Magnetic resonance imaging as surrogate for clinical endpoints in multiple sclerosis: data on novel oral drugs

Area of Science:

• Neuroimaging
• Clinical Trials
• Neurology

Background:

• Magnetic resonance imaging (MRI) active lesions are increasingly used as surrogate endpoints for relapses and disability progression in multiple sclerosis (MS).
• The validity of MRI metrics as surrogate endpoints in MS clinical trials remains a subject of debate.
• Previous findings may not be directly applicable to novel therapeutic agents.

Purpose of the Study:

• To evaluate the validity of MRI surrogacy in recent multiple sclerosis (MS) clinical trials involving oral medications.
• To assess the predictive accuracy of MRI active lesions for clinical outcomes in the context of novel oral therapies.

Main Methods:

• Analysis of recently published clinical trials of oral drugs for multiple sclerosis (MS).
• Comparison of observed clinical outcomes with outcomes predicted by MRI active lesions.

Main Results:

• A high degree of concordance was observed between predicted and actual clinical outcomes.
• Approximately 92% of the effects of oral drugs on clinical outcomes aligned closely with predictions based on MRI active lesions.

Conclusions:

• The study provides strong evidence validating the use of MRI active lesions as reliable surrogate endpoints in multiple sclerosis (MS) trials.
• These findings have significant implications for optimizing the design and efficiency of future MS clinical trials, particularly those involving oral therapies.