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Does Initiation of Disease Modifying Therapy in Patients With Radiologically Isolated Syndrome Reduce their Risk of
Aimen Vanood1, Nicholas L Zalewski1, Lisa A Marks2
1Department of Neurology.
Background:
Radiologically Isolated Syndrome (RIS) is defined as incidentally found MRI abnormalities that are radiographically indistinguishable from multiple sclerosis (MS) and is considered a presymptomatic disease state of MS. Age <37 years, infratentorial or spinal cord lesions, gadolinium-enhancing lesions on index imaging, and positive cerebrospinal fluid oligoclonal bands have been identified as risk factors for conversion to MS. There are no existing guidelines regarding the role of disease-modifying therapy (DMT) in RIS patients.
Objective:
The objective of this study was to critically assess the current evidence regarding the impact of initiating DMT for patients with RIS on the time to first clinical attack of MS.
Methods:
The objective was addressed through the development of a structured critically appraised topic. This included a clinical scenario with a clinical question, literature search strategy, critical appraisal, results, evidence summary, commentary, and bottom-line conclusions. Participants included consultant and resident neurologists, medical librarian, and content experts in the field of neuroimmunology.
Results:
A multicenter, prospective, randomized, double-blind, placebo-controlled trial was chosen for critical appraisal. This trial examined the impact of treatment with dimethyl fumarate (DMF) versus placebo on the risk of conversion from RIS to MS over a 96-week study period. Patients in the DMF arm were found to have an 82% reduction in risk of clinical attack. DMF patients also had a smaller number of new/newly enlarging T2 hyperintense lesions compared with placebo. No subgroup analyses were performed to elucidate risk factors for conversion.
Conclusions:
While initiation of DMT in RIS does appear to reduce the time to first clinical attack of MS, the risk factors that should prompt initiation of DMT in this patient population require further study.
Insights
Initiating disease-modifying therapy (DMT) for Radiologically Isolated Syndrome (RIS) significantly reduces the time to the first clinical attack of multiple sclerosis (MS). Further research is needed to identify specific risk factors guiding DMT initiation in RIS patients.
Area of Science:
- Neuroimmunology
- Radiology
- Clinical Neurology
Background:
- Radiologically Isolated Syndrome (RIS) presents as MRI abnormalities mimicking multiple sclerosis (MS) and is considered a preclinical MS stage.
- Identified risk factors for MS conversion include younger age, specific lesion locations (infratentorial, spinal cord), gadolinium enhancement, and positive cerebrospinal fluid oligoclonal bands.
- Current guidelines for disease-modifying therapy (DMT) in RIS patients are lacking.
Purpose of the Study:
- To evaluate the impact of initiating DMT in RIS patients on the time to the first clinical attack of MS.
- To critically appraise existing evidence on DMT use in the context of Radiologically Isolated Syndrome.
- To inform clinical decision-making regarding early intervention in preclinical MS.
Main Methods:
- A structured critically appraised topic (CAT) methodology was employed.
- Inclusion of a clinical scenario, comprehensive literature search, and critical appraisal of evidence.
- Expert review by neurologists and neuroimmunology specialists.
Main Results:
- A randomized controlled trial demonstrated an 82% risk reduction in clinical attacks for patients treated with dimethyl fumarate (DMF) compared to placebo.
- DMF treatment also led to a decrease in new/enlarging T2 hyperintense lesions.
- No subgroup analyses were conducted to identify specific risk factors for conversion.
Conclusions:
- Initiating DMT in RIS patients appears to delay the first clinical attack of MS.
- Further investigation is required to determine the specific risk factors that should prompt DMT initiation in this population.
- Evidence suggests a potential benefit of early intervention in managing preclinical MS.
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