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Effect of MD1003 (High-Dose Biotin) in Spinal Progressive Multiple Sclerosis (MS-SPI): Subgroup Analyses
ECTRIMS Online Library. Tourbah A. Oct 26, 2017; 200442
Ayman Tourbah
Ayman Tourbah
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Abstract
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Abstract: P787

Type: Poster

Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS

Objectives: MS-SPI was a 12-month (M) double-blind, randomised, placebo-controlled study evaluating the effect of MD1003 on non-active progressive multiple sclerosis (PMS) patients (n=154), followed by an open-label extension phase where all patients received MD1003. The results indicated at 9 months a statistically significant 3 month confirmed improvement of patients in the MD1003 as compared to placebo, using the Expanded Disability Status Scale (EDSS) score. Here we present the results of subgroup analyses in the main phase of the study.
Methods: The global population (n=154) was split into the following subgroups of interest: EDSS low (4.5-5.5; n=35) or high (6-7; n=119); concomitant use of fampridine (n=72) or not (n=82); primary progressive MS (PPMS; n=55) or secondary progressive MS (SPMS; n=99); concomitant use of disease-modifying therapy (DMT; n=61) or not (n=93); and undergoing new intensive physical therapy during the study (n=29) or not (n=125). Analyses of both observed and imputed data were performed on these covariates using van Elteren tests and mixed models. A forest plot analysis of the treatment's effect in different subgroups using a mixed model has been performed.
Results: When adjusting for different baseline covariates, MD1003 effect is statistically significant for the whole population. The P-values for the change in EDSS from baseline to M12 in the intention-to-treat population (observed data, imputed data) were: EDSS score: 0.0181, 0.0604; fampridine use: 0.0083, 0.0304; PMS type: 0.0056, 0.0407; DMT use: 0.0098, 0.0407; undergoing physical therapy: 0.0092, 0.0390; mixed model analysis of EDSS score/fampridine use/PMS type/DMT use: 0.0866, 0.0733; and mixed model analysis of MS type/DMT/physical therapy: 0.0438, 0.0345.
The forest plot analysis showed that whatever the subgroup studied the results systematically favoured the MD1003 over the placebo group. Although the relatively small numbers of patients in some of the subgroups precluded statistical significance, the same trends were observed among all different subgroups.
Discussion: There is no evidence that a specific subgroup did not benefit from MD1003 treatment in patients included in the MS-SPI trial.
Disclosure:
David-Axel Laplaud received honoraria from Biogen, Novartis, Merck, Sanofi-Genzyme, Roche and grants from Sanofi-Genzyme, Medday and Novartis.
Olivier Gout has received, in the last year, lecturing fees and/or travel grants from Biogen Idec, Medday and Sanofi-Genzyme.
Pierre Clavelou has received honoraria and consulting fees from Almirall, Medday, Merck, Novartis, Roche, Sanofi-Genzyme and Teva, and research support from Biogen, Merck and Novartis.
Jean Pelletier received consulting fees and travel grants from Biogen, Sanofi-Genzyme, Novartis, Teva, Merck-Serono, Roche, and Medday, and unconditional research grants from Biogen, Novartis, Roche and Merck-Serono.
Frederic Sedel is an employee of Medday.
Ayman Tourbah has received, in the last year, consulting and lecturing fees, travel grants and research support from Biogen Idec, Novartis, Medday, Merck Serono, Hoffman La Roche, Sanofi-Genzyme and Teva.

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