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BackgroundIn a pooled analysis of patients with relapsing multiple sclerosis in the Phase III OPERA I and OPERA II (NCT01247324/NCT014112333) studies, ocrelizumab increased the proportion of patients with no evidence of disease activity (NEDA) vs interferon β−1a (IFNβ1a); post hocsubgroup analyses are reported here.MethodsNEDA (no 12 week confirmed disability progression, relapse, new/enlarging T2 lesions or T1 gadolinium enhancing lesions) rates were compared by Cochran–Mantel–Haenszel test on the pooled modified intent-to-treat (mITT) population (ocrelizumab, n=761 [600 mg intravenously every 24 weeks]; IFNβ1a, n=759 [44 μg subcutaneously three times weekly]; excludes patients with NEDA discontinuing for reasons unrelated to efficacy).ResultsTreatment benefit for NEDA in the mITT population with ocrelizumab vs IFNβ1a (47.7% vs 27.1%; p<0.001) was maintained across subgroups (ocrelizumab/IFNβ1a; p<0.001 unless stated): age (<40 years: 44.3%/22.6%; ≥40 years: 52.8%/33.7%), gender (male: 44.0%/22.2%; female: 49.7%/29.6%), prior [last 2 years] disease-modifying therapy (yes: 42.8%/23.9%; no: 49.5%/28.3%), prior relapses [last 12 months] (≤1: 49.2%/29.2%; ≥2: 44.2%/22.6%), baseline T1 Gd-enhancing lesions (none: 59.6%/38.8%; ≥1: 30.1%/10.2%) and baseline EDSS score (EDSS <2.5/<4.0: ocrelizumab 50.5%/50.3%, IFNβ1a 27.5%/26.4%; EDSS ≥2.5/≥4.0: ocrelizumab 46.0%/39.6%, IFNβ1a 26.9%/29.4% [NB: EDSS score ≥4: ocrelizumab/IFNβ1a p=0.043]).ConclusionsSubgroup analyses were consistent with those of the overall pooled population on maintaining NEDA status.

BackgroundThe time constraint of NHS care is difficult to reconcile with the comprehensive neurological assessment required to complete a mandatory EDSS for NHS England funded disease modifying treatment of people with multiple sclerosis (pwMS). We report our experience with parametric data collection in order to (i) inform DMT decisions and (ii) improve characterisation for recruitment of pwMS in clinical trials.MethodsWe implemented a battery consisting of the symbol digit modality test, 9-hole-peg-test, 25ft walking test and ABILHAND. pwMS were encouraged to sign up to the MS Register to record patient reported outcomes and ‘webEDSS’. Data from the MS Register and BartsMS Database were electronically linked.Results334 pwMS at different disease stages (EDSS 0–8.5) have been assessed at least annually. Of these, 64% had a relapsing and 36% a progressive disease course. Clinically meaningful data was obtained and displayed in an engaging portal for interpretation by the clinical team and pwMS.ConclusionIt’s feasible to implement multidimensional monitoring of pwMS to benefit (i) management of pwMS and (ii) trial recruitment, particularly for pwMS with EDSS >6.5. Longitudinal follow-up and data analysis is underway. Standardisation of a simple, regularly collected, dataset may improve performance assessment between centres.