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

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. 2,628 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.

Biomarkers of treatment response in patients with progressive multiple sclerosis treated with high‐dose pharmaceutical‐grade biotin (MD1003)

“…Another explanation could lie in the exacerbation of inflammation under MD1003. This point is a matter of debate, because the studies on this topic are contradictory, for example, one showing a relationship (Branger et al., 2020) and another showing none (Mathais et al., 2020). Whatever the case, the increase in brain volume or in the level of pNfL was not associated with the occurrence of relapses in our study.…”

Novel Drugs in a Pipeline for Progressive Multiple Sclerosis

“…On the other hand, a retrospective multicenter French study of 2628 PMS patients compared to a control group of 654 patients was conducted to analyze the relapse rate during biotin therapy. Even though the number of relapses in patients without previous inflammatory activity gradually increased while taking biotin, the results of the study excluded the possibility of an increased risk of relapses during biotin therapy [ 23 ].…”

Macronutrients, vitamins and minerals in the diet of multiple sclerosis patients

“…It has been hypothesized to compete with the metabolism or transport of B vitamins, including riboflavin, which are involved in cell function [71]. However, the results are still inconclusive [72]. Motte et al concluded in their study that a high oral dose of biotin cannot be recommended for patients with progressive multiple sclerosis and that further research on biotin is no longer needed [73].…”

“…It has been hypothesized to compete with the metabolism or transport of B vitamins, including riboflavin, which are involved in cell function [ 71 ]. However, the results are still inconclusive [ 72 ]. Motte et al .…”