Your browser doesn't support javascript.
loading
Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study.
Kira, Jun-Ichi; Nakahara, Jin; Sazonov, Denis V; Kurosawa, Takayoshi; Tsumiyama, Isao; Willi, Roman; Zalesak, Martin; Pingili, Ratnakar; Häring, Dieter A; Ramanathan, Krishnan; Kieseier, Bernd C; Merschhemke, Martin; Su, Wendy; Saida, Takahiko.
Afiliación
  • Kira JI; Translational Neuroscience Center, Graduate School of Medicine, Fukuoka Central Hospital, International University of Health and Welfare, Fukuoka, Japan/Department of Neurology, Brain and Nerve Center, Fukuoka Central Hospital, International University of Health and Welfare, Fukuoka, Japan.
  • Nakahara J; Department of Neurology, Keio University School of Medicine, Tokyo, Japan.
  • Sazonov DV; Siberian District Medical Centre, Federal Medical and Biological Agency of Russia, Novosibirsk, Russia.
  • Kurosawa T; Novartis Pharma KK, Tokyo, Japan.
  • Tsumiyama I; Novartis Pharma KK, Tokyo, Japan.
  • Willi R; Novartis Pharma AG, Basel, Switzerland.
  • Zalesak M; Novartis Pharma AG, Basel, Switzerland.
  • Pingili R; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Häring DA; Novartis Pharma AG, Basel, Switzerland.
  • Ramanathan K; Novartis Pharma AG, Basel, Switzerland.
  • Kieseier BC; Novartis Pharma AG, Basel, Switzerland/Department of Neurology, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany.
  • Merschhemke M; Novartis Pharma AG, Basel, Switzerland.
  • Su W; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Saida T; Kansai Multiple Sclerosis Center and Kyoto Min-iren Central Hospital, Kyoto, Japan.
Mult Scler ; 28(8): 1229-1238, 2022 07.
Article en En | MEDLINE | ID: mdl-34787005
BACKGROUND: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, has been developed as a treatment for relapsing multiple sclerosis (RMS) which can be self-administered at home. OBJECTIVE: To investigate the efficacy and safety of ofatumumab in RMS patients from Japan and Russia. METHODS: APOLITOS included a 24-week, double-blind, placebo-controlled core-part followed by an open-label extension-part. Patients were randomized (2:1) to subcutaneous ofatumumab 20 mg or placebo. Primary outcome was the number of gadolinium-enhancing (Gd+) T1 lesions per scan over 24 weeks. RESULTS: Sixty-four patients were randomized (ofatumumab, n = 43; placebo, n = 21). Primary endpoint was met; ofatumumab reduced Gd + T1 lesions versus placebo by 93.6% (p < 0.001) and the results were consistent across regions (Japan/Russia). Ofatumumab reduced annualized T2 lesion and relapse rate versus placebo by week 24. Both groups showed benefit from ofatumumab in the extension-part. Incidence of adverse events was lower with ofatumumab versus placebo (69.8% vs 81.0%); injection-related reactions were most common. No deaths, opportunistic infections, or malignancies were reported. CONCLUSION: Ofatumumab demonstrated superior efficacy versus placebo, with sustained effect through 48 weeks in RMS patients from Japan/Russia. Switching to ofatumumab after 24 weeks led to rapid radiological and clinical benefits. Safety findings were consistent with pivotal trials.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Mult Scler Asunto de la revista: NEUROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Mult Scler Asunto de la revista: NEUROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido