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Updated: May 27, 2026
Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla
Published on: February 19, 2021
Evaluation of safety monitoring guidelines based on MRI lesion activity in multiple sclerosis
C A Riddell1, Y Zhao, D K B Li
1Department of Statistics, University of British Columbia, Vancouver, Canada.
Objective:
We evaluate variants of a commonly used data safety monitoring guideline in clinical trials in multiple sclerosis (MS) that flags patients who, at a follow-up visit, have 5 or more contrast-enhancing lesions (CELs) above their baseline count.
Methods:
We apply the guideline to a relapsing cohort and a secondary progressive cohort. We assess the number of patients that meet the guideline and describe the characteristics of these patients; we also examine the value of the guideline in predicting relapse occurrence in the 28 days following that MRI. These analyses were repeated for thresholds varying from 1 to 10 CELs above baseline.
Results:
Between 4% and 6% of patients met the threshold of 5 in both cohorts; patients with higher baseline counts and higher T2 lesion burden were more apt to meet the threshold. After adjustment for other covariates, the odds ratio (OR) of relapse associated with meeting the threshold is significant (p < 0.05) or near significant (0.05 ≤ p < 0.10) for thresholds between 5 and 8 for the relapsing cohort, but not for the secondary progressive cohort. Across thresholds, the adjusted OR is consistently greater than 1, and there is an increasing trend as the threshold increases from 1 to 7.
Conclusions:
A guideline based on crossing a threshold CEL count above baseline may be valuable in monitoring patient safety. Further study should be conducted using different datasets to assess the generalizability of these results.
Insights
A data safety monitoring guideline for multiple sclerosis (MS) clinical trials, flagging patients with 5 or more new contrast-enhancing lesions (CELs), shows potential value in predicting relapses, especially in relapsing MS cohorts.
Area of Science:
- Neurology
- Clinical Trials
- Neuroimaging
Background:
- Clinical trials in multiple sclerosis (MS) require robust data safety monitoring.
- A common guideline flags patients with 5 or more new contrast-enhancing lesions (CELs) above baseline at follow-up visits.
Purpose of the Study:
- To evaluate variants of a data safety monitoring guideline for MS clinical trials.
- To assess the utility of different CEL thresholds in predicting relapse risk.
Main Methods:
- Applied a guideline to relapsing and secondary progressive MS cohorts.
- Assessed patient characteristics meeting the guideline and the guideline's predictive value for relapse within 28 days post-MRI.
- Analyzed varying CEL thresholds from 1 to 10 above baseline.
Main Results:
- 4-6% of patients met the 5-CEL threshold in both cohorts.
- Higher baseline CEL counts and T2 lesion burden were associated with meeting the threshold.
- Significant or near-significant odds ratios for relapse were observed for thresholds between 5 and 8 in the relapsing cohort, but not in the secondary progressive cohort.
Conclusions:
- A guideline based on CEL count thresholds may aid patient safety monitoring in MS trials.
- Further research with diverse datasets is needed to confirm generalizability.
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