Title :

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

Author(s) :

Wolinsky Jerry, S [Auteur]
Montalban, Xavier [Auteur]
Hauser Stephen, L [Auteur]
Giovannoni, Gavin [Auteur]
Vermersch, Patrick [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Bernasconi, Corrado [Auteur]
Deol-Bhullar, Gurpreet [Auteur]
Garren, Hideki [Auteur]
Chin, Peter [Auteur]
Belachew, Shibeshih [Auteur]
Kappos, Ludwig [Auteur]

Journal title :

Annals of neurology

Abbreviated title :

Ann. Neurol.

Publication date :

2018-08-29

ISSN :

1531-8249

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

OBJECTIVE: 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). ...
Show more >OBJECTIVE: 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. METHODS: 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. RESULTS: 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 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 both measures were consistent with the compound outcomes. INTERPRETATION: Compared to placebo, ocrelizumab enhanced 3-fold the proportion of PPMS patients with no evidence of either progression or inflammatory disease activity. NEPAD may represent a sensitive and meaningful comprehensive measure of disease control in patients with PPMS. Ann Neurol 2018;84:527-536.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Inserm
Université de Lille
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Research team(s) :

Immunity, inflammation and fibrsis in auto and allo-reactivity

Submission date :

2019-03-01T14:08:00Z