Abstract
New treatment options may make “no evidence of disease activity” (NEDA: no relapses or disability progression and no new/enlarging MRI lesions, as opposed to “evidence of disease activity” (EDA) with at least one of the former), an achievable goal in relapsing-remitting multiple sclerosis (RRMS). The objective of the present study was to determine whether early RRMS patients with EDA at one-year follow-up had different disability, cognition, treatment and gray matter (GM) atrophy rates from NEDA patients and healthy controls (HC). RRMS patients (mean age 34 years, mean disease duration 2.2 years) were examined at baseline and one-year follow-up with neurological (n = 72), neuropsychological (n = 56) and structural MRI (n = 57) examinations. Matched HC (n = 61) were retested after three years. EDA was found in 46% of RRMS patients at follow-up. EDA patients used more first line and less second line disease modifying treatment than NEDA (p = 0.004). While the patients groups had similar disability levels at baseline, they differed in disability at follow-up (p = 0.010); EDA patients progressed (EDSS: 1.8–2.2, p = 0.010), while NEDA patients improved (EDSS: 2.0–1.7, p<0.001). Cognitive function was stable in both patient groups. Subcortical GM atrophy rates were higher in EDA patients than HC (p<0.001). These results support the relevance of NEDA as outcome in RRMS and indicate that pathological neurodegeneration in RRMS mainly occur in patients with evidence of disease activity.
Highlights
With the emergence of new disease modifying treatment (DMT) options, “disease activity free status” [1,2] or “no evidence of disease activity” (NEDA) [3] has been introduced as an PLOS ONE | DOI:10.1371/journal.pone.0135974 August 17, 2015Disease Activity in Early multiple sclerosis (MS)
In a previous publication we have shown that the general ability levels of patients and controls were similar, assessed with tests of vocabulary and Female, n (%) Age, years, mean (SD) Education, years, mean (SD) Follow-up period, months, mean (SD)
Lower NEDA rates have been observed in most clinical trials, both for patients receiving DMTs and placebo [2,4,5], while a recent interim report on HDIT/HCT reported 78% NEDA after 3 years [6]
Summary
The objective of the present study was to determine whether early RRMS patients with EDA at one-year follow-up had different disability, cognition, treatment and gray matter (GM) atrophy rates from NEDA patients and healthy controls (HC)
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