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2020 —
Background: Ublituximab, a novel monoclonal antibody (mAb)
targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced
B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC).
Greater ADCC may allow lower doses and shorter infusion times versus other
anti-CD20 mAbs.
targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced
B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC).
Greater ADCC may allow lower doses and shorter infusion times versus other
anti-CD20 mAbs.
Objective: The objective was to determine optimal dose,
infusion time, and activity of ublituximab in relapsing multiple sclerosis.
infusion time, and activity of ublituximab in relapsing multiple sclerosis.
Methods: This is a phase 2, placebo-controlled study.
Patients received three ublituximab infusions (150 mg over 1-4 hours on day 1
and 450-600 mg over 1-3 hours on day 15 and week 24) in six dosing cohorts. The
primary endpoint was B-cell depletion.
Patients received three ublituximab infusions (150 mg over 1-4 hours on day 1
and 450-600 mg over 1-3 hours on day 15 and week 24) in six dosing cohorts. The
primary endpoint was B-cell depletion.
Results: In all cohorts (N =
48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and
48. Most common adverse events (AEs) were infusion-related reactions (all grade
1-2), with no apparent increased incidence at shorter infusion times. There
were no AE-related discontinuations. At weeks 24 and 48, no T1
gadolinium-enhancing lesions (p = 0.003) and a
10.6% decrease in T2 lesion volume (p = 0.002)
were detected. The annualized relapse rate was 0.07; 93% remained relapse free
on study. Overall, 74% of patients had no evidence of disease activity (NEDA).
48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and
48. Most common adverse events (AEs) were infusion-related reactions (all grade
1-2), with no apparent increased incidence at shorter infusion times. There
were no AE-related discontinuations. At weeks 24 and 48, no T1
gadolinium-enhancing lesions (p = 0.003) and a
10.6% decrease in T2 lesion volume (p = 0.002)
were detected. The annualized relapse rate was 0.07; 93% remained relapse free
on study. Overall, 74% of patients had no evidence of disease activity (NEDA).
Conclusion: Ublituximab was safely infused as rapid as 1 hour,
producing robust B-cell depletion and profound reductions in magnetic resonance
imaging (MRI) activity and relapses.
producing robust B-cell depletion and profound reductions in magnetic resonance
imaging (MRI) activity and relapses.
Keywords: TG-1101; Ublituximab; gadolinium-enhancing lesions;
magnetic resonance imaging; multiple sclerosis; relapse.
magnetic resonance imaging; multiple sclerosis; relapse.
Source: https://pubmed.ncbi.nlm.nih.gov/32351164/
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