J H Simon1, R P Kinkel2, C Kollman3, P O'Connor4, E Fisher5, X You6, R Hyde7. 1. Portland VA Medical Center, VA Medical Center and Oregon Health Science Center, USA jack.simon1@me.com. 2. Department of Neurosciences, University of California San Diego, USA. 3. Department of Biostatistics, Jaeb Center for Health Research, Tampa, FL, USA. 4. Multiple Sclerosis Clinic, St. Michael's Hospital, Toronto, ON, Canada. 5. Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA. 6. Departments of Biostatistics, Biogen Idec Inc, Cambridge, MA, USA. 7. Global Medical Affairs, Biogen Idec Inc, Cambridge, MA, USA.
Abstract
BACKGROUND:Patients with clinically isolated syndrome (CIS) and characteristic magnetic resonance imaging (MRI) lesions are at high risk for multiple sclerosis (MS). However, patients with a minimal MRI lesion burden (a low T2-hyperintense [low T2] lesion count) may have borderline formal diagnostic criteria, presenting a clinical management challenge. OBJECTIVE: Compare the 10-year disease progression of patients with low and higher T2 lesion counts treated over most intervals. METHODS:CIS patients from the original CHAMPS MS trial were retrospectively assigned to low-T2 (first quartile; 2-8 lesions) or higher-T2 (second through fourth quartiles; ≥ 9 lesions) groups using baseline T2 lesion counts. The 5- and 10-year open-label extension of CHAMPS (CHAMPIONS) evaluated conversion to clinically definite MS (CDMS), MRI activity, relapses, and disability. RESULTS: The vast majority of patients showed new disease activity by MRI and/or clinical criteria at 10 years (low-T2 86%; higher-T2 98%). Fewer low-T2 than higher-T2 patients developed CDMS (40% vs. 63%; p = 0.013); low-T2 patients also had fewer new brain lesions, less brain volume loss, and less disability progression. CONCLUSION:CIS patients with low T2 lesion counts show continued disease activity. However, all assessments of disease progression over 10 years indicated a significantly less severe disease course for low-T2 patients.
RCT Entities:
BACKGROUND:Patients with clinically isolated syndrome (CIS) and characteristic magnetic resonance imaging (MRI) lesions are at high risk for multiple sclerosis (MS). However, patients with a minimal MRI lesion burden (a low T2-hyperintense [low T2] lesion count) may have borderline formal diagnostic criteria, presenting a clinical management challenge. OBJECTIVE: Compare the 10-year disease progression of patients with low and higher T2 lesion counts treated over most intervals. METHODS: CIS patients from the original CHAMPS MS trial were retrospectively assigned to low-T2 (first quartile; 2-8 lesions) or higher-T2 (second through fourth quartiles; ≥ 9 lesions) groups using baseline T2 lesion counts. The 5- and 10-year open-label extension of CHAMPS (CHAMPIONS) evaluated conversion to clinically definite MS (CDMS), MRI activity, relapses, and disability. RESULTS: The vast majority of patients showed new disease activity by MRI and/or clinical criteria at 10 years (low-T2 86%; higher-T2 98%). Fewer low-T2 than higher-T2 patients developed CDMS (40% vs. 63%; p = 0.013); low-T2 patients also had fewer new brain lesions, less brain volume loss, and less disability progression. CONCLUSION: CIS patients with low T2 lesion counts show continued disease activity. However, all assessments of disease progression over 10 years indicated a significantly less severe disease course for low-T2 patients.
Authors: Rachel C Nolan; Steven L Galetta; Teresa C Frohman; Elliot M Frohman; Peter A Calabresi; Carmen Castrillo-Viguera; Diego Cadavid; Laura J Balcer Journal: J Neuroophthalmol Date: 2018-12 Impact factor: 3.042