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… Show more
“…Although the subgroup of patients with primary progressive MS was small and no statistically significant conclusions could be drawn from this cohort, biotin seems to have been used more frequently among these patients, since these were the study groups in clinical biotin trials. 6–9 An information guide on the use of vitamin D and biotin with evidence in favour of and against their supplementation is provided in Box 1.Information guide on the use of vitamin D and biotin in multiple sclerosis.…”
Section: Discussionmentioning
confidence: 99%
“… 6 A subsequent placebo-controlled study with 154 patients showed sustained reversal of MS-related disability in a subset of patients with progressive MS upon intake of 300 mg biotin per day. 7 On the other hand, two prospective studies reported no benefit of high-dose biotin on disability in progressive MS. 8 , 9 Failure to meet primary and secondary endpoints was also preliminarily reported from a large Phase III trial in progressive MS (NCT02936037). 10…”
Section: Introductionmentioning
confidence: 93%
“…6 A subsequent placebo-controlled study with 154 patients showed sustained reversal of MS-related disability in a subset of patients with progressive MS upon intake of 300 mg biotin per day. 7 On the other hand, two prospective studies reported no benefit of high-dose biotin on disability in progressive MS. 8,9 Failure to meet primary and secondary endpoints was also preliminarily reported from a large Phase III trial in progressive MS (NCT02936037). 10 In the meantime, as at least low-dose biotin is available over-the-counter as a supplement for hair and nails, self-medication is discussed frequently in the media and internet forums for patients with MS. Far from being a harmless vitamin supplement, however, biotin (at least in high doses) not only causes side effects such as myopathy, 11 but also interferes with a considerable number of common laboratory assays.…”
Section: Introductionmentioning
confidence: 95%
“…For the second week, the dosage used in pharmacological studies for treatment of progressive MS (300 mg/day) was selected. [6][7][8][9] Blood samples were taken at baseline and after 1 and 2 weeks. Biotin concentration in serum was analysed by an external laboratory.…”
Background As vitamins and dietary supplements are obtainable without prescription, treating physicians often ignore their intake by patients with multiple sclerosis (MS) and may therefore miss potential adverse effects and interactions. Objective We aimed to assess the spectrum and intake frequency of supplementary medication in a cohort of MS patients and to analyse the effect of biotin intake on measurement of serum neurofilament light chain (sNfL), an emerging marker of disease activity. Methods MS patients visiting our neurology outpatient clinic completed a questionnaire on their past or present use of vitamins or dietary supplements. In addition, the impact of two different doses of biotin (10 and 300 mg/day) on sNfL was studied in healthy volunteers. Results Of 186 patients, 72.6% reported taking over-the-counter vitamins or dietary supplements currently or previously. Most frequently used was vitamin D (60.0%), followed by biotin. Female patients and patients with primary progressive MS tended to use supplements more frequently. Biotin intake did not interfere with sNfL measurement by single molecule array (Simoa). Conclusions The use of vitamins and dietary supplements is frequent among patients with MS. Thus, treating physicians should be aware of the pitfalls of supplementary treatment and educate their patients accordingly.
“…Although the subgroup of patients with primary progressive MS was small and no statistically significant conclusions could be drawn from this cohort, biotin seems to have been used more frequently among these patients, since these were the study groups in clinical biotin trials. 6–9 An information guide on the use of vitamin D and biotin with evidence in favour of and against their supplementation is provided in Box 1.Information guide on the use of vitamin D and biotin in multiple sclerosis.…”
Section: Discussionmentioning
confidence: 99%
“… 6 A subsequent placebo-controlled study with 154 patients showed sustained reversal of MS-related disability in a subset of patients with progressive MS upon intake of 300 mg biotin per day. 7 On the other hand, two prospective studies reported no benefit of high-dose biotin on disability in progressive MS. 8 , 9 Failure to meet primary and secondary endpoints was also preliminarily reported from a large Phase III trial in progressive MS (NCT02936037). 10…”
Section: Introductionmentioning
confidence: 93%
“…6 A subsequent placebo-controlled study with 154 patients showed sustained reversal of MS-related disability in a subset of patients with progressive MS upon intake of 300 mg biotin per day. 7 On the other hand, two prospective studies reported no benefit of high-dose biotin on disability in progressive MS. 8,9 Failure to meet primary and secondary endpoints was also preliminarily reported from a large Phase III trial in progressive MS (NCT02936037). 10 In the meantime, as at least low-dose biotin is available over-the-counter as a supplement for hair and nails, self-medication is discussed frequently in the media and internet forums for patients with MS. Far from being a harmless vitamin supplement, however, biotin (at least in high doses) not only causes side effects such as myopathy, 11 but also interferes with a considerable number of common laboratory assays.…”
Section: Introductionmentioning
confidence: 95%
“…For the second week, the dosage used in pharmacological studies for treatment of progressive MS (300 mg/day) was selected. [6][7][8][9] Blood samples were taken at baseline and after 1 and 2 weeks. Biotin concentration in serum was analysed by an external laboratory.…”
Background As vitamins and dietary supplements are obtainable without prescription, treating physicians often ignore their intake by patients with multiple sclerosis (MS) and may therefore miss potential adverse effects and interactions. Objective We aimed to assess the spectrum and intake frequency of supplementary medication in a cohort of MS patients and to analyse the effect of biotin intake on measurement of serum neurofilament light chain (sNfL), an emerging marker of disease activity. Methods MS patients visiting our neurology outpatient clinic completed a questionnaire on their past or present use of vitamins or dietary supplements. In addition, the impact of two different doses of biotin (10 and 300 mg/day) on sNfL was studied in healthy volunteers. Results Of 186 patients, 72.6% reported taking over-the-counter vitamins or dietary supplements currently or previously. Most frequently used was vitamin D (60.0%), followed by biotin. Female patients and patients with primary progressive MS tended to use supplements more frequently. Biotin intake did not interfere with sNfL measurement by single molecule array (Simoa). Conclusions The use of vitamins and dietary supplements is frequent among patients with MS. Thus, treating physicians should be aware of the pitfalls of supplementary treatment and educate their patients accordingly.
“…Couloume and colleagues 1 have provided further evidence that very high doses of biotin do not improve the vast majority of individuals with progressive multiple sclerosis in a large cohort. These findings support those of a previous study of 43 individuals with the disorder who, for the most part, also did not improve on enormous doses of biotin.…”
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.
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