Outcome measures
T2-hyperintense lesions, gadolinium-enhancing lesions, Expanded Disability Status Scale
DISEASE, MULTIPLE SCLEROSIS, SECONDARY
The European Database for Multiple Sclerosis (EDMUS) software was used for the prospective collection of clinical and imaging data [The variables studied included the number of relapses during the two years before STRm and the number of annual relapses after STRm, time to first relapse after STRm and after OCR initiation, the Expanded Disability Status Scale (EDSS) score obtained every 6 months, T2 new hyperintense lesions, and gadolinium-enhancing lesions on the basal MRI prior to STRm and in annual controls after that, plus an additional MRI obtained 3 months before and after OCR initiation. The proportion of patients with no evidence of disease activity (NEDA-3) after 1 year and 2 years of follow-up were evaluated. The NEDA-3 definition used included the absence of relapse, no evidence of increased EDSS (defined as ≥ 1.5-point EDSS increase if EDSS = 0, ≥ 1-point EDSS increase if EDSS 1–5.5, or ≥ 0.5-point EDSS increase if EDSS ≥ 6.0), and no new T2-hyperintense lesions or gadolinium-enhancing lesions on brain MRIs.The primary endpoints were the presence of relapses and the time to first relapse, which were assessed for both groups using surveillance analysis from two different starting points: STRm (which includes the washout period for the JCV + OCR arm) and time of OCR initiation (which excludes the washout period for the JCV + OCR arm). The secondary endpoints were the annualized relapse rate (ARR) one year after STRm and after OCR initiation, and the increase in EDSS score, presence of gadolinium-enhancing or new T2-hyperintense lesions, and the proportion of NEDA one year after STRm.In the multivariate analysis, variables included were sex, age at treatment initiation, treatment (NTZ or OCR), ARR 2 years before STRm, EDSS at STRm, and time on NTZ before STRm.