Multivariate Proteomic MS Disease Activity Test Results Surfaces Both Individual Patient and Clinical Practice Population Insights

Background: The availability of a validated blood-based assay to quantitatively assess disease activity and progression will significantly advance MS clinical care. Quantitative measurement of the level of disease activity in MS patients can provide insights for individual patients as well as for the entire population of patients within a clinical practice. A Multiple Sclerosis Disease Activity (MSDA) Test that measures the concentrations of 18 proteins used to determine 4 disease pathway scores (immune modulation, neuroinflammation, myelin biology and neuroaxonal integrity) and an overall disease activity score has been both analytically and clinically validated.

Objectives: To evaluate the distributions of the MSDA Test disease activity scores observed in a population of MS patients from a clinical practice (Rocky Mountain Multiple Sclerosis Clinic) in the United States.

Methods: 222 samples from a matched serum-MRI study (e.g. serum draw and contrast enhancing MRI administered within 60 days of one another) were assayed in the MSDA Test. In a separate clinical validation study (that included a subset of these matched serum-MRI study samples among other cohorts) the MSDA test algorithm was found to significantly associate with both clinical and radiographic disease activity endpoints. Thresholds were established for the DA score (scale = 1.0 to 10.0) corresponding to Low, Moderate and High levels of DA based on the presence and count of gadolinium enhanced lesions observed on the associated MRI. The 222 samples were assigned to these 3 disease activity categories based on their observed disease activity score.

Results: Of the 222 samples tested, 142 (64%) were observed to have disease activity scores in the Low category (1.0 to 4.0). 70 samples (32%) were observed to have disease activity scores in the Moderate category (4.5 to 7.0). 10 samples (5%) were observed to have disease activity scores in the High category (7.5 to 10.0).

Conclusions: The samples analyzed in the study reflected a well-controlled population of MS patients. Additional analysis is ongoing to evaluate the individual patient’s disease activity and disease pathway scores relative to their clinical and radiographic disease activity and disease progression endpoints. Furthermore, analysis is being performed to characterize the patient’s DA scores based on their current and previous disease modifying therapeutic history. The results from the MSDA Test can serve as a quantitative and objective tool to evaluate an individual patient’s level of disease activity as well as to monitor the overall level of disease activity within a clinic’s population.