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

Jun Ichi Kira, Jin Nakahara, Denis V. Sazonov, Takayoshi Kurosawa, Isao Tsumiyama, Roman Willi, Martin Zalesak, Ratnakar Pingili, Dieter A. Häring, Krishnan Ramanathan, Bernd C. Kieseier, Martin Merschhemke, Wendy Su, Takahiko Saida

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)1229-1238
Number of pages10
JournalMultiple Sclerosis Journal
Issue number8
Publication statusPublished - 2022 Jul


  • Japan
  • MRI
  • Ofatumumab
  • clinical trial
  • efficacy
  • relapsing MS
  • safety

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology


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