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Introduction <p>Ofatumumab demonstrated superior efficacy and similar safety versus teriflunomide in ASCLEPIOS I/II in people with relapsing multiple sclerosis; no new safety concerns and sustained efficacy were observed up to 4 years in the open-label extension study ALITHIOS. Here, we further characterise the safety and efficacy of ofatumumab up to 5&#xa0;years by discussing infection outcomes in the COVID-19 era and providing a comprehensive overview of participant disability outcomes.</p> Methods <p>Safety (<i>N</i> = 1969; participants who received ≥ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS) and efficacy sets (<i>N</i> = 1882; participants randomised to ofatumumab [OMB-OMB] or teriflunomide [TER-OMB] in ASCLEPIOS I/II, regardless of whether they entered ALITHIOS) were analysed. Data cutoff: 25 September 2022.</p> Results <p>The exposure-adjusted incidence rates (per 100 patient-years) of adverse events (AEs, 124.65), serious AEs (4.68), serious infections (1.63), and malignancies (0.32) remained consistent with previous findings up to 5&#xa0;years of follow-up, with no new safety signals identified. With ofatumumab treatment up to 5&#xa0;years, &gt; 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse rates (ARR) remained low, and magnetic resonance imaging (MRI) activity was almost completely suppressed with OMB-OMB through years 1–5; after switching from teriflunomide (years 2–3), pronounced reductions in ARR/MRI activity were observed with low rates sustained through years 3–5. During year 5, 9 of 10 participants in both groups were free of disease activity (NEDA-3).</p> Conclusion <p>Ofatumumab has a favourable benefit-risk profile that is sustained up to 5&#xa0;years.</p> <p><b>Trial registration</b>: ALITHIOS (NCT03650114): <a href="https://clinicaltrials.gov/ct2/show/NCT03650114">https://clinicaltrials.gov/ct2/show/NCT03650114</a></p>

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Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月13日

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  • Stephen L. Hauser,
  • Jeffrey A. Cohen,
  • Jérôme de Sèze,
  • Sven G. Meuth,
  • Paul S. Giacomini,
  • Jin Nakahara,
  • Celia Oreja-Guevara,
  • Derrick Robertson,
  • Sibyl Wray,
  • Alit Bhatt,
  • Xixi Hu,
  • Jing Xi,
  • Rebecca Piccolo,
  • Valentine Jehl,
  • Roseanne Sullivan,
  • Ibolya Boer,
  • Heinz Wiendl,
  • Ludwig Kappos

摘要

Introduction

Ofatumumab demonstrated superior efficacy and similar safety versus teriflunomide in ASCLEPIOS I/II in people with relapsing multiple sclerosis; no new safety concerns and sustained efficacy were observed up to 4 years in the open-label extension study ALITHIOS. Here, we further characterise the safety and efficacy of ofatumumab up to 5 years by discussing infection outcomes in the COVID-19 era and providing a comprehensive overview of participant disability outcomes.

Methods

Safety (N = 1969; participants who received ≥ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS) and efficacy sets (N = 1882; participants randomised to ofatumumab [OMB-OMB] or teriflunomide [TER-OMB] in ASCLEPIOS I/II, regardless of whether they entered ALITHIOS) were analysed. Data cutoff: 25 September 2022.

Results

The exposure-adjusted incidence rates (per 100 patient-years) of adverse events (AEs, 124.65), serious AEs (4.68), serious infections (1.63), and malignancies (0.32) remained consistent with previous findings up to 5 years of follow-up, with no new safety signals identified. With ofatumumab treatment up to 5 years, > 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse rates (ARR) remained low, and magnetic resonance imaging (MRI) activity was almost completely suppressed with OMB-OMB through years 1–5; after switching from teriflunomide (years 2–3), pronounced reductions in ARR/MRI activity were observed with low rates sustained through years 3–5. During year 5, 9 of 10 participants in both groups were free of disease activity (NEDA-3).

Conclusion

Ofatumumab has a favourable benefit-risk profile that is sustained up to 5 years.

Trial registration: ALITHIOS (NCT03650114): https://clinicaltrials.gov/ct2/show/NCT03650114