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DIR Return to: TYSABRI (natalizumab)
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#Post#: 1495--------------------------------------------------
(Abst.) Tysabri-related PML in MS: Findings from Italian
independent registry
DIR By: agate
Date: December 22, 2016, 10:00 pm
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From PubMed, December 22, 2016:
--- Quote ---
> PLoS One. 2016 Dec 20;11(12):e0168376.
>
> Natalizumab-Related Progressive Multifocal Leukoencephalopathy
in Multiple Sclerosis: Findings from an Italian Independent
Registry.
>
> Prosperini L, de Rossi N, Scarpazza C, Moiola L, Cosottini M,
Gerevini S, Capra R; Italian PML study group.
>
> BACKGROUND:
>
> The monoclonal antibody natalizumab (NTZ) is a highly
effective treatment for patients with multiple sclerosis (MS).
However, this drug is associated with increased risk of
developing Progressive Multifocal Leukoencephalopathy (PML), an
opportunistic infection of central nervous system (CNS) caused
by the John Cunningham polyomavirus (JCV).
>
> OBJECTIVE:
>
> To describe the 12-month clinical course of 39 patients with
MS (28 women, 11 men) who developed NTZ-related PML after a mean
exposure of 39 infusions.
>
> METHODS:
>
> An Italian independent collaborative repository initiative
collected and analyzed socio-demographic, clinical, magnetic
resonance imaging (MRI) data and number of JCV-DNA copies
detected on cerebrospinal fluid (CSF) samples of patients
diagnosed as affected by NTZ-related PML.
>
> The evolution of disability, measured by the Expanded
Disability Status Scale, was assessed at NTZ start, at PML
diagnosis and after 2, 6 and 12 months from PML diagnosis. The
effect of clinical and paraclinical characteristics at PML
diagnosis on the final outcome was also investigated.
>
> RESULTS:
>
> Ten patients (25.6%) were diagnosed before 24 NTZ infusions.
In six cases (15.4%) the PML suspect was made on the basis of
highly suggestive MRI findings in absence of any detectable
change of clinical conditions (asymptomatic PML).
>
> In patients with symptomatic PML, the diagnosis was quicker
for those who presented with cognitive symptoms (n = 12) than
for those with other neurological pictures (n = 21) (p = 0.003).
Three patients (7.7%) died during the 12-month observation
period, resulting in a survival rate of 92.3%. Asymptomatic PML,
more localized brain involvement and gadolinium-enhancement
detected at MRI, as well as lower viral load were associated
with a better disability outcome (p-values<0.01).
>
> CONCLUSION:
>
> Our findings support that early PML diagnosis, limited CNS
involvement and initial signs of immune restoration are
associated with a better outcome and higher survival rate, and
confirm the utility of MRI as a surveillance tool for
NTZ-treated patients.
--- End Quote ---
The abstract can be seen here
HTML https://www.ncbi.nlm.nih.gov/pubmed/27997580.
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