Ask your neurologist for PML!!! - FUMADERM (BG12) NOW available for German people with MS!

There have been already 4 promising cases of PML reported on FUMARDEM (BfArM's ADR Database (10130944)) in people with psoriasis on this drug and now people with Multiple Sclerosis can get the same!!!

GRAB IT guys! but always remember: If it’s not FURMADERM it’s not FURMADERM! ...or TYSABRI ...or GILENYA ...or...

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Fumaric acid-associated progressive multifocal leukencephalopathy (PML), treatment and survival in a patient with psoriasis
U. Ermis, M. Wiesmann, K. Nolte, A. Chan, O. Adams, J. Weis, J.B. Schulz (Aachen, Bochum, Düsseldorf)

Background: Fumaric acid and/or its derivates were found to be effective and safe in the treatment of psoriasis vulgaris. In addition, treatment with fumaric acid is currently evaluated in phase II/III trials for the therapy of multiple sclerosis.
PML is a rare but frequently fatal disease caused by the uncontrolled replication of JC virus (JCV), a polyomavirus, in the brains of some immunocompromised individuals, including 4 to 5% of HIV-positive patients with AIDS, also occurring in association with leukemia and lymphoma.

Clinical case: We describe a 74-year-old male with psoriasis who developed subacute neurologic symptoms after 3 years of monotherapy with fumaric acid. The patient had a history of psoriasis for more than 5 years and he was treated with different immunosuppressive and immunomodulatory therapies including corticosteroids, a second generation retinoid, and methotrexate.

Results: MRI scan demonstrated a subcortical area of T2-hyperintensity within the white matter of the left temporal lobe, without gadolinium enhancement. PML was confirmed by brain biopsy and positive JC virus-PCR in the brain biopsy and cerebrospinal fluid (CSF). Discontinuation of fumaric acid resulted in an induction of an immune reconstitution inflammatory syndrome (IRIS) with gadolinium enhancement after five weeks. The patient was treated with mefloquine and mirtazapine. At 5 months there was improvement of neurological symptoms, regression of MRI lesions and JC virus load in the CSF was below detection limit.

Conclusions: This is the first report of PML associated with the small molecule fumaric acid, a therapy that in contrast to other modern immune therapies that may cause PML like rituximab, natalizumab, efalizumab, and infliximab does not belong to the group of monoclonal antibodies. JC virus associated PML occurs in patients with an immunosuppressive syndrome, e.g. lymphoma or HIV infection and in most cases inevitably leads to death of the patients. Four patients treated with Efalizumab for psoriasis reportedly developed PML, all of them died within short duration of the disease. Lately several multiple sclerosis patients who had been treated with natalizumab developed a PML and survived the disease after cessation of the immunosuppressive treatment. With this present case, we describe for the first time fumaric acid-associated PML and IRIS in a patient with psoriasis and the successful clinical management.

source: http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=134972&XNSPRACHE_ID=1&XNKONGRESS_ID=143&XNMASKEN_ID=900