Magnetic resonance imaging as a surrogate outcome for multiple sclerosis relapses

Area of Science:

• Neurology
• Radiology
• Biostatistics

Background:

• Magnetic resonance imaging (MRI) is a potential surrogate marker for multiple sclerosis (MS) clinical outcomes.
• No validated biological surrogate markers currently exist for MS clinical outcomes.
• Contrast-enhancing lesions (CELs) on MRI indicate active MS disease pathology.

Purpose of the Study:

• To determine if contrast-enhancing lesions (CELs) on MRI can serve as a valid surrogate marker for MS relapses.
• To investigate the concurrent and predictive relationship between CELs and MS relapses.

Main Methods:

• Analysis of data from untreated patients in a clinical trial and natural history database.
• Examined correlations between CEL counts over 6 months and MS relapses over 12 months.
• Assessed both concurrent and predictive relationships between MRI findings and clinical events.

Main Results:

• Correlations between CELs and MS relapses were insufficient to validate CELs as a surrogate marker.
• The study did not meet criteria to proceed to further phases for surrogate validation.
• Results indicate CELs cannot reliably predict MS relapses over the studied timeframes.

Conclusions:

• Confidence intervals exclude CELs as a reliable surrogate for MS relapses.
• Improved datasets and MRI techniques may be needed for future surrogate marker research.
• Further investigation requires exploring a wider range of imaging and clinical hypotheses for surrogacy.