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Skin Patches to Treat MS
August 29, 2013   
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In a world first, a group of Polish neurologists from the central city of £ód¼ have used special skin patches with what are known as myelin components to treat patients with multiple sclerosis—and the results are promising.

Their experimental method has been recognized by international healthcare authorities as a smart, efficient and safe weapon in the fight against multiple sclerosis.

The researchers, led by Prof. Krzysztof Selmaj and hailing from the Department of Neurology at the Medical University of £ód¼ in central Poland, have already patented their method.

According to the researchers, a skin patch delivering a mixture of three myelin peptides significantly reduces disease activity in patients with relapsing-remitting multiple sclerosis.

The study found a significant reduction in the annual relapse rate (ARR) in patients wearing the myelin peptide patch for a year.

According to Selmaj, “the myelin peptide patch is an attractive and promising therapeutic approach.” Unlike current multiple sclerosis (MS) drugs that inhibit a major immune function and often eliminate a wide array of immune cells, the myelin peptide patch targets MS-related antigens while sparing mechanisms critical for immune protection, Selmaj says.

An estimated 60,000 people in Poland have multiple sclerosis. The course of disease in each patient is different. It sometimes makes them disabled and always makes their life difficult and unpredictable.

The most common form of the disease is so-called relapsing-remitting MS, which affects almost 60 percent of the patients.

Until now, pharmacological treatment of multiple sclerosis was based on the use of drugs such as beta interferon and glatiramer acetate, but their effectiveness leaves much to be desired, according to doctors. Also used in the treatment of the disease are other drugs such as fingolimod and natalizumab, but these too, though more effective and safer, may expose the patient to adverse effects.

The method developed by the Polish scientists for the treatment of MS may prove to be revolutionary.

In developing their method, the £ód¼ researchers worked together with Prof. Marian Szczepanik from the Jagiellonian University in Cracow and conducted a pilot clinical trial of 30 patients with relapsing-remitting MS. Of this, 20 patients were given skin patches delivering a mixture of three myelin peptides directly to the skin of their arms for a year. At the same time, a control group of 10 patients were administered placebo patches in the form of physiological saline. For the first four weeks the patches were changed once a week, and over the next 11 months they were changed once a month. Neither the patients nor the doctors knew who was using the placebo patches, and who had patches with peptides.

The researchers reported the results of their study online in the JAMA Neurology journal, concluding that skin patches delivering peptides helped reduce relapse frequency and brain lesions.

In 30 patients with relapsing-remitting MS enrolled in the one-year, placebo-controlled trial, those receiving the myelin skin patches containing 1 mg of peptides had an annualized relapse rate of 0.43 versus 1.4 in patients treated with a placebo patch, according to Selmaj and colleagues.

Overall, they concluded that “the efficacy and safety profiles that have emerged from this study make the transdermal application of a mixture of three myelin peptides an attractive and promising therapeutic approach in patients with relapsing-remitting MS.”

The researchers also suggested that myelin peptide delivery would spare other mechanisms critical for immune protection.

In an accompanying commentary, Lawrence Steinman, MD, of Stanford University, called the results “promising” and added that they were consistent with what many in the field have considered the Holy Grail in MS: the induction of immunological tolerance.

“The thing about multiple sclerosis is that the patient’s immune system attacks the person’s own myelin components,” says Selmaj. “Thus, if we administer these components directly to the skin in a continuous and repeatable way, then, to some extent, colloquially speaking, the body will stop being sensitive to these components. Simply the immune system will gradually learn to tolerate them, putting an end to the process whereby the body’s own immune system launches an attack on itself.” Selmaj likened the approach to desensitization in allergy, where exposure to allergens reduces or eliminates allergic reactions.

Selmaj added, “Our method is innovative in that we only inhibit reactions targeted against myelin. All other functions of the immune system remain intact. This is a huge advantage compared with other drugs currently used in treating patients with MS, which, to a greater or lesser extent, inhibit the immune system as a whole. This deprives the patient of the possibility of defending themselves against dangerous infections.”

The £ód¼ neurologists began working on their method in 2007. When at the end of their yearlong study they compared the results for all the patients, it turned out that the patients treated with the skin patches had 70 percent fewer relapses and 70 percent fewer sites of inflammation indicative of the progress of multiple sclerosis.

“This form of treatment has a very significant effect on inhibiting the activity of the disease,” says Selmaj. “It reduces the number of attacks and the number of inflammatory lesions in the brain. It also inhibits the progression of disability and is completely safe.”

Agnieszka Dokowicz


Factfile

Multiple sclerosis (MS) is an inflammatory disease that affects the nerve cells in the brain and spinal cord, causing damage that disrupts the ability of parts of the nervous system to communicate. It can result in a variety of physical and mental problems such as loss of muscle control, vision and balance, or in numbness, hand tremors, general weakness, a feeling of constant tiredness and memory problems.

MS is an autoimmune disease, a condition in which the body’s immune system, which normally targets and destroys substances foreign to the body such as bacteria, mistakenly attacks normal tissues. In MS, the immune system attacks the brain and spinal cord, the two components of the central nervous system.

The central nervous system is made up of nerves that act as the body’s messenger system. Each nerve is covered by a fatty substance called myelin, which insulates the nerves and helps in the transmission of nerve impulses, or messages, between the brain and other parts of the body. These messages control muscle movements. MS gets its name from the buildup of scar tissue (sclerosis) in the brain and/or spinal cord. The scar tissue or plaques form when the protective and insulating myelin covering the nerves is destroyed, a process called demyelination. Without the myelin, electrical signals transmitted throughout the brain and spinal cord are disrupted or halted. The brain then becomes unable to send and receive messages.

Although the nerves can regain myelin, this process is not fast enough to outpace the deterioration that occurs in MS. The types of symptoms, severity of symptoms, and the course of MS vary widely, partly due to the location of the scar tissue and the extent of demyelination.

Scientists do not know what causes MS. It is believed to occur as a result of a combination of environmental factors and genetics. It is only known for a fact that the disease affects mostly young people between 20 and 40 years of age, more often women than men.
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