Transdermal Application of Myelin Peptides in Multiple Sclerosis Treatment

Abstract

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.

Original article Effect of oral administration of pig spinal cord hydrolysate on clinical and histopathological symptoms of experimental allergic encephalomyelitis in rats

“…Peptide fragments of three main myelin proteins, MBP, PLP and MOG, were given to patients transdermally, using patches stuck to the skin of the arm. There was a reduction in the number of lesions visible in MRI imaging and the annual relapse rate in patients treated transdermally with myelin antigens in comparison to the placebo group [15,38].…”

Nano- and micro-based systems for immunotolerance induction in multiple sclerosis

“…40 Moreover, a small trial enrolling 14 MS patients showed that the passive diffusion of myelin-related peptides through the skin induces some improvements in the disease, namely reducing the incidence of relapses and the area of lesion (assessed by MRI). 41 These findings highlight the potential of this route of administration in immunotolerance-based therapies (Figure 1).…”

Immunology: A tolerant approach

“…Compared with a placebo, the treatment achieved a statistically significant drop in MS disease activity, as measured by magnetic resonance imaging of the brain. Patients assigned to the therapy also had far fewer relapses 10 .…”