Wed, Aug 27, 2014, 2:12 PM EDT - U.S. Markets close in 1 hr 48 mins

Recent

% | $
Quotes you view appear here for quick access.

Biogen Idec Inc. Message Board

  • creebril creebril Mar 1, 2005 5:04 PM Flag

    12th of feb first patient hospitalized

    Kinda says biib knew what was going on.
    patient-1

    Case 1: Confirmed

    The following information is based on reports from the treating neurologist.

    A 46-year-old female MS subject with a past medical history of depression and migraines received 37 doses of TYSABRI in combination with AVONEX as part of company-sponsored clinical trials. Her last dose of TYSABRI was on 18 Jan 05.

    In Dec 04, the subject experienced right-sided weakness and aphasia, which was initially considered a MS relapse. A MRI revealed a left-sided 2 cm non-enhancing tumor like lesion. She was treated with two courses of steroids, one dose in Dec 04 and the other in Jan 05. Her symptoms continued to worsen with altered mental status and increased spasticity. She was hospitalized on 12 Feb 05. Neurological examination showed a non-responsive subject with right gaze preference, decorticate posturing, upgoing toes and no gag reflex.

    A MRI showed �deep white matter, small vessel ischemic changes within the centrum semiovale periventricular regions, high signal throughout portions of the left temporal and left parietal lobes extending across the corpus callosum into the right frontal lobe.� This MRI appearance suggested a differential diagnosis that included PML.

    Complete blood count was significant for a WBC of 14,000 and 29,000 cells/�L on 12 February and 15 February 2005, respectively (normal range 3,500-10,600 cells/�l). A lumbar puncture revealed glucose of 53 mg/dL (normal range 15-45) and protein of 90 mg/dL (normal range 40-70). Viral PCR testing of the cerebral spinal fluid (CSF) was positive for JC virus. HIV testing via Elisa was negative.

    The subject was treated with intravenous methylprednisolone but her condition continued to decline and she was transferred to a hospice. The subject died on 24 February 2005. AVONEX neutralizing antibody status and TYSABRI antibody status were negative at baseline and weeks 24, 48 and 72.

    Concomitant medications at the time of the event included vitamins, ranitidine, donepezil, tizanidine, zolpidem, and ibuprofen.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Just wanted to know your thoughts on eln, and biib right now. i had 7000 shares of eln, but sold in january. only got caught with 1000 shares. i was holding 2500 shares of biib and took the hit. i believe strongly in both companies, do you think they can both come back. biib seems alot stronger. im hoping for eln to go back up in the lower teens to recoup. just wanted to pick your brain. thanks a-z

    • > Good post duke, would you let a stockbroker (K.Martin)run a biotech company? <

      Not really. Although science folks are not known for charisma, if I could find such a qualified person they would get the job before a stockbroker!

      HS

    • Right here seemed credible Don't know ? scroll down.

      h**p://www.thisisms.com/modules.php?name=Forums&file=viewtopic&t=932&postdays=0&postorder=asc&start=30

    • BIIB did not mention that the patient was on prednisone - that changes the whole ballgame because steroid treatment can cause PML to flare

      more references of steroid treatment causing PML

      Olindo S, Guillon B, Faighel M, Feve JR.
      Related Articles, Links

      [Progressive multifocal leukoencephalopathy and pulmonary sarcoidosis]
      Rev Neurol (Paris). 2000 Nov;156(11):1013-6. French.
      PMID: 11119054 [PubMed - indexed for MEDLINE]

      Arbusow V, Strupp M, Samtleben W, Hatz H, Bruckmann H, Brandt T.
      Related Articles, Links

      [Progressive multifocal leukoencephalopathy as a result of immunosuppressive therapy]
      Dtsch Med Wochenschr. 1999 May 28;124(21):653-6. German.
      PMID: 10382545 [PubMed - indexed for MEDLINE]

      Clin Exp Nephrol. 2003 Mar;7(1):63-6.
      Related Articles, Links


      Acute posterior leukoencephalopathy in a patient with nephrotic syndrome.

      Utsumi K, Amemiya S, Iizuka M, Iino Y, Katayama Y.

