López, A. J., Monreal, E., Chan, A., Paul, F., Rovira, À., Tintoré, M., Lycke, J., Zipp, F., Hemmer, B., Kuhle, J., Montalban, X., Comabella, M., & RIS Study Group
- Affiliations
- Universitat Autònoma de Barcelona (ES)
- Translational Imaging in Neurology (ThINK) Basel, Department of Biomedical Engineering, Faculty of Medicine, University Hospital Basel and University of Basel, Basel, Switzerland
- Instituto Ramón y Cajal de Investigación Sanitaria (ES)
- University Hospital Münster (DE)
- Consejo Nacional de Investigaciones Científicas y Técnicas (AR)
- Medical University of Lublin (PL)
- TUM Klinikum (DE)
- Neuroimmunology Unit, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- University of Bari Aldo Moro (IT)
- IRCCS Ospedale San Raffaele (IT)
- University Hospital Ulm (DE)
- Neuroinmunology Unit, University and Polytechnic La Fe Hospital, Valencia, Spain
- University of Gothenburg (SE)
- University of Milan (IT)
- Institut d'Investigació Biomèdica de Girona (ES)
- Department of Neurology, Nîmes University Hospital, Nîmes, France
- Service of Neurology, Laboratory of Advanced Imaging in Neuroimmunological Diseases, Center of Neuroimmunology, Hospital Clínic of Barcelona, Institut d’Investigacions Biomèdiques, Barcelona, Spain
- American University of Beirut Medical Center (LB)
- University of Bern (CH)
- Multiple Sclerosis Unit, Department of Neurology, Hospital Universitari de Bellvitge. Neurology and Neurogenetics Group, Neuroscience Program, Institut d’Investigació Biomèdica de Bellvitge (IDIBELL), Department of Clinical Sciences, School of Medicine, Universitat de Barcelona (UB), L’Hospitalet de Llobregat, Spain
- Innsbruck Medical University (AT)
- Univerzitetski Klinički Centar Srbije (RS)
- Department of Neurology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
- Medical University of Graz (AT)
- University of Basel (CH)
- Hospital General Universitario de Alicante, Alicante, Spain
- Neurology Department, Cruces-BioCruces Bizkaia University Hospital, Barakaldo-Bizkaia, Spain
- Neurology Department, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain
- Amsterdam Neuroscience (NL)
- Hospital Universitario Virgen Macarena (ES)
- Multiple Sclerosis Centre, IRCCS Mondino Foundation, Pavia, Italy
- Universidad de Alcalá (ES)
- Max Delbrück Center (DE)
- Universitat de Vic - Universitat Central de Catalunya (ES)
- Department of Neurology, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland
- Servei de Neurologia and Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Institut de Recerca Vall d’Hebron (VHIR), Hospital Universitari Vall d’Hebron. Universitat Autònoma de Barcelona, Barcelona, Spain
- University of Rostock (DE)
- ORCID
- Fissolo, Nicolás
- Villar, Luisa M.
- Lünemann, Jan D.
- Correale, Jorge
- Rejdak, Konrad
- Schwab, Nicholas
- Vilaseca, Andreu
- Held, Friederike
- Bittner, Stefan
- Trojano, María
- Furlan, Roberto
- Tumani, Hayrettin
- Rosenstein, Igal
- Galimberti, Daniela
- Álvarez-Bravo, Gary
- Khoury, Samia J.
- Hoepner, Robert
- Hegen, Harald
- Drulovic, Jelena
- Khalil, Michael
- Oechtering, Johanna
- Strijbis, Eva
- Killestein, Joep
- Eichau, Sara
- Colombo, Elena
- Midaglia, Luciana
- Monreal, Enric
- Chan, Andrew
- Paul, Friedemann
- Rovira, Àlex
- Tintoré, Mar
- Lycke, Jan
- Zipp, Frauke
- Hemmer, Bernhard
- Comabella, Manuel
- Venue
- JAMA Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2025-07-01
- Volume
- 82
- Issue
- 7
- Pages
- 722
- ISSN
- 2168-6149 (ISSN-L)
- OpenAlex
- W4410955176
- Cited by
- 27
- References
- 31
- Citations by year
- 2026: 21 · 2025: 6
- FWCI
- 17.95
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- other-oa
- Locations
- JAMA Neurology (publishedVersion)
- PubMed (publishedVersion)
- MDC Repository (Max-Delbrueck-Center for Molecular Medicine) (acceptedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- PubMed Central (submittedVersion)
- Repository of Digital Objects for Teaching Research and Culture (University of Valencia) (submittedVersion, other-oa)
- Open Access CRIS of the University of Bern
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Sanofi
- Massachusetts General Hospital
- Biogen
- Teva Pharmaceutical Industries
- Alexion Pharmaceuticals
- Celgene
- F. Hoffmann-La Roche
- Hexal AG
- American University of Beirut
- CSL Behring
- University of Victoria
- University of Bern
- Merck KGaA
- TG Therapeutics
- Mylan
- International Progressive MS Alliance
- Inselspital, Universitätsspital Bern
- Universitätsmedizin Göttingen
- Amsterdam University Medical Centers
- Horizon Therapeutics
- Multiple Sclerosis Society
- European Commission
- National Research Foundation
- Deutsche Forschungsgemeinschaft
- Institut National de la Santé et de la Recherche Médicale
- Vrije Universiteit Amsterdam
- Bundesministerium für Bildung und Forschung
- Centre National de la Recherche Scientifique
- Universitat de Barcelona
- Universidad de Alcalá
- Karl-Franzens-Universität Graz
- Medizinische Universität Innsbruck
- Medizinische Universität Graz
- Universitat Autònoma de Barcelona
- Universität Innsbruck
- Ipsen
- Neuraxpharm
- MedDay Pharmaceuticals
- Amsterdam Neuroscience
- Samsung
- EMD Serono
- Chugai Pharmaceutical
- Sanofi Genzyme
- Instituto de Salud Carlos III
- NIH Clinical Center
- Cilag
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
- Health Sciences › Medicine › Family Practice › Clinical Reasoning and Diagnostic Skills
- Keywords
- radiologically isolated syndrome, multiple sclerosis, symptom onset, prognostic factors, oligoclonal bands, free light chains, neurofilament light chain, cerebrospinal fluid biomarkers, serum biomarkers, dissemination in space, risk stratification, disease progression prediction, environmental risk factors, alcohol consumption, physical activity
- MeSH terms
- Adult, Demyelinating Diseases, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Prognosis, Risk Factors, Cohort Studies, Biomarkers, Oligoclonal Bands
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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