Abstract
Objective: Report and identify relationship between high doses of biotin and a potential pro-inflammatory effect in progressive multiple sclerosis (PMS).
Background: High doses of biotin represent an effective treatment in patients with not-active PMS with a confirmed reduction in MS-related disability. Radiological data in the placebo-controlled pivotal study may suggest a potential pro-inflammatory effect of biotin (Tourbah, 2016).
Design/Methods: Identify in MS centers PMS patients with stable disease who developed unexpected clinical and/or radiological inflammatory activity under high doses of biotin.
Results: First five PMS patients were identified (3 women and 2 men, 51 to 62 years, 8 to 23 years of disease duration). All had similar stable disease without clinical or radiological activity and received high doses of biotin. A relapse with new T2 and/or gadolinium-enhancing brain lesions on MRI occured in all patients after 3 to 7 months of treatment exposure. Biotin was stopped due to a potential adverse effect.
Conclusions: High doses of biotin in PMS could have a potential pro-inflammatory effect. In the pivotal placebo-controlled study, more new or enlarging MRI lesions occurred in the treated arm than in the placebo arm (23.4% vs 13.0% respectively, p=0.36) with more relapses in the extension phase (6.6% in the treated arm vs 4.8% in the placebo arm). A recent case report of solitary sclerosis showed also new T2 lesions after 2 years of biotin. Even if clinical or radiological activity were also present in PMS without treatment, relapses after recent introduction of biotin in not-active MS patients challenge the question of a potential relationship. Follow-up of PMS patients initiating high doses of biotin in a real life setting should include careful assessment of MRI activity to monitor pro-inflammatory effect of biotin. This monitoring may be recommended before and shortly after introduction of biotin to detect new T2 and/or gadolinium-enhancing lesions.
Disclosure: Dr. Branger has nothing to disclose. Dr. Derache has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck Serono, Biogen, Novartis, Teva, Sanofi-Genzyme. Dr. Kassis has nothing to disclose. Dr. Maillart has nothing to disclose. Dr. Assouad has nothing to disclose. Dr. Defer has nothing to disclose.
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