voor de geinteresseerden
[url]http://www.slideshare.net/gavingiovanno ... e-may-2013[/url]
Veiligheid van Tysabri
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Marsei
Update juni
Update juni
[URL="http://www.mstopjobandfriends.net/?p=2276"][U]Update juni[/U][/URL]
[QUOTE]22 juni 2013 Tysabri-PML update; 13 nieuwe PML gevallen en twee patiënten overleden. Wereldwijd zijn er nu 372 PML gevallen gemeld en 85 MS-patiënten aan Tysabri gerelateerd PML overleden.
Er is verder niet veel nieuws te melden, behalve dat Prof. Giovannoni zijn presentatie vereenvoudigd heeft. Onder andere Biogen, de producent van Tysabri, had hier op aangedrongen omdat de ‘overvloed’ aan informatie niet goed zou zijn of begrepen zou worden door de patiënten. Na zijn lezers hun mening gevraagd te hebben heeft hij inderdaad een kortere versie op zijn blog gezet (zie hieronder).[/QUOTE]
[URL="http://www.mstopjobandfriends.net/?p=2276"][U]Update juni[/U][/URL]
[QUOTE]22 juni 2013 Tysabri-PML update; 13 nieuwe PML gevallen en twee patiënten overleden. Wereldwijd zijn er nu 372 PML gevallen gemeld en 85 MS-patiënten aan Tysabri gerelateerd PML overleden.
Er is verder niet veel nieuws te melden, behalve dat Prof. Giovannoni zijn presentatie vereenvoudigd heeft. Onder andere Biogen, de producent van Tysabri, had hier op aangedrongen omdat de ‘overvloed’ aan informatie niet goed zou zijn of begrepen zou worden door de patiënten. Na zijn lezers hun mening gevraagd te hebben heeft hij inderdaad een kortere versie op zijn blog gezet (zie hieronder).[/QUOTE]
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Blauwvlinderke
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Robbie
Updates
Updates
[url]https://www.facebook.com/notes/ccsvi-in ... 1616067211[/url]
[url]http://www.ehealthme.com/ds/tysabri/death[/url]
[QUOTE]"Please read the recent comments on this note--Lisa posted to tell us about her change from JC- to JC+ and her rebound experience after Tysabri, as well as her friend's death due to PML. We need to share this information in our community. These are not scare tactics--this is an effort to save lives. Be well." [url]https://www.facebook.com/permalink.php? ... 0796282297[/url][/QUOTE]
[url]https://www.facebook.com/notes/ccsvi-in ... 1616067211[/url]
[url]http://www.ehealthme.com/ds/tysabri/death[/url]
[QUOTE]"Please read the recent comments on this note--Lisa posted to tell us about her change from JC- to JC+ and her rebound experience after Tysabri, as well as her friend's death due to PML. We need to share this information in our community. These are not scare tactics--this is an effort to save lives. Be well." [url]https://www.facebook.com/permalink.php? ... 0796282297[/url][/QUOTE]
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Robbie
[URL]http://www.jwatch.org/na31800/2013/08/0 ... oc_jwneuro[/URL]
[quote]A case of cerebellar granule cell neuronopathy with progressive ataxia and cerebellar atrophy in the setting of natalizumab treatment for multiple sclerosis
Progressive multifocal leukoencephalopathy is the protypical presentation of JC virus cerebral infection, and it is always associated with T2 lesions on magnetic resonance imaging (NEJM JW Neurol April 8 2013).
A cerebellar degeneration syndrome has been described in the setting of HIV that may be due to a genetic variation in the JC virus.
This case report describes a patient with multiple sclerosis (MS) who, after being treated with natalizumab for more than 4 years, developed progressive gait ataxia and appendicular signs over 4 months. MRI did not show any new T2 or gadolinium-enhancing lesions but did demonstrate cerebellar atrophy.
