1- خبري در مورد كارت هوشمند كه مستقيماً هم اشاره ميكنه ام اس جزو بيماري هاي خاص منظور شده.
2- دوستي برام ايميل زده و اين خبر رو به اينصورت نوشته كه “بتازگي يك داروي جديد براي درمان ام اس يافت شده كه از آونكس Avonex قويترست و اسم آن تيزابري Tysabri است. اين دارو در حال حاضر فقط در انگلستان موجود مي باشد.
اينم اصل خبر
NEW | 2006-08-30
The MS Trust welcomes NICE’s decision to use the rapid STA process for the assessment of Tysabri for the treatment of multiple sclerosis
The MS Trust welcomes the decision by the National Institute for Health and Clinical Excellence (NICE) to use their new rapid Single Technology Appraisal (STA) process for the assessment of Tysabri (natalizumab) for the treatment of relapsing remitting multiple sclerosis (MS).
This process has only recently been developed and allows assessment to be undertaken within a six month period rather than a normal assessment period which can be as long as two years.
Tysabri, manufactured by Biogen Idec/Elan, was given a licence on 29 June by the European Medicines Agency (EMEA) and is now available in the UK.
Christine Jones, Chief Executive of the MS Trust, said: “The MS Trust is delighted that NICE has decided to use the new STA process for the assessment of Tysabri. After the very lengthy process that we had to endure with the NICE assessment of the current disease modifying drug therapies I am delighted that in this instance the process will be rapid.”
Tysabri is a powerful immuno-suppressant, which has shown dramatic results in the treatment of MS. The medicine is the first monoclonal antibody to be licensed for MS, but concerns were raised when in the clinical trial phase there were two cases, one fatal, of progressive multifocal leukoencephalopathy (PLM) in patients who had received the drug in combination with Avonex (interferon beta-1a) as part of a two-year clinical trial.
The licence indication is that Tysabri will be used as a single therapy for:
Patients who have failed to respond to a full and adequate course of beta interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have evidence of lesions on their MRI scan.
Patients with rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in one year and with evidence of increasing lesions on two consecutive MRI scans.
Mark Priest, 32, works as an accountant. His wife, 34, has MS and had been taking Tysabri within a clinical trial.
Mark said: “It was a setback when Tysabri was withdrawn, although we had already decided to come off the drug at the end of the two year trial as we were considering starting a family. When she was on the drug, she was well, her MS was mild and we lived a carefree life. She was running and swimming regularly, she was healthy and we didn’t really have to think about her MS.
“Since coming off the drug she has relapsed. This year she has been very poorly. She’s having difficulty walking and had an increased number of sensory relapses.
“I think that we would consider going back on the drug but we would certainly want more information about side-effects and how other people’s experience of their MS has been since ceasing treatment, as it is difficult to understand potential side effects in the absence of any comparable information across a group of people.
“New treatments which offer hope for people with MS are to be welcomed. We have just had our first baby and so this could give us as a family a good opportunity in the future,” Mark said.
Christine Jones said: “The long-term safety of Tysabri is not yet well documented therefore the MS Trust will strongly support close monitoring to reduce the risk of side-effects and to look at long-term safety and efficacy.
“Until long term data becomes available both people with MS and clinicians will need to proceed with caution,” she said.
ENDS
Notes to Editors
MS Trust
The MS Trust was established in 1993 to provide practical and relevant support for people with MS. Since its foundation, the MS Trust has grown from small beginnings as a research-based organisation with no paid employees, to a leading, independent national charity that is in regular contact with over 22,000 people in the MS community.
The MS Trust is committed to the proactive management of MS from the time of diagnosis and aims to support anyone affected by MS, either personally or professionally. It is active in four key areas: information provision; professional education; policy and campaigning; and research
Tysabri
Tysabri is the first in a new class of monoclonal antibody drugs for the treatment of multiple sclerosis. It has been shown to have significant advantages over current MS therapies in reducing relapse rates and slowing down progression to disability.
In a two-year study, AFFIRM*, of nearly 1,000 patients, the annual rate of clinical relapse was reduced by 68% and the number of new or enlarging brain lesions was reduced by 83% (ref). To put this in perspective, the currently used drugs, interferon and glatiramer, reduce acute attacks by roughly one third (ref).
In addition, Tysabri reduced the risk of progression of disability. Only 17% of the patients on Tysabri had become worse compared to 29% of patients on placebo.
Similar results are shown in another two year trial, SENTINEL**, of over 1,000 patients where Tysabri was given in conjunction with beta interferon 1a. The trial showed a 24% reduction in the risk of disability progression and a 56% reduction in clinical relapses.
The FDA originally approved Tysabri in November 2004 for the treatment of MS but its use was voluntarily suspended by the manufacturers, Biogen Idec and Elan in February 2005 following three deaths due to progressive multi-focal leukoencaphalopathy (PML), which were attributed to the drug.
* Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM)
** Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL)
PML
Progressive multifocal leukoencephalopathy is an extremely debilitating demyelination disease of the central nervous system. It is characterised by neurological deficits the progress rapidly but without signs of intracranial pressure. Symptoms may include hemiparesis, cognitive disturbance, visual field deficits, ataxia, aphasia, cranial nerve deficits and sensory deficits. Patients usually deteriorate rapidly and death commonly occurs within 6 months of diagnosis. Some patients, however, do experience fluctuating symptomatology over a 2-3 year people. It is thought that PML is linked to opportunistic infection with the JC virus (a human polyomavirus). Around 60-80% of adults have antibodies to the JC virus but it generally lies dormant. Immunosuppression may reactive the virus.
The true risk of getting PML is unknown outside of the clinical trials of people taking Tysabri. According to a study published in The New England Journal of Medicine (The New England Journal of Medicine 2006;354:924-933.), the risk in the clinical trials population, who had taken an average of 17.9 doses of Tysabri, is one in one thousand.