Bruce Cree, MD, PhD, MAS, FAAN, shared his thoughts on the data from the ULTIMATE I and II studies of ublituximab's effect on measures of MS disability, including EDSS and 9HPT scores.
Disclaimer: The American Academy of Neurology requested that all attendees remain masked during the Annual Meeting. This interviewee voluntarily removed their mask for this interview.
Bruce Cree, MD, PhD, MAS, FAAN: In the ublituximab ULTIMATE I and II clinical trials, we looked at MS-related disability in several ways. One was looking at confirmed disability progression, where there wasn't a difference between ublituximab and teriflunomide. But another way to look at disability is by asking a question: who improved? Confirmed disability improvement is the converse of confirmed disability progression, and in the study that's presented at this meeting, we showed that ublituximab had a robust effect in terms of confirmed disability improvement, as measured by the Expanded Disability Status Scale, compared to teriflunomide. And this is true not only for confirmed disability improvement at 12 weeks but as a measure that was sustained all the way through to the end of the study. So individuals could have improved, shown a confirmed improvement to 12 weeks, and then we asked the question: Of those individuals who improved at 12 weeks, how many of those sustain that improvement in disability to the end of the trial? There, there was clearly a difference favoring ublituximab over teriflunomide.
We also ask the question in terms of the degree of improvement, 1 point, 1.5 points, or 2 points, in terms of EDSS improvement. And for all of these outcomes, for the 1- and 1.5-point improvements, there is a statistically significant effect after week 48, favoring ublituximab over teriflunomide. In addition to looking at the EDSS, which everybody has looked at, we also looked at the 9-hole peg test and timed 25-foot walk. Nine-hole peg test also showed favorable results, reaching statistical significance at multiple time points, for a 20% improvement in the speed of the 9-hole peg test. Another way to look at that would be that a 5-second improvement in the 9-hole peg test is considered to be clinically meaningful improvement. So, we looked at that too, and that also showed an improvement for the dominant hand, and similar results applied for the nondominant hand.
Now, the results for the timed 25-foot walk were a little bit disappointing. We did not see an improvement for timed 25-foot walk at the end of week 96. Timed 25-foot walk was very similar between teriflunomide and ublituximab. And I think part of the reason for that is that about half the individuals coming into this study had a normal timed 25-foot walk, so it was very difficult to show improvement over normal, at least for half of the individuals coming into the trial.
Transcript edited for clarity.