Abstract Details

Title Effect of MD1003 (high dose Pharmaceutical grade Biotin) in the Treatment of Progressive MS: Earlier Treatment Results in Lower Disability Over 48 Months

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-063

Objective To evaluate the effects of MD1003 during the open-label extension phase of the MS-SPI study.

Background MS-SPI was a 12-month (M) double-blind study of MD1003 (n=103) vs placebo (n=51) in patients (pts) with nonactive progressive multiple sclerosis (PMS). As reported previously, expanded disability status scale (EDSS) and/or timed 25-foot walk improvement, mean EDSS (mEDSS) score, and clinical/subject global impression (CGI/SGI) score were all significantly (P<0.05) in favor of MD1003 vs placebo (Tourbah et al., 2016). In the open-label extension phase, all pts received MD1003. Here, we present data at 48M of follow-up (shown as MD1003>MD1003 [MM] vs placebo>MD1003 [PM]).

Design/Methods A total of 133 pts (MM: 91; PM: 42) entered the extension phase. We assessed time to first decreased/increased EDSS (Kaplan-Meier), mEDSS change from baseline, and CGI/SGI.

Results In time to first decreased/increased EDSS analyses up to 12M, the results favored MD1003 over placebo (hazard ratio [HR], 3.55 and 0.42, respectively), though they were not significant (P>0.05) in this relatively small study. In similar analyses up to 48M, the probability of improvement/worsening again favored MD1003 over placebo (HR, 2.47, P>0.05 and 0.80, P>0.05, respectively). Throughout the extension phase, the mean change in EDSS score was numerically lower in the MM group (vs PM group); the difference in mEDSS score between the MM and PM groups was significant at M18 (P<0.05) and M30 (P<0.05) but not at other timepoints. In the extension phase, CGI and SGI scores remained stable for MM pts and improved for PM pts upon switching to MD1003.

Conclusions Results from the MS-SPI study at 4 years of follow-up indicate that 1) delayed MD1003 treatment results in higher disability over time, 2) pts show improvement when switching from placebo to MD1003, and 3) the effects of MD1003 observed in the double-blind phase are sustained over time.

Authors/Disclosures
Jerome De Seze PRESENTER	Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma.
Gilles Edan	Gilles Edan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Gilles Edan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Gilles Edan has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Biogen. Gilles Edan has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck.
Thibault Moreau	Thibault Moreau has nothing to disclose.
Bruno Brochet, MD, FEAN (University of Bordeaux)	Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for celgene. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for jansen. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biogen. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for novartis. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for biogen. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for celgene.
Frederic Sedel	No disclosure on file
Ayman P. Tourbah (Department of Neurology University Hospital Raymond Poincaré)	No disclosure on file

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