Cerebrospinal fluid (CSF) was positive for JC virus by PCR testing, natalizumab was stopped, and plasma exchange promptly removed circulating natalizumab. The patient continued to worsen over 2 months, prompting a cerebellar biopsy establishing severe destruction of the granule cells in the cortical structure, with immunohistochemistry detecting JC virus within the nucleus of remaining granule cells.[/quote]
[quote][B]Comment[/B]
Clinicians prescribing natalizumab for MS patients who are JC virus serum antibody–positive need to know about this progressive ataxia with cerebellar atrophy syndrome. Because MS also causes ataxia, the syndrome may be underappreciated and erroneously attributed to MS progression. Instead, CSF should be obtained, and if it is positive for JC virus, natalizumab should be withdrawn and plasma exchange initiated. Treatment beyond that is supportive, with the hope that the immune reconstitution will limit ongoing granule cell damage.[/quote]
[quote]A case of cerebellar granule cell neuronopathy with progressive ataxia and cerebellar atrophy in the setting of natalizumab treatment for multiple sclerosis
Progressive multifocal leukoencephalopathy is the protypical presentation of JC virus cerebral infection, and it is always associated with T2 lesions on magnetic resonance imaging (NEJM JW Neurol April 8 2013).
A cerebellar degeneration syndrome has been described in the setting of HIV that may be due to a genetic variation in the JC virus.
This case report describes a patient with multiple sclerosis (MS) who, after being treated with natalizumab for more than 4 years, developed progressive gait ataxia and appendicular signs over 4 months. MRI did not show any new T2 or gadolinium-enhancing lesions but did demonstrate cerebellar atrophy.
Cerebrospinal fluid (CSF) was positive for JC virus by PCR testing, natalizumab was stopped, and plasma exchange promptly removed circulating natalizumab. The patient continued to worsen over 2 months, prompting a cerebellar biopsy establishing severe destruction of the granule cells in the cortical structure, with immunohistochemistry detecting JC virus within the nucleus of remaining granule cells.[/quote]
[quote][B]Comment[/B]
Clinicians prescribing natalizumab for MS patients who are JC virus serum antibody–positive need to know about this progressive ataxia with cerebellar atrophy syndrome. Because MS also causes ataxia, the syndrome may be underappreciated and erroneously attributed to MS progression. Instead, CSF should be obtained, and if it is positive for JC virus, natalizumab should be withdrawn and plasma exchange initiated. Treatment beyond that is supportive, with the hope that the immune reconstitution will limit ongoing granule cell damage.[/quote]
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Robbie
Risk factors for rare diseases can be risky to define: PML and natalizumab.
Risk factors for rare diseases can be risky to define: PML and natalizumab.
[url]http://www.ncbi.nlm.nih.gov/pubmed/23925759[/url]
[QUOTE]When rare neurologic diseases become topics of editorials in journals such as Nature Neuroscience,1 the New England Journal of Medicine,2 and Neurology®,3 there is usually something more of general interest than the rare disease itself. Such is the case for progressive multifocal leukoencephalopathy (PML), the JC virus-induced demyelinating disease that was once relegated for discussion to the back of the textbook, whether in microbiology or neurology. Not any longer. Incidence and publication of cases of PML have risen more than 50-fold within the last decade. Renewed recognition of PML started in the mid-1980s, when it was recognized as an AIDS-defining illness in 1%-3% of all HIV-1-infected persons, still true in the era of combined antiretroviral therapy.4 PML is reported in patients with underlying neoplastic diseases, organ transplants, and rheumatic diseases, but by 2004, PML dramatically entered the mainstream as a serious adverse event associated with a promising monoclonal antibody therapy, natalizumab, for treatment of relapsing-remitting multiple sclerosis (MS). Nature itself showed that demyelinating diseases of substantially different etiologies and pathologies can occur in the same brain, and remarkably enough in some cases, not with a fatal outcome. In 2006, the estimated occurrence of PML in natalizumab-treated patients with MS, with an average treatment of 17 months, was 1 per 1,000.5 With more than 115,000 patients globally treated with natalizumab for longer periods of time, that estimate is 1 per 330.6 In patients who test positive for antibodies to JCV, have a clinical history of immune suppressive treatment before natalizumab, and have received more than 24 doses, the number of PML cases is 1 per 90.[/QUOTE]
[url]http://www.ncbi.nlm.nih.gov/pubmed/23925759[/url]
[QUOTE]When rare neurologic diseases become topics of editorials in journals such as Nature Neuroscience,1 the New England Journal of Medicine,2 and Neurology®,3 there is usually something more of general interest than the rare disease itself. Such is the case for progressive multifocal leukoencephalopathy (PML), the JC virus-induced demyelinating disease that was once relegated for discussion to the back of the textbook, whether in microbiology or neurology. Not any longer. Incidence and publication of cases of PML have risen more than 50-fold within the last decade. Renewed recognition of PML started in the mid-1980s, when it was recognized as an AIDS-defining illness in 1%-3% of all HIV-1-infected persons, still true in the era of combined antiretroviral therapy.4 PML is reported in patients with underlying neoplastic diseases, organ transplants, and rheumatic diseases, but by 2004, PML dramatically entered the mainstream as a serious adverse event associated with a promising monoclonal antibody therapy, natalizumab, for treatment of relapsing-remitting multiple sclerosis (MS). Nature itself showed that demyelinating diseases of substantially different etiologies and pathologies can occur in the same brain, and remarkably enough in some cases, not with a fatal outcome. In 2006, the estimated occurrence of PML in natalizumab-treated patients with MS, with an average treatment of 17 months, was 1 per 1,000.5 With more than 115,000 patients globally treated with natalizumab for longer periods of time, that estimate is 1 per 330.6 In patients who test positive for antibodies to JCV, have a clinical history of immune suppressive treatment before natalizumab, and have received more than 24 doses, the number of PML cases is 1 per 90.[/QUOTE]
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Marsei
With longer follow-up: even more toxic than suspected.
