Early study results created great excitement about biotin as a treatment for progressive multiple sclerosis, which has had few approved therapies. While some follow-up studies supported the use of biotin, not all the news is good. Research presented at a major MS conference showing increased inflammation and a dramatic increase in relapse rate for progressive MS patients taking biotin—and FDA concerns—urges a more tempered approach. As the bulk of consumer-targeting materials discussing biotin have included no caveats, your patients may not be aware of the potential issues. Read more.

A study published last year raised hopes that MD1003, high-dose biotin (also known as B7, vitamin H, or coenzyme R), could reverse disability in some patients with primary-progressive multiple sclerosis (PPMS) without serious adverse effects, but new research urges caution in prescribing the therapy. Based on the earlier results, some physicians have prescribed high doses of biotin and some patients may have sought to improve their MS through high consumption of biotin through supplements commonly available OTC at pharmacies.

A more recent study that found an “unexpected increase of inflammatory activity” associated with high-dose biotin therapy was presented at the 2017 joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The investigators noted that PPMS patients treated with high-dose biotin experienced sharp increases in both clinical relapse rates and radiological activity. They advised that “Clinicians should be very cautious when prescribing this drug until its efficacy and safety are definitely proven.”

In addition, the FDA issued a Safety Alert on November 28, 2017, warning that biotin can “cause clinically significant incorrect lab test results.” Falsely high or falsely low test results may lead to misdiagnosis or disease mismanagement. According to the alert, “The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.” The recommended daily allowance for biotin is 0.03 mg.

The ECTRIMS study included 41 patients with PPMS treated with oral high-dose biotin (300 mg) for a mean of 13.7 months. Participants had an average age of 54 years, and 22 were female. Of the patients, 39% had PPMS and 61% had secondary progressive MS.

The annualized relapse rate nearly tripled, rising from 0.10 in the previous year to 0.27 during treatment with high-dose biotin. Twelve relapses occurred in nine patients, including two patients with PPMS who had never had an MS attack. Nine of the relapses required steroid therapy. Of the patients who experienced relapses, four suffered residual disability. New or enlarged T2 or Gd+ lesions were detected by MRI in seven patients, and three of them experienced relapses. Of the 28 patients who remained on high-dose biotin for a year or longer, Expanded Disability Status Scale scores rose in one, while 17 remained stable and 10 declined.

The investigators noted that PPMS patients treated with high-dose biotin experienced an unexpectedly high rate of inflammatory activity as seen by both clinical relapse rates and radiological activity. They noted that “clinicians should be very cautious when prescribing this drug until its efficacy and safety are definitely proven.”

A multicenter, international phase III trial evaluating the efficacy of biotin in MS is in progress, but the results from this small study urge caution in the use of high-dose biotin, which can be made at compounding pharmacies, or high doses of OTC biotin supplements outside of a clinical trial.

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