ECTRIMS eLearning

High-dose biotin in progressive multiple sclerosis : a prospective study of 86 patients in routine clinical practice
Author(s): ,
L. Couloume
Affiliations:
Service de Neurologie, CHU de Nantes, Nantes
,
S. Ory
Affiliations:
Service de Neurologie, CHU de Nantes, Nantes
,
S. Wiertlewski
Affiliations:
Service de Neurologie, CHU de Nantes, Nantes
,
D.-A. Laplaud
Affiliations:
Service de Neurologie, CHU de Nantes, Nantes
L. Michel
Affiliations:
Service de Neurologie, CHU de Rennes, Rennes, France
ECTRIMS Learn. Couloume L. 10/10/18; 229554; EP1717
Laura Couloume
Laura Couloume
Contributions
Abstract

Abstract: EP1717

Type: Poster Sessions

Abstract Category: Therapy - Others

Introduction: Biotin is a cofactor for four essential carboxylases, and may thus support myelin repair and protect against axonal degeneration. A recent controlled trial has established that high-dose biotin supplementation has a stabilizing effect on progression of multiple sclerosis (MS).
Objectives: To analyze the impact of high-dose biotin in routine clinical practice on disability progression, annualized relapse rate, quality of life and tolerance in progressive MS patients.
Methods: Progressive MS patients who started high-dose biotin in Nantes hospital from june 29, 2016 to march 14, 2017 were included. Patients were examined at the start of biotin, 6 months and 12 months after the beginning of the treatment. Expanded Disability Status Scale (EDSS), relapses, walking test (T25W), symbol digit modalities test (SDMT), clinical global impression (CGI) scale, safety and quality of life were collected.
Results: We included 86 Progressive MS patients. Forty-two patients had primary progressive MS and forty-four had secondary progressive MS. At baseline, patients were 52,74±0,96 yrs-old. Mean EDSS score was 5,91±0,13 and mean disease duration was 15,02±0,90 yrs.
Thirteen patients stopped biotin before 12 months.
At 12 months, EDSS score was 6,02±1,18 (vs 5,91±1,17 at baseline, p=0,58). We observed a significant increase of the T25W at 12 months (29,16±4,38 at 12 months vs 25,68±3,24, p < 0,01, paired t test).
Twelve patients (13,9%) presented an improvement of their disability (defined as a decrease of >=0,5 point or >=1 point in EDSS (if baseline score was 6-7 or 4,5-5,5, respectively) or a >=20% decrease in T25W time). Six of them had concomitant disease-modifying drug therapy (DMD).
Annualized relapse rate was 0,07±0,03 in the previous year and 0,04±0,02 at one year (NS). There were no significant differences for SDMT and EQ5D. Only the subscore of EQ5D about pain and discomfort improved significantly (1,89±0,06 vs 2,10±0,05, p < 0,01, paired t test). 45,2% of patients reported CGI= 4, 31,5% CGI< 4, 23,3% CGI>4 at 12 months. Fourteen patients reported adverse events
Conclusions: In this real-life study, 13,9% of patients improved their disability (compared to 12,3% in the controlled study). However, half of these patients had a concomitant DMD. No significant improvement of the EDSS score and T25W were observed after one year of treatment. A Phase III study is actually warranted to conclude on the efficacy of high-dose biotin.
Disclosure: L.Couloume: nothing to disclose. S.Ory : nothing to disclose. Dr Sandrine Wiertlewski received consultancy fees, speaker fees, honoraria and clinical research grants (non-personal) from Biogen-Idec, Genzyme, Novartis, Merck, Roche, Sanofi-Aventis and Teva. Pr David-Axel Laplaud : honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday, research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medda. Dr Laure Michel received honoraria as a consultant from Biogen, Teva, Novartis, Roche, Merck and sanofi genzyme.

Abstract: EP1717

Type: Poster Sessions

Abstract Category: Therapy - Others

Introduction: Biotin is a cofactor for four essential carboxylases, and may thus support myelin repair and protect against axonal degeneration. A recent controlled trial has established that high-dose biotin supplementation has a stabilizing effect on progression of multiple sclerosis (MS).
Objectives: To analyze the impact of high-dose biotin in routine clinical practice on disability progression, annualized relapse rate, quality of life and tolerance in progressive MS patients.
Methods: Progressive MS patients who started high-dose biotin in Nantes hospital from june 29, 2016 to march 14, 2017 were included. Patients were examined at the start of biotin, 6 months and 12 months after the beginning of the treatment. Expanded Disability Status Scale (EDSS), relapses, walking test (T25W), symbol digit modalities test (SDMT), clinical global impression (CGI) scale, safety and quality of life were collected.
Results: We included 86 Progressive MS patients. Forty-two patients had primary progressive MS and forty-four had secondary progressive MS. At baseline, patients were 52,74±0,96 yrs-old. Mean EDSS score was 5,91±0,13 and mean disease duration was 15,02±0,90 yrs.
Thirteen patients stopped biotin before 12 months.
At 12 months, EDSS score was 6,02±1,18 (vs 5,91±1,17 at baseline, p=0,58). We observed a significant increase of the T25W at 12 months (29,16±4,38 at 12 months vs 25,68±3,24, p < 0,01, paired t test).
Twelve patients (13,9%) presented an improvement of their disability (defined as a decrease of >=0,5 point or >=1 point in EDSS (if baseline score was 6-7 or 4,5-5,5, respectively) or a >=20% decrease in T25W time). Six of them had concomitant disease-modifying drug therapy (DMD).
Annualized relapse rate was 0,07±0,03 in the previous year and 0,04±0,02 at one year (NS). There were no significant differences for SDMT and EQ5D. Only the subscore of EQ5D about pain and discomfort improved significantly (1,89±0,06 vs 2,10±0,05, p < 0,01, paired t test). 45,2% of patients reported CGI= 4, 31,5% CGI< 4, 23,3% CGI>4 at 12 months. Fourteen patients reported adverse events
Conclusions: In this real-life study, 13,9% of patients improved their disability (compared to 12,3% in the controlled study). However, half of these patients had a concomitant DMD. No significant improvement of the EDSS score and T25W were observed after one year of treatment. A Phase III study is actually warranted to conclude on the efficacy of high-dose biotin.
Disclosure: L.Couloume: nothing to disclose. S.Ory : nothing to disclose. Dr Sandrine Wiertlewski received consultancy fees, speaker fees, honoraria and clinical research grants (non-personal) from Biogen-Idec, Genzyme, Novartis, Merck, Roche, Sanofi-Aventis and Teva. Pr David-Axel Laplaud : honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday, research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medda. Dr Laure Michel received honoraria as a consultant from Biogen, Teva, Novartis, Roche, Merck and sanofi genzyme.

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