new advice may help early detection of pml and improve patients rsquo outcomes ema rsquo s pharmacovigilance risk assessment committee prac has completed its review of the risk of progressive multifocal leukoencephalopathy pml with the multiple sclerosis medicine tysabri natalizumab and has recommended new measures to minimise this risk. Pml is a rare and very serious brain infection caused by john cunningham jc virus. Recent studies suggest that early detection and treatment of pml when the disease is asymptomatic is still in the initial stages and shows no symptoms are critically important in limiting the degree of brain damage and resulting disability caused by the disease. On the basis of this data, the prac concluded that for patients at higher risk of pml more frequent mri scans e.g. Known risk factors for the development of pml in patients treated with tysabri are the presence of antibodies against jc virus a sign that a person has been exposed to the virus , treatment with tysabri for more than two years, and use of immunosuppressant medicines medicines that reduce the activity of the immune system before starting tysabri.

New data from clinical studies suggest that, in patients who have not been treated with immunosuppressants before starting tysabri, the level of antibodies index relates to the level of risk for pml. More specifically, current evidence suggests that the risk of pml is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with tysabri for longer than 2 years. Therefore, the prac concluded that patients with a high antibody index who have not used immunosuppressants before tysabri and have been treated with tysabri for more than 2 years are also considered at higher risk of pml. In patients at higher risk of developing pml, treatment with tysabri should only be continued if benefits outweigh the risks. For patients who have a low antibody index and have not used immunosuppressant medicines before starting tysabri, the prac recommends repeating the antibody test every 6 months once they have taken tysabri for longer than 2 years. In patients who tested negative for jc virus antibodies, the antibody test should be repeated every 6 months.

If pml is suspected at any time, treatment with tysabri must be stopped until pml has been excluded. The prac recommendation will now be forwarded to the committee for medicinal products for human use chmp for the adoption of ema final opinion. Further details including advice for patients and healthcare professionals will be published at the time of the chmp opinion. Tysabri is a medicine used to treat adults with highly active multiple sclerosis ms , a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. Tysabri is used in the type of ms known as lsquo relapsing remitting rsquo ms, when the patient has attacks relapses in between periods with no symptoms remissions.

It is used when the disease has failed to respond to treatment with a beta‑interferon or glatiramer acetate other types of medicines used in ms , or is severe and getting worse rapidly. The active substance in tysabri, natalizumab, is a monoclonal antibody a type of protein that has been designed to recognise and attach to a specific part of a protein called lsquo α4β1 integrin rsquo. This is found on the surface of most leucocytes the white cells in the blood that are involved in the inflammation process. By blocking the integrin, natalizumab stops the leucocytes from going from the blood into the brain. The review of tysabri was initiated on 7 may 2015 at the request of the european commission, under article 20 of regulation ec no 726/2004. The review has been carried out by the pharmacovigilance risk assessment committee prac , the committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations. During its assessment, the prac sought the advice of a group of experts in neurology.

The prac recommendations will now be sent to the committee for medicinal products for human use chmp , responsible for questions concerning medicines for human use, which will adopt the agency rsquo s final opinion. The final stage of the review procedure is the adoption by the european commission of a legally binding decision applicable in all eu member states. Progressive multifocal leukoencephalopathy pml is a demyelinating disease of the cns characterized by widespread lesions due to infection of oligodendrocytes by a human papovavirus.

The virus was identified as the etiological agent in 1967 and is named jc virus in 1971 after john cunningham, from whom it was first isolated. It occurs almost exclusively in immunosuppressed individuals, such as patients with aids, hematological and lymphoreticular malignancies, autoimmune rheumatological diseases, or those undergoing organ transplantation. Pml has also been reported in patients receiving immune therapy with monoclonal antibodies eg, natalizumab, rituximab and various other immunosuppressants, including prednisone, cyclophosphamide, methotrexate, and cyclosporine. 2, 3 hiv infection accounts for almost 85% of the total cases, and its prevalence in this population is around 4 5%.

Pml Review Article Text

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