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Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
Published on: July 27, 2018
Personalized activity index, a new safety monitoring tool for multiple sclerosis clinical trials
Yinshan Zhao1, Yumi Kondo2, Anthony Traboulsee3
1MS/MRI Research Group, University of British Columbia, Vancouver, Canada.
Background:
An abnormal increase of contrast-enhancing lesion (CEL) counts on frequent MRIs is interpreted as a signal of potential worsening in multiple sclerosis (MS) clinical trials. We demonstrate the utility of the MR personalized activity index (MR-pax) to identify such increases.
Methods:
We analyzed a previous Phase II study in relapsing patients (n = 167) with MRIs at screening, baseline and months 1-6. We performed five consecutive reviews at 90-day intervals. At each review, we evaluate the MR-pax for each patient and also identify those who meet the rule-of-five (an ad-hoc guideline currently in use). To evaluate its clinical relevance, we assess the relation between having a small MR-pax (≤0.05; indicating an unexpected CEL increase) and relapse status in the 12 weeks post-review.
Results:
Of the 399 patient reviews, 35 cases met the rule-of-five; 35 had an MR-pax ≤ 0.05; 18 met both criteria. The proportions experiencing clinical relapse are 63% among those meeting the rule-of-five, 61% among those with MR-pax ≤0.05, and 83% for those meeting both criteria, more than double the rate of those meeting neither criterion (40%).
Conclusion:
A guideline combining this new personalized index and the existing threshold-based criterion is able to better identify patients with a higher risk of experiencing relapses.
Insights
The MR-personalized activity index (MR-pax) combined with the rule-of-five guideline better identifies multiple sclerosis patients at higher risk for relapse. This approach improves upon existing methods for detecting disease worsening in clinical trials.
Area of Science:
- Neurology
- Radiology
- Clinical Trials
Background:
- Contrast-enhancing lesion (CEL) counts on serial MRIs are used to monitor multiple sclerosis (MS) activity in clinical trials.
- An abnormal increase in CELs often signals potential disease worsening.
- The MR-personalized activity index (MR-pax) offers a novel approach to identify such increases.
Purpose of the Study:
- To evaluate the utility of the MR-pax in identifying increases in CELs.
- To assess the clinical relevance of MR-pax in predicting relapse risk.
- To compare MR-pax with the existing rule-of-five guideline.
Main Methods:
- Analysis of a Phase II clinical trial dataset (n=167) with MRIs at multiple time points.
- Consecutive reviews at 90-day intervals evaluating MR-pax and the rule-of-five criterion.
- Correlation of MR-pax (≤0.05 indicating unexpected CEL increase) and rule-of-five status with 12-week post-review relapse rates.
Main Results:
- Out of 399 reviews, 35 met the rule-of-five, 35 had MR-pax ≤0.05, and 18 met both.
- Relapse rates were 63% for rule-of-five, 61% for MR-pax ≤0.05, and 83% for both criteria.
- Patients meeting both criteria had more than double the relapse rate (83%) compared to those meeting neither (40%).
Conclusions:
- A combined guideline using MR-pax and the rule-of-five criterion enhances the identification of patients at higher risk of relapse.
- This integrated approach provides a more sensitive measure of disease activity in MS clinical trials.
- The MR-pax demonstrates significant clinical relevance in predicting future relapses.
