A study published last year raised hopes that MD1003, high-dose biotin, could reverse disability in some patients with progressive multiple sclerosis (MS), but new research urges caution in prescribing the therapy.

Biotin pills. (Source: Creative Commons)

Researchers from the University of Parma in Italy found an “unexpected increase of inflammatory activity” associated with high-dose biotin therapy. They will present their study on October 26 at the 2017 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting in Paris (poster 750).

The study included 41 patients with progressive MS (PPMS) treated with oral high-dose biotin for a mean of 13.7 months. Participants had an average age of 54 and 22 were female. Of the patients, 39% had primary progressive MS 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, and nine 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, EDSS scores rose in one, while 17 remained stable and 10 declined.

The investigators said that progressive MS patients treated with high-dose biotin experienced an unexpectedly high rate of inflammatory activity as seen by both clinical relapse rates and radiological activity.

“Clinicians should be very cautious when prescribing this drug until its efficacy and safety are definitely proven,” they said.