Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis - Report - MDSpire
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Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis
Clinical Report: Outcomes of Ublituximab in Treatment-Naïve Patients
Overview
Ublituximab demonstrated superior efficacy compared to teriflunomide in treatment-naïve patients with relapsing multiple sclerosis, showing lower annualized relapse rates and improved disability outcomes.
Background
The early initiation of high-efficacy disease-modifying therapies (DMTs) is critical in managing relapsing multiple sclerosis (RMS) to reduce disability progression and relapse rates. Ublituximab, a novel anti-CD20 monoclonal antibody, offers a promising option for treatment-naïve patients.
Data Highlights
Outcome
Ublituximab
Teriflunomide
p-value
Annualized Relapse Rate (ARR)
0.081 (n=345)
0.188 (n=377)
<0.001
12-week Confirmed Disability Improvement
10.7%
5.3%
0.010
Gd+ T1 Lesions
0.031
0.791
<0.001
New/Enlarging T2 Lesions
0.390
4.144
<0.001
Key Findings
Ublituximab resulted in a significantly lower annualized relapse rate compared to teriflunomide in treatment-naïve patients (0.081 vs. 0.188, p < 0.001).
In the early treatment subpopulation, ublituximab also showed a lower annualized relapse rate (0.130 vs. 0.334, p = 0.004).
The rate of 12-week confirmed disability improvement was higher with ublituximab than teriflunomide (10.7% vs. 5.3%, p = 0.010).
Ublituximab significantly reduced gadolinium-enhancing T1 lesions compared to teriflunomide (0.031 vs. 0.791, p < 0.001).
New/enlarging T2 lesions were also significantly lower in the ublituximab group (0.390 vs. 4.144, p < 0.001).
Clinical Implications
The findings indicate that ublituximab may be a more effective treatment option for patients with relapsing multiple sclerosis who are treatment-naïve. Early initiation of high-efficacy DMTs like ublituximab could lead to better long-term outcomes in this patient population.
Conclusion
Ublituximab shows significant efficacy in treatment-naïve patients with relapsing multiple sclerosis.
by Derrick Robertson, Enrique Alvarez, Lawrence Steinman, Hans-Peter Hartung, Peiqing Qian, Krzysztof Selmaj, Sibyl Wray, Daniel Wynn, Edward J. Fox, Koby Mok, Hari P. Miskin, Yihuan Xu, Christopher A. Garner, Bruce A. C. Cree