Tuesday, October 25, 2011

Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon beta-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study

Background

Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly.

Methods

In this observational study, patients (n=550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score <=4.0]) receiving interferon (IFN) beta-1a therapy (44 or 22 ug subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed.

Results

MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P<0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 ug dose than with the 22 ug dose for T2 lesion volume (-10.2% vs -4.5%, P=0.025) and T1 BH volumes (-7.8% vs +10.3%, P=0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN beta-1a, 44 ug sc tiw, predicted an absence of cognitive impairment at Year 3.

Conclusion

Subcutaneous IFN beta-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 ug over the 22 ug dose; higher-dose treatment also predicted better cognitive outcomes over 3 years.

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