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Original Investigation |

Transdermal Application of Myelin Peptides in Multiple Sclerosis Treatment

Agata Walczak, MD, PhD1; Malgorzata Siger, MD, PhD1; Agnieszka Ciach, MD, PhD1; Marian Szczepanik, PhD2; Krzysztof Selmaj, MD, PhD1
[+] Author Affiliations
1Department of Neurology, Medical University of Lodz, Lodz, Poland
2Department of Medical Biology, Jagiellonian University College of Medicine, Krakow, Poland
JAMA Neurol. 2013;70(9):1105-1109. doi:10.1001/jamaneurol.2013.3022.
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Published online

Importance  Demonstration of efficacious antigen-specific therapy in multiple sclerosis.

Objective  To assess the safety and efficacy of transdermally applied myelin peptides in patients with relapsing-remitting multiple sclerosis.

Design  One-year double-blind, placebo-controlled cohort study.

Setting  Referral center.

Participants  Thirty outpatients aged 18 to 55 years with relapsing-remitting multiple sclerosis.

Intervention  Skin patch with a mixture of 3 myelin peptides, MBP85-99, MOG35-55, and PLP139-155.

Main Outcomes and Measures  Cumulative number of active gadolinium-enhanced (Gd+) lesions per patient per scan, mean volume of Gd+ lesions, cumulative number of new T2 lesions, and T2 lesion and T1 lesion volume change from baseline to the end of the study. Total number of relapses during the year of the study per patient (annual relapse rate), proportion of relapse-free patients, and proportion of patients with 3 months of confirmed disability worsening on the Expanded Disability Status Scale at month 12.

Results  All patients completed the study. Compared with placebo, treatment with a myelin peptide skin patch (1 mg) showed a 66.5% reduction in the cumulative number of Gd+ lesions (P = .02) during the 12 months of the study. The annual relapse rate in patients treated with a mixture of myelin peptides (1 mg) was significantly lower compared with the placebo group (0.43 vs 1.4; P = .007). Treatment with a myelin peptide skin patch was well tolerated and no serious adverse events were reported.

Conclusions and Relevance  In patients with relapsing-remitting multiple sclerosis, treatment with a myelin peptide skin patch significantly reduced both magnetic resonance imaging and clinically defined measures of disease activity and was safe and well tolerated.

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