Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis
Turner, Benjamin (The Royal London Hospital)
Cree, Bruce A. C (University of California)
Kappos, Ludwig (University Hospital Basel (Basilea, Suïssa))
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Papeix, Caroline (Pitié-Salpêtrière Hospital)
Wolinsky, Jerry S. (The University of Texas Health Science Center at Houston (UTHealth))
Buffels, Regine (F. Hoffmann-La Roche Ltd)
Fiore, Damian (Genentech. Inc)
Garren, Hideki (Genentech. Inc)
Han, Jian (Genentech. Inc)
Hauser, Stephen L. (University of California)
Universitat Autònoma de Barcelona. Departament de Medicina

Fecha:	2019
Resumen:	Objective: The efficacy and safety of ocrelizumab, versus interferon (IFN) β-1a, for the treatment of relapsing multiple sclerosis (RMS) from the identically designed OPERA I (NCT01247324) and OPERA II (NCT01412333) phase III studies has been reported; here we present subgroup analyses of efficacy endpoints from the pooled OPERA I and OPERA II populations. Methods: Patients with RMS were randomized to either ocrelizumab 600 mg administered by intravenous infusion every 24 weeks or subcutaneous IFN β-1a 44 µg three times per week throughout the 96-week treatment period. Relapse, disability, and MRI outcomes were analyzed for predefined and post hoc subgroups based on demographic and disease characteristics along with prior treatment using appropriate statistical tests to determine the treatment effect in subgroups and treatment-by-subgroup interactions. Results: The significant treatment benefit of ocrelizumab, versus IFN β-1a, observed in the overall OPERA I and OPERA II pooled populations was maintained across most subgroup strata for all endpoints, including annualized relapse rate, disability progression, and MRI outputs. Conclusions: The treatment effect of ocrelizumab versus IFN β-1a, measured by clinical and MRI outcomes, was maintained across most of the subgroups and strata of interest, and the pattern of treatment benefit across all subgroups was consistent with that from the pooled OPERA studies.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Relapsing ; Multiple sclerosis ; Ocrelizumab ; Subgroup ; Interferon β-1a ; Phase 3
Publicado en:	Journal of Neurology, Vol. 266 Núm. 5 (may 2019) , p. 1182-1193, ISSN 1432-1459

DOI: 10.1007/s00415-019-09248-6
PMID: 30820738

12 p, 888.5 KB

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