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

Annals of Neurology
Jerry S WolinskyLudwig Kappos

Abstract

No 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. The 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 ocrelizumab- (600 mg; n = 465) and placebo-treated (n = 234) patients. The 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 ...Continue Reading

References

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Citations

Aug 31, 2018·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·A N BoykoE I Gusev
Oct 2, 2019·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·L CrnošijaM Habek
Aug 20, 2020·Multiple Sclerosis : Clinical and Laboratory Research·Shreya NayakB Mark Keegan
Apr 16, 2019·Current Opinion in Neurology·Finja SchweitzerClemens Warnke
Apr 20, 2019·Nature Reviews. Neurology·Caila B VaughnBianca Weinstock-Guttman
Jun 12, 2020·Der Nervenarzt·Jonas GrafHans-Peter Hartung
Sep 10, 2019·Brain : a Journal of Neurology·Colm ElliottDouglas L Arnold
Sep 24, 2020·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Sophie MathaisUNKNOWN SFSEP and OFSEP investigators
Oct 23, 2020·Annals of Neurology·Giancarlo ComiUNKNOWN Expert Panel of the 27th Annual Meeting of the European Charcot Foundation
Mar 30, 2021·Neurología : publicación oficial de la Sociedad Española de Neurología·M Alonso-MorenoP Ciudad-Gutiérrez
Apr 8, 2021·Nature Communications·Arman EshaghiOlga Ciccarelli
Apr 24, 2021·Multiple Sclerosis : Clinical and Laboratory Research·Zoë Ygj van LieropCharlotte E Teunissen
Apr 27, 2021·Frontiers in Neurology·Virginia Meca-LallanaFrancisco Carlos Pérez-Miralles

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Clinical Trials Mentioned

NCT01194570

Software Mentioned

NEDA
ORATORIO
NEPAD

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