Ublituximab. Good results as of last November

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frodo
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Ublituximab. Good results as of last November

Post by frodo » Tue Mar 12, 2019 5:40 am

Poster presented at the 26th Annual Meeting of the European Charcot Foundation, 15-17 November, 2018, Baveno, Italy

https://eu.eventscloud.com/file_uploads ... ubanks.pdf

Conclusions:

- Annualized Relapse Rate (ARR) of 0.07 was observed at Week 48, with 93% of subjects being relapse free.
- 74% of subjects fulfilled the criteria for NEDA.
- Median B cell depletion was >99% at the primary analysis point of Week 4 (n=48), and maintained at Week 24 and Week 48.
- No T1 Gd-enhancing lesions detected in any subjects at Week 24 or 48 (100% reduction; p=0.003).
- Subjects saw 10.6% reduction in total T2 lesion volume from baseline to Week 48 (p=0.002).
- Ublituximab was well tolerated and the most frequent AEs (all Grade 1 or 2) were Infusion Related Reactions (IRRs).
- No subjects discontinued due to an AE related to ublituximab.
- A rapid infusion time, as low as one hour, of 450mg, was well tolerated, produced high levels of B cell depletion and
- is now being studied in the Phase 3 ULTIMATE trials in MS.

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