With longer follow-up: even more toxic than suspected.
[URL="http://www.ncbi.nlm.nih.gov/pubmed/25897454"][U]Natalizumab (TYSABRI)[/U][/URL] and multiple sclerosis. With longer follow-up: even more toxic than suspected.
[QUOTE]The standard disease-modifying treatment for patients with relapsing-remitting multiple sclerosis is interferon beta injection, in the absence of a better alternative.
In 2007, natalizumab had an unfavourable harm-benefit balance in patients with severe multiple sclerosis in whom interferon beta was ineffective, due to insufficient evidence of efficacy and a risk of life-threatening progressive multifocal leukoencephalopathy.
In 2014, we found no new comparative trials focusing on the efficacy of natalizumab monotherapy in its authorised indications in the EU.
Post-marketing data confirm the adverse effects identified in clinical trials, including serious and life-threatening opportunistic infections, particularly progressive multifocal leukoencephalopathy in about two per thousand treated patients (an incidence twice as high as initially estimated), and potentially severe hypersensitivity reactions. An increased risk of cancer in the long term cannot be ruled out. Post-marketing data also show that natalizumab can cause severe liver damage.
In addition, natalizumab withdrawal because of progressive multifocal leukoencephalopathy almost always triggers an immune reconsti- tution syndrome that can lead to neurological complications or even death.
In practice, regardless of the severity of multiple sclerosis, it does not seem reasonable to expose patients to the many serious adverse effects of natalizumab for such an uncertain benefit.[/QUOTE]
[URL="http://www.ncbi.nlm.nih.gov/pubmed/25897454"][U]Natalizumab (TYSABRI)[/U][/URL] and multiple sclerosis. With longer follow-up: even more toxic than suspected.
[QUOTE]The standard disease-modifying treatment for patients with relapsing-remitting multiple sclerosis is interferon beta injection, in the absence of a better alternative.
In 2007, natalizumab had an unfavourable harm-benefit balance in patients with severe multiple sclerosis in whom interferon beta was ineffective, due to insufficient evidence of efficacy and a risk of life-threatening progressive multifocal leukoencephalopathy.
In 2014, we found no new comparative trials focusing on the efficacy of natalizumab monotherapy in its authorised indications in the EU.
Post-marketing data confirm the adverse effects identified in clinical trials, including serious and life-threatening opportunistic infections, particularly progressive multifocal leukoencephalopathy in about two per thousand treated patients (an incidence twice as high as initially estimated), and potentially severe hypersensitivity reactions. An increased risk of cancer in the long term cannot be ruled out. Post-marketing data also show that natalizumab can cause severe liver damage.
In addition, natalizumab withdrawal because of progressive multifocal leukoencephalopathy almost always triggers an immune reconsti- tution syndrome that can lead to neurological complications or even death.
