Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study
Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study
-  To examine short- and long-term value of appearance of new active lesions in predicting
 extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA
 (Avonex- Steroid-Azathioprine)study.

 -  To explore how accumulation of cortical and SDGM atrophy over 5 years differs with
 respect to the number of new active lesions or amount of disease activity, in early
 relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop
 sustained disability progression.

 -  To examine the relationship between development of cortical and SDGM atrophy and
 regional likelihood of development of new active lesions over 5 years.
Historically, MS has been classified as a disease predominantly affecting the white matter
 (WM) of the central nervous system. However, pathological changes in gray matter (GM) are
 increasingly recognized as an important component of the MS disease process. Advances in MRI
 have enabled detection of changes in GM morphology.

 The ASA study was a placebo-controlled trial that evaluated efficacy of Avonex® alone and in
 combination with azathioprine (AZA) or AZA and corticosteroids as initial MS therapy in 181
 patients with early RRMS over 5 years. The study was conducted in the Czech Republic, and all
 clinical and MRI examinations were concluded at 5 years.

 No study has evaluated the evolution of cortical and SDGM atrophy in relation to global or
 regional accumulation of active lesions and/or occurrence of relapses both from predictive
 short- and long-term perspective. The ASA study provides a unique opportunity to
 prospectively study the impact of cortical and SDGM atrophy accumulation on long-term
 disability progression in a defined cohort of early RRMS patients who presented with various
 amount of disease activity, as measured by the appearance of new active lesions and
 occurrence of relapses.

 By assessing lesion activity in the 0-6 and 6-12 months in the ASA study we will be able to
 evaluate predictive value for development of cortical and SDGM atrophy in early RRMS patients
 over 5 years with respect to the number of new active lesions or amount of disease activity
 in the first year. We will also evaluate lesion development from 12-60 months in relation to
 development of cortical and SDGM atrophy. We will also analyze accumulation of cortical and
 SDGM atrophy in early RRMS patients who will or will not develop sustained disability
 progression, based on the number of new active lesions or amount of clinical and MRI disease
 activity in short- and long-term. Regional classification of new active lesions over 5 years
 in cortical, subcortical and fossa posterior will allow prospective examination of cortical
 and SDGM atrophy and appearance of the new lesions.
Inclusion Criteria:

 -  Enrolled into the 2-year, double-blind, placebo-controlled ASA study and entered 3
 year extension study

 -  MRI was performed on all patients using a 1.5 T magnet

 Exclusion Criteria:

 -  MRI images unable to be processed

 -  All 5 MRI time points not collected