Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial

ObjectiveNo evidence of progression or active disease (NEPAD) is a novel combined endpoint defined by the absence of both progression and inflammatory disease activity in primary progressive multiple sclerosis (PPMS). In the placebo ‐controlled phase III ORATORIO study (NCT01194570), we investigated the effect of ocrelizumab on this comprehensive outcome and its components in a post‐hoc analysis.MethodsThe proportion of patients with NEPAD (no evidence of progression [NEP; no 12 ‐week confirmed progression of ≥1/≥0.5 points on the Expanded Disability Status Scale if the baseline score was ≤5.5/>5.5 points, respectively; no 12 ‐week confirmed progression of ≥20% on the Timed 25‐Foot Walk test and 9‐Hole Peg Test], no brain magnetic resonance imaging activity [no new/enlarging T2 lesions and no T1 gadolinium‐enhancing lesions], and no protocol‐defined relapse) from baseline to week 120 was determined in ocreliz umab‐ (600 mg; n = 465) and placebo‐treated (n = 234) patients.ResultsThe majority of ORATORIO study patients with PPMS experienced clinical progression or evidence of disease activity. From baseline to week 120, 29.9% and 42.7% ocrelizumab ‐treated compared to 9.4% and 29.1% placebo‐treated patients maintained NEPAD (relative risk [95% confidence interval {CI}], 3.15 [2.07–4.79];p <  0.001) and NEP (relative risk [95% CI], 1.47 [1.17–1.84];p <  0.001), respectively. Effects on the individual components of bo...
Source: Annals of Neurology - Category: Neurology Authors: Tags: Research Article Source Type: research