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Gadolinium-enhancing or active T2 magnetic resonance imaging lesions in multiple sclerosis clinical trials?

Department of Neurosciences, Ophthalmology and Genetics, University of Genoa, Genoa, Italy; Magnetic Resonance Research Centre on Nervous System Diseases, University of Genoa, Genoa, Italy

L Roccatagliata

Department of Neurosciences, Ophthalmology and Genetics, University of Genoa, Genoa, Italy; Magnetic Resonance Research Centre on Nervous System Diseases, University of Genoa, Genoa, Italy

GL Mancardi

Department of Neurosciences, Ophthalmology and Genetics, University of Genoa, Genoa, Italy; Magnetic Resonance Research Centre on Nervous System Diseases, University of Genoa, Genoa, Italy

MP Sormani

Department of Health Sciences, Biostatistics Unit, University of Genoa, Genoa, Italymariapia.sormani{at}unige.it

Background

The treatment effects in multiple sclerosis (MS) clinical trials are often estimated by monitoring disease activity by the count of "active" plaques on T2-weighted or gadolinium (Gd)-enhanced T1-weighted magnetic resonance imaging (MRI).

Objective

To evaluate the relationship between the treatment effects estimated on T2-weighted or Gd-enhanced T1-weighted MRI.

Methods

Data were extracted from published randomized clinical trials in relapsing-remitting MS with frequent MRI, reporting both active T2 and Gd-enhancing lesions. A regression analysis was performed between the treatment effects estimated on the two different MRI endpoints.

Results

A strong association was found between the treatment effect on Gd-enhancing lesions and on active T2 lesions (R² = 0.93), and the treatment effect estimates were almost the same (slope = 0.96).

Conclusion

Defining either active T2 or Gd-enhancing lesions as MRI endpoint seems to be not crucial for monitoring MRI activity in MS clinical trials. The choice of the best MRI endpoint should be based on different considerations (e.g., sensitivity, reproducibility, time for assessment, safety, and patients’ comfort). Further monitoring active T2 lesions could allow less expensive trials, without requiring injection of Gd-based contrast agents.

Key Words: clinical trial • gadolinium • magnetic resonance • meta-analysis • multiple sclerosis • randomized controlled trial • relapsing-remitting multiple sclerosis

This version was published on September 1, 2009

Multiple Sclerosis, Vol. 15, No. 9, 1043-1047 (2009)
DOI: 10.1177/1352458509106610


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