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Introduction <p>People with highly active multiple sclerosis benefit from early treatment with highly efficacious disease-modifying therapies. Here we present data on the efficacy of ublituximab versus teriflunomide in a subgroup of participants with highly active disease at baseline.</p> Methods <p>Pooled post hoc analyses of the phase&#xa0;3 ULTIMATE&#xa0;I (<i>N</i> = 549) and II (<i>N</i> = 545) studies evaluated efficacy measures at weeks&#xa0;12 and 96 in participants with highly active disease, defined as ≥ 2 relapses in the year prior and ≥ 1 gadolinium-enhancing (Gd+) T1 lesion at baseline.</p> Results <p>In the highly active disease population, the unadjusted annualized relapse rates (ARR) at week&#xa0;96 were 0.145 and 0.496 for the ublituximab (<i>n</i> = 88) and teriflunomide (<i>n</i> = 80) groups, respectively (70.8% relative reduction, <i>P</i> &lt; 0.001). The number (least squares means) of gadolinium-enhancing T1 lesions per scan for ublituximab versus teriflunomide was 0.114 versus 0.683 at week&#xa0;12 (83.3% relative reduction) and 0.038 versus 0.875 at week&#xa0;96 (95.6% relative reduction; both <i>P</i> &lt; 0.001). Corresponding values for new/enlarging T2 lesions (ublituximab versus teriflunomide) were 1.754 versus 4.127 at week&#xa0;12 (57.5% relative reduction) and 0.568 versus 6.367 at week&#xa0;96 (91.1% relative reduction, both <i>P</i> &lt; 0.001). No evidence of disease activity-3 (NEDA-3) rates with ublituximab versus teriflunomide were 29.5% versus 10.1% (<i>P</i> = 0.001) at week&#xa0;12 and 77.9% versus 16.4% (<i>P</i> &lt; 0.001) at week&#xa0;96 (weeks&#xa0;24–96, re-baselined).</p> Conclusion <p>Ublituximab was associated with significant treatment benefits across multiple efficacy measures versus teriflunomide in participants with highly active disease at baseline.</p> Trial Registration <p>Clinical trial registry: ULTIMATE&#xa0;I and II ClinicalTrials.gov numbers, NCT03277261 (registration date September 7, 2017) and NCT03277248 (registration date September 7, 2017).</p>

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Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月6日

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  • Hans-Peter Hartung,
  • Derrick Robertson,
  • Lawrence Steinman,
  • Douglas L. Arnold,
  • Peiqing Qian,
  • Sibyl Wray,
  • Edward Fox,
  • Christopher A. Garner,
  • Yihuan Xu,
  • Koby Mok,
  • Anne Gocke,
  • Bruce A. C. Cree,
  • Enrique Alvarez

摘要

Introduction

People with highly active multiple sclerosis benefit from early treatment with highly efficacious disease-modifying therapies. Here we present data on the efficacy of ublituximab versus teriflunomide in a subgroup of participants with highly active disease at baseline.

Methods

Pooled post hoc analyses of the phase 3 ULTIMATE I (N = 549) and II (N = 545) studies evaluated efficacy measures at weeks 12 and 96 in participants with highly active disease, defined as ≥ 2 relapses in the year prior and ≥ 1 gadolinium-enhancing (Gd+) T1 lesion at baseline.

Results

In the highly active disease population, the unadjusted annualized relapse rates (ARR) at week 96 were 0.145 and 0.496 for the ublituximab (n = 88) and teriflunomide (n = 80) groups, respectively (70.8% relative reduction, P < 0.001). The number (least squares means) of gadolinium-enhancing T1 lesions per scan for ublituximab versus teriflunomide was 0.114 versus 0.683 at week 12 (83.3% relative reduction) and 0.038 versus 0.875 at week 96 (95.6% relative reduction; both P < 0.001). Corresponding values for new/enlarging T2 lesions (ublituximab versus teriflunomide) were 1.754 versus 4.127 at week 12 (57.5% relative reduction) and 0.568 versus 6.367 at week 96 (91.1% relative reduction, both P < 0.001). No evidence of disease activity-3 (NEDA-3) rates with ublituximab versus teriflunomide were 29.5% versus 10.1% (P = 0.001) at week 12 and 77.9% versus 16.4% (P < 0.001) at week 96 (weeks 24–96, re-baselined).

Conclusion

Ublituximab was associated with significant treatment benefits across multiple efficacy measures versus teriflunomide in participants with highly active disease at baseline.

Trial Registration

Clinical trial registry: ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 (registration date September 7, 2017) and NCT03277248 (registration date September 7, 2017).