10 November 2011

Monoclonal antibodies against psoriasis

A new biological drug for the treatment of moderate and severe plaque psoriasis – Stelara (ustekinumab) has appeared in Russia, combining a unique safety profile comparable to placebo and ease of use: subcutaneous injections 1 time every 12 weeks. The drug, which is 100% monoclonal human antibodies, opens a new class of drugs for the treatment of psoriasis.

Psoriasis is a chronic immune–mediated disease in which excessive growth of skin cells occurs. They accumulate on the surface of the skin and form red scaly plaques that can crack and bleed. It is estimated that approximately 3% of the world's population lives with psoriasis, and about a quarter of these people have cases that are regarded as moderate or severe. Most often, psoriasis occurs at the age of 15 to 25 years, but it can develop later. One of the varieties of psoriasis is plaque psoriasis. It usually manifests itself in areas of thickened, red or inflamed skin covered with silver scales. These plaques usually cause itching or a feeling of pain, can crack and bleed, can occur anywhere on the surface of the body. The symptoms of the disease can range from mild to severe and disabling. Localization areas: elbows, knees, groin area, face, scalp, feet and palms.

Currently, psoriasis is one of the most common chronic dermatoses, which affects about 125 million people worldwide. Scientists believe that disorders of the immune response play a key role in the development of psoriasis (the inflammatory psoriatic process has an immune nature with a violation of the functions of T cells).
Psoriasis worsens the quality of life: patients experience significant physical and psychological discomfort, they have great difficulties with social and professional adaptation. As a rule, they are overly concerned about their appearance, suffer from low self-esteem and depression, which can lead to thoughts of suicide. Patients with psoriasis are prone to increased consumption of alcohol and tobacco, which increases the percentage of mortality among patients.

According to the results of a study by the European Association of Patients with Psoriasis (EUROPSO), which involved about 18,000 patients with psoriasis, 77% reported their dissatisfaction with the available treatments, despite the fact that they were generally satisfied with the work of their doctors. Patients consider the most difficult aspects of treatment to be its labor intensity (50%) (the need to take medications daily and use local therapy – ointments, creams), as well as inefficiency (32%).

A breakthrough in the treatment of psoriasis are biological drugs that block the action of certain cells of the immune system, which play a key role in the development of the disease. Biological therapy allows you to achieve the main therapeutic goal – long-term remission and complete cleansing of the skin from the manifestations of psoriasis.

At the moment, the biological drug Stelara is registered in 27 member countries of the European Union for the treatment of moderate and severe plaque psoriasis. The drug Stelara as an innovative product was awarded the prestigious Galena Award two years in a row in 2010 and 2011, which is recognition of innovative biomedical achievements in pharmaceuticals that are important both for patients and for healthcare in general.

Stelara has a highly selective mechanism of action that affects the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23) – proteins that play a key role in the development of psoriasis. Thus, acting at an earlier stage of the development of inflammation, the drug provides a quick and lasting effect. Improvements become noticeable to the patient (according to subjective feelings) already 2 weeks after the 1st injection. The effectiveness is maintained for a long period of time, with maintenance therapy every 12 weeks.

Unlike other biological preparations, Stelara has a unique composition of the molecule, which is 100% monoclonal human antibodies, which are perceived by the body as its own immunoglobulin. This ensures an optimal safety profile comparable to placebo, a low incidence of adverse events compared to other biological drugs for the treatment of psoriasis.

The efficacy, safety and tolerability of Stelara in the treatment of moderate and severe forms of plaque psoriasis were studied in 1996 patients in 2 multicenter, randomized, placebo-controlled double-blind phase III clinical trials PHOENIX 1 and PHOENIX 2.

The results of the studies indicate that the PASI index of 75 was achieved in patients receiving Stelara (skin cleansing by 75% compared to the initial state) at week 12 (after 2 injections), which persisted for at least one year with maintenance therapy every 12 weeks.

This innovative approach to psoriasis therapy opens up good prospects for its widespread implementation in medical practice. Currently, the drug Stelara is also undergoing research for the treatment of psoriatic arthritis, Crohn's disease and sarcoidosis.

Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of the Janssen company.

10.11.2011

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