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Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study.

Authors :
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
Source :
Multiple Sclerosis Journal; Jul2022, Vol. 28 Issue 8, p1229-1238, 10p
Publication Year :
2022

Abstract

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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
13524585
Volume :
28
Issue :
8
Database :
Complementary Index
Journal :
Multiple Sclerosis Journal
Publication Type :
Academic Journal
Accession number :
157382409
Full Text :
https://doi.org/10.1177/13524585211055934