In practice, regardless of the severity of multiple sclerosis, it does not seem reasonable to expose patients to the many serious adverse effects of natalizumab for such an uncertain benefit.[/QUOTE]
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Marsei
Rechtszaak
Rechtszaak
Biogen Idec, Elan facing [URL="http://www.bostonglobe.com/business/201 ... nt=event25"][U]suits[/U][/URL] over MS drug side effects
Biogen Idec, Elan facing [URL="http://www.bostonglobe.com/business/201 ... nt=event25"][U]suits[/U][/URL] over MS drug side effects
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Marsei
Positieve onderzoeksresultaten bij tysabri 1x in de 2 maanden
Positieve onderzoeksresultaten bij tysabri 1x in de 2 maanden
Study Into Extended Tysabri Dosage Suggests [URL="http://overcomingms.org/news-research/o ... -efficacy/"][U]PML Risk Could Be Reduced[/U][/URL] Without Affecting Drug’s Efficacy
[QUOTE][B]An ongoing study into the use of Tysabri in Multiple Sclerosis patients has revealed early results which suggest that the recommended dosage interval could be doubled from every four weeks to every eight, without any negative effect on the efficacy of the treatment. And critically, reducing the overall exposure to the drug potentially reduces the risk of developing PML, even in those patients with a higher-than-average PML risk.[/B]
[/QUOTE]
[QUOTE]Of roughly 2000 patients participating in the study, half received Tysabri according to the label recommendation of every 28 days, and the other half were given the drug at intervals ranging from 31 to 61 days. [B]The initial results showed a similar, or better, efficacy of the drug in those on the extended dosing interval with no cases of PML recorded at all, compared to four cases amongst those on the 28-day schedule.[/B][/QUOTE]
[QUOTE]Lana Zhovtis-Ryerson, MD, of NYU Langone Medical Center in New York City, who presented these findings at ECTRIMS in Barcelona last week, highlighted however that [B]the data is currently insufficient to fully support the findings on PML risk at this stage, and that it could take 18 months (in order to accrue the correct number of patient-years of exposure in both groups) before the differences can be definitely defined.[/B] But this is potentially great news for people currently taking Tysabri, and may make Tysabri a much safer treatment option for people with very active MS.[/QUOTE]
Study Into Extended Tysabri Dosage Suggests [URL="http://overcomingms.org/news-research/o ... -efficacy/"][U]PML Risk Could Be Reduced[/U][/URL] Without Affecting Drug’s Efficacy
[QUOTE][B]An ongoing study into the use of Tysabri in Multiple Sclerosis patients has revealed early results which suggest that the recommended dosage interval could be doubled from every four weeks to every eight, without any negative effect on the efficacy of the treatment. And critically, reducing the overall exposure to the drug potentially reduces the risk of developing PML, even in those patients with a higher-than-average PML risk.[/B]
[/QUOTE]
[QUOTE]Of roughly 2000 patients participating in the study, half received Tysabri according to the label recommendation of every 28 days, and the other half were given the drug at intervals ranging from 31 to 61 days. [B]The initial results showed a similar, or better, efficacy of the drug in those on the extended dosing interval with no cases of PML recorded at all, compared to four cases amongst those on the 28-day schedule.[/B][/QUOTE]
[QUOTE]Lana Zhovtis-Ryerson, MD, of NYU Langone Medical Center in New York City, who presented these findings at ECTRIMS in Barcelona last week, highlighted however that [B]the data is currently insufficient to fully support the findings on PML risk at this stage, and that it could take 18 months (in order to accrue the correct number of patient-years of exposure in both groups) before the differences can be definitely defined.[/B] But this is potentially great news for people currently taking Tysabri, and may make Tysabri a much safer treatment option for people with very active MS.[/QUOTE]
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Marsei
Disappointing Results Announced from Clinical Trial of Tysabri (Natalizumab) in SP MS
Disappointing Results Announced from Clinical Trial of Tysabri (Natalizumab) in SP MS
Disappointing Results Announced from Clinical Trial of Tysabri (Natalizumab) in [URL="http://www.nationalmssociety.org/About- ... nical-Tria"][U]Secondary-Progressive MS[/U][/URL]
[QUOTE][B]Summary[/B]
• A phase III clinical trial of Tysabri® (natalizumab, Biogen) compared with placebo in 889 people with secondary-progressive MS did not meet its primary endpoint, meaning that Tysabri was not shown to slow progression using a combined measure of disability.
[/QUOTE]
Disappointing Results Announced from Clinical Trial of Tysabri (Natalizumab) in [URL="http://www.nationalmssociety.org/About- ... nical-Tria"][U]Secondary-Progressive MS[/U][/URL]
[QUOTE][B]Summary[/B]
• A phase III clinical trial of Tysabri® (natalizumab, Biogen) compared with placebo in 889 people with secondary-progressive MS did not meet its primary endpoint, meaning that Tysabri was not shown to slow progression using a combined measure of disability.
[/QUOTE]