      The Second Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan. utsumi@nms.ac.jp

      Reversible posterior leukoencephalopathy syndrome is one of the most serious complications of immunosuppressive therapy. The clinical features include headache, altered mental functioning, seizures, cortical blindness and other visual disturbances, with hypertension. The neuroimaging studies reveal predominant posterior leukoencephalopathy. Usually, antihypertensive therapy and reduction or withdrawal of immunosuppressive agents have been reported to resolve the neurological deficits and imaging abnormalities within a few weeks. We discuss here a 51-year-old woman with nephrotic syndrome who developed acute leukoencephalopathy during combination therapy with prednisolone and cyclosporine. She developed severe headache, visual disturbance, consciousness disturbance, and generalized tonic clonic convulsion. A computed tomography scan (CT) revealed low-density areas in the subcortices of the parietal and occipital lobes. Magnetic resonance imaging (MRI) disclosed a high signal intensity area on T2-weighted images and a low signal intensity area on T1-weighted images in the same lesions. Follow-up brain CT and MRI were performed several times. Three weeks after the first study, these lesions had completely resolved, but she had persistent altered consciousness for more than 1 year.

      Am J Kidney Dis. 2001 Apr;37(4):E30.
      Related Articles, Links


      Reversible posterior leukoencephalopathy in a patient with minimal-change nephrotic syndrome.

      Ikeda M, Ito S, Hataya H, Honda M, Anbo K.

      Division of Pediatric Nephrology, Tokyo Metropolitan Kiyose Children's Hospital, Japan. m.ikeda@chp.kiyose.tokyo.jp

      A 9-year-old boy with nephrotic syndrome was transferred to our hospital because of acute renal failure and disturbance of consciousness after high-dose methylprednisolone therapy. He developed severe headache, visual disturbance, and generalized seizures. Brain computed tomography (CT) scan revealed multiple, bilateral, low-density areas in the parieto-occipital lobes. Magnetic resonance imaging (MRI) disclosed a high signal intensity area on T2-weighted images and a low signal intensity area on T1-weighted images in the same lesion. Follow-up brain CT scan and MRI, 2 weeks after the first studies, showed complete resolution of the abnormal lesions, which suggested the diagnosis of reversible posterior leukoencephalopathy syndrome (RPLS). Hypertension and high-dose methylprednisolone administration to the patient in the nephrotic state may be causes of this uncommon syndrome in this case. This is the first report of RPLS in nephrotic syndrome with hypertension not associated with cyclosporine administration.

      • 3 Replies to pinvestment
      • Thank you for sharing your homework on this matter. I find comfort in knowing extra bits of information. I have confidence that Biogen will get through this Regulatory issue.

        Do we know for sure that patient 1 was on prednisone. I know he was also getting Avonex. Who knows what other drugs the poor patient was getting. How do you untangle this mess.

      • Pinvestment,

        Thanks for providing a lot of medical information related to this drugs. I bought yesterday because I though it was overreacted for quick profit but I have been reading your posts and now I want to hold for the long term.

        You must be someone who is in the medical field.

      • this is very important since the earlier post today said the patient had received two month long treatments of prednisone - prednisone is an immunosuppressant and has been linked to the development of PML

        more references

        Dtsch Med Wochenschr. 1999 May 28;124(21):653-6.
        Related Articles, Links


        [Progressive multifocal leukoencephalopathy as a result of immunosuppressive therapy]

        [Article in German]

        Arbusow V, Strupp M, Samtleben W, Hatz H, Bruckmann H, Brandt T.
        HISTORY AND ADMISSION FINDINGS: A 62-year-old woman developed paresis in her right arm within several weeks. She was being treated with methylprednisolone (4 mg daily) and chlorambucil (2 mg every other day) for systemic lupus erythematodes (SLE), which was now in remission. Neurological examination on admission revealed a right flaccid hemiparesis, predominantly of the right arm. The physical examination was otherwise unremarkable. INVESTIGATIONS: Magnetic resonance imaging (MRI) (T2 weighted) showed hyperintense changes in the subcortical medullary layer of the left precentral gyrus without perifocal oedema or abnormal contrast medium uptake, which argued against progressive cerebral ischaemia or tumour. Blood and cerebrospinal fluid (CSF) showed no abnormalities except leukopenia and a raised antinuclear antibody titre. Progressive paralysis of the right side of the body after 2 years of immunosuppressive treatment, the MRI findings and an essentially normal CSE suggested progressive multifocal leucoencephalopathy (PML), confirmed by polymerase chain reaction (PCR) demonstrating JC-virus DNA in serum and CSF. TREATMENT AND COURSE: As a result of the CNS infection with papovavirus JC, an opportunistic infection of the central nervous system, which is usually fatal, occurred. The cerebral changes spread within a few weeks, despite of the immunosuppressive drugs having been discontinued. The pareses progressed further and a marked personality disorder of organic origin ensued. CONCLUSION: While efficacious immunosuppressive drugs against autoimmune disease are available, their use risks the occurrence of life-threatening opportunistic infections.

        Pediatr Nephrol. 2004 Apr;19(4):442-4. Epub 2003 Dec 16.
        Related Articles, Links


        Reversible posterior leukoencephalopathy in a patient with Wegener granulomatosis.

        Ohta T, Sakano T, Shiotsu M, Furue T, Ohtani H, Kinoshita Y, Mizoue T, Kiya K, Tanaka I.

        Department of Pediatrics, Hiroshima Prefectural Hospital, Hiroshima, Japan. ohtaotachan1@aol.com

        A 14-year-old girl with rapidly progressive glomerulonephritis was transferred to our hospital because of acute renal failure. A diagnosis of Wegener granulomatosis was made according to the symptom triad of a renal biopsy demonstrating crescentic glomerulonephritis, severe sinusitis, and serological findings of raised proteinase 3 anti-neutrophil cytoplasmic antibody level. In spite of combination therapy with methylprednisolone, cyclophosphamide, and plasma exchange, her renal function gradually deteriorated. Thereafter, she suffered a severe headache and generalized seizures. Brain computed tomography (CT) scan revealed bilateral low-density areas in the parieto-occipital lobes. Magnetic resonance imaging (MRI) disclosed a high-intensity area on T2-weighted images and a low-signal intensity area on T1-weighted images in the same lesion. Follow-up brain CT scan 3 weeks and MRI 2 months after the first studies showed complete resolution of the abnormal lesions, which indicated reversible posterior leukoencephalopathy syndrome. In addition to renal failure, hypertension, and cyclophoshamide, the primary disease may have played a role in the development of this uncommon syndrome in our patient.

        seems like heavy steroid pre-treatment could have resulted in this case of PML - or maybe it is a combination of methylprednisolone and tysabri with beta interferon

    • if the history that was described about an hour and a half ago is correct then there are severe mitigating circumstances since the patient was just coming off of two courses of prednisone treatment - PREDNISONE TREATMENT CAN CAUSE PML -

      here are a few references that link steroid treatment with the development of PML
      111111111111111111111111111111111111111111111
      J Rheumatol. 1995 Aug;22(8):1593-5.
      Related Articles, Links


      Progressive multifocal leukoencephalopathy complicating treatment for Wegener's granulomatosis.

      Morgenstern LB, Pardo CA.

      Department of Neurology, Johns Hopkins Hospital, Baltimore, MD, USA.

      We describe a man treated with cyclophosphamide and prednisone for Wegener's granulomatosis who developed biopsy proven progressive multifocal leukoencephalopathy (PML). Upon discontinuation of immunosuppression he made a dramatic recovery. As immunosuppressant use is increasing we draw attention to this potentially fatal, but reversible neurologic disease.
      22222222222222222222222222222222222222222222
      Chest. 1983 Mar;83(3):572-5.
      Related Articles, Links


      The association of progressive multifocal leukoencephalopathy and sarcoidosis.

      Rosenbloom MA, Uphoff DF.

      A 59-year-old woman had a right homonymous hemianopsia, memory impairment for five months, a nonenhancing area in the left parieto-occipital region on CT scan, and bilateral reticulonodular infiltrates on chest x-ray film. Lung biopsy findings were consistent with sarcoidosis, a clinical diagnosis of CNS sarcoidosis made, and prednisone therapy begun. She deteriorated neurologically and died. At autopsy characteristic histologic and electron microscopic features of progressive multifocal leukoencephalopathy (PML) were found. We conclude that this and other cases demonstrate an association of PML and sarcoidosis and that steroid treatment is not a precondition. We also suggest an aggressive diagnostic approach in evaluating sarcoidosis with atypical neurologic deficits.

      THE OTHER INTERESTING POINT IS THAT IT SEEMS LIKE THE PATIENT WAS NOT TREATED CORRECTLY - IF THE PML DIAGNOSES WAS MADE THE PROPER TREATMENT WOULD HAVE BEEN TO REVERSE IMMUNOSUPPRESSION - SO IT SEEMS PLAUSIBLE THAT MIS-DIAGNOSIS OF PML AND MIS-TREATMENT MAY HAVE BEEN THE CAUSