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Relapses in Patients Treated with High-Dose Biotin for Progressive Multiple Sclerosis

Sophie Mathais 1 Xavier Moisset 2, 1, * Bruno Pereira 1 Frederic Taithe 1 Jonathan Ciron 3 Pierre Labauge 4, 5 Cécile Dulau 6, 7 David Laplaud 8, 9, 10 Jérôme de Sèze 11, 12 Jean Pelletier 13 Eric Berger 14 Christine Lebrun-Frenay 15, 16 Giovanni Castelnovo 17 Gilles Edan 18, 19 Gilles Defer 20 Patrick Vermersch 21, 22 B Bourre 23 J.-P. Camdessanché 24 Laurent Magy 25 A.-M. Guennoc 26 Guillaume Mathey 27, 28 Thibault Moreau 29 Olivier Gout 30 O Heinzlef 31 Elisabeth Maillart 32 Sandra Vukusic 33, 34, 35 Pierre Clavelou 2, 1
* Corresponding author
1 CHU Clermont-Ferrand
2 Neuro-Dol - Neuro-Dol - Clermont Auvergne
3 Département de Neurologie [Toulouse]
4 CHU Montpellier
5 UM - Université de Montpellier
6 INSERM, Neurocentre Magendie, U1215, Physiopathologie de la Plasticité Neuronale, F-33000 Bordeaux, France;
7 CIC Bordeaux
8 CHU Nantes - Centre hospitalier universitaire de Nantes
9 CIC - Nantes
10 U1064 Inserm - CRTI - Centre de Recherche en Transplantation et Immunologie
11 Centre d’Investigation Clinique Plurithématique (CIC - P) - CIC Strasbourg
12 Service de Neurologie [Strasbourg]
13 APHM - Assistance Publique - Hôpitaux de Marseille
14 Service de neurologie [Besançon]
15 CHU - Hôpital Pasteur [Nice]
16 CHU Nice - Centre Hospitalier Universitaire de Nice
17 Pôle NIRR - Service de Neurologie [CHU Nimes]
18 CIC - Centre d'Investigation Clinique [Rennes]
19 CHU Pontchaillou [Rennes]
20 Service de Neurologie [CHU Caen]
21 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]
22 JPArc - Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U1172 Inserm - U837
23 CHU Rouen
24 Service de neurologie [CHU de Saint-Étienne]
25 Service de Neurochirurgie [CHU Limoges]
26 Service de neuroradiologie [Tours]
27 APEMAC - Maladies chroniques, santé perçue, et processus d'adaptation
28 Service de neurologie [CHRU Nancy]
29 Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon)
30 Fondation Ophtalmologique Adolphe de Rothschild - Service de neurologie [Paris]
31 Service de Neurologie [CHU de Poissy]
32 Service de neurologie 1 [CHU Pitié-Salpétrière]
33 HCL - Hospices Civils de Lyon, Departement de Neurologie
34 CRNL - Centre de recherche en neurosciences de Lyon
35 UCBL - Université Claude Bernard Lyon 1
Abstract : High-dose biotin (HDB) is a therapy used in non-active progressive multiple sclerosis (PMS). Several reports have suggested that HDB treatment may be associated with an increased risk of relapse. We aimed to determine whether HDB increases the risk of clinical relapse in PMS and describe the characteristics of the patients who experience it. We conducted a French, multicenter, retrospective study, comparing a group of PMS patients treated with HDB to a matched control group. Poisson regression was applied to model the specific statistical distribution of the annualized relapse rate (ARR). A propensity score (PS), based on the inverse probability of treatment weighting (IPTW), was used to adjust for indication bias and included the following variables: gender, primary PMS or not, age, EDSS, time since the last relapse, and co-prescription of a DMT. Two thousand six hundred twenty-eight patients treated with HDB and 654 controls were analyzed with a follow-up of 17 +/- 8 months. Among them, 148 validated relapses were observed in the group treated with biotin and 38 in the control group (p = 0.62). After adjustment based on the PS, the ARR was 0.044 +/- 0.23 for the biotin-treated group and 0.028 +/- 0.16 for the control group (p = 0.18). The more relapses there were before biotin, the higher the risk of relapse during treatment, independently from the use of HDB. While the number of relapses reported for patients with no previous inflammatory activity receiving biotin has gradually increased, the present retrospective study is adequately powered to exclude an elevated risk of relapse for patients with PMS treated with HDB.
Keywords : Relapse Propensity score Biotin Progressive multiple sclerosis Clinical trials observational study
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https://hal.archives-ouvertes.fr/hal-02995967
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Submitted on : Thursday, November 19, 2020 - 12:04:45 PM
Last modification on : Thursday, January 14, 2021 - 4:20:03 PM

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UNIV-NANTES | UNIV-RENNES | CRTI | APEMAC-UL | CNRS | UDL | PRES_CLERMONT | COMUE-NORMANDIE | BMS-UL | UNIV-RENNES1 | UNIV-LYON1 | UNIV-ST-ETIENNE | UR1-UFR-SVE | CIC203 | ND | BIOSIT | CIC | HCL | UNIV-LORRAINE | ACL-SVSAE | UNIV-TLSE3 | UNIV-MONTPELLIER | UNICAEN | SITE-ALSACE | SORBONNE-UNIVERSITE | SU-TI | UNIV-LILLE

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Sophie Mathais, Xavier Moisset, Bruno Pereira, Frederic Taithe, Jonathan Ciron, et al.. Relapses in Patients Treated with High-Dose Biotin for Progressive Multiple Sclerosis. Neurotherapeutics, Springer Verlag, 2020, ⟨10.1007/s13311-020-00926-2⟩. ⟨hal-02995967⟩

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