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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
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.
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Submitted on : Thursday, November 19, 2020 - 12:04:45 PM
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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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