Laura Couloume1, Laetitia Barbin2, Emmanuelle Leray3, Sandrine Wiertlewski4, Emmanuelle Le Page5, Anne Kerbrat5, Solenn Ory5, Damien Le Port5, Gilles Edan5, David-Axel Laplaud6, Laure Michel7. 1. Service de Neurologie, CHU Nantes, Nantes, France. 2. CIC0004 Inserm, Nantes, France. 3. Univ Rennes, EHESP, REPERES (Pharmacoepidemiology and health services research)-EA 7449, Rennes, France. 4. Service de Neurologie, CHU Nantes, Nantes, France/CIC0004 Inserm, Nantes, France. 5. Univ Rennes, CHU Rennes, Neurology, Centre d'Investigation Clinique de Rennes (CIC Inserm 1414), Rennes, France. 6. Service de Neurologie, CHU Nantes, Nantes, France/CIC0004 Inserm, Nantes, France/Centre de Recherche en Transplantation et Immunologie (CRTI), Inserm U1064, Nantes, France/Université de Nantes, Nantes, France. 7. Service de Neurologie, CHU Pontchaillou, Rennes, France; Univ Rennes, CHU Rennes, Neurology, Centre d'Investigation Clinique de Rennes (CIC Inserm 1414), Rennes, France; Unité Mixte de Recherche (UMR) S1236, INSERM, University of Rennes, Etablissement Français du Sang, Rennes, France/Suivi Immunologique des Thérapeutiques Innovantes, Centre Hospitalier Universitaire de Rennes, Etablissement Français du Sang, Rennes, France.
Abstract
BACKGROUND: A recent controlled trial suggested that high-dose biotin supplementation reverses disability progression in patients with progressive multiple sclerosis. OBJECTIVE: To analyze the impact of high-dose biotin in routine clinical practice on disability progression at 12 months. METHODS: Progressive multiple sclerosis patients who started high-dose biotin at Nantes or Rennes Hospital between 3 June 2015 and 15 September 2017 were included in this prospective study. Disability outcome measures, patient-reported outcome measures, relapses, magnetic resonance imaging (MRI) data, and adverse events were collected at baseline, 6, and 12 months. RESULTS: A total of 178 patients were included. At baseline, patients were 52.0 ± 9.4 years old, mean Expanded Disability Status Scale (EDSS) score was 6.1 ± 1.3, mean disease duration was 16.9 ± 9.5 years. At 12 months, 3.8% of the patients had an improved EDSS score. Regarding the other disability scales, scores either remained stable or increased significantly. In total, 47.4% of the patients described stability, 27.6% felt an improvement, and 25% described a worsening. Four patients (2.2%) had a relapse. Of the 74 patients (41.6%) who underwent an MRI, 20 (27.0%) had new T2 lesions, 8 (10.8%) had gadolinium-enhancing lesions. Twenty-five (14%) reported adverse event. CONCLUSION: In this study, high-dose biotin did not seem to be associated with a clear improvement in disability.
BACKGROUND: A recent controlled trial suggested that high-dose biotin supplementation reverses disability progression in patients with progressive multiple sclerosis. OBJECTIVE: To analyze the impact of high-dose biotin in routine clinical practice on disability progression at 12 months. METHODS: Progressive multiple sclerosis patients who started high-dose biotin at Nantes or Rennes Hospital between 3 June 2015 and 15 September 2017 were included in this prospective study. Disability outcome measures, patient-reported outcome measures, relapses, magnetic resonance imaging (MRI) data, and adverse events were collected at baseline, 6, and 12 months. RESULTS: A total of 178 patients were included. At baseline, patients were 52.0 ± 9.4 years old, mean Expanded Disability Status Scale (EDSS) score was 6.1 ± 1.3, mean disease duration was 16.9 ± 9.5 years. At 12 months, 3.8% of the patients had an improved EDSS score. Regarding the other disability scales, scores either remained stable or increased significantly. In total, 47.4% of the patients described stability, 27.6% felt an improvement, and 25% described a worsening. Four patients (2.2%) had a relapse. Of the 74 patients (41.6%) who underwent an MRI, 20 (27.0%) had new T2 lesions, 8 (10.8%) had gadolinium-enhancing lesions. Twenty-five (14%) reported adverse event. CONCLUSION: In this study, high-dose biotin did not seem to be associated with a clear improvement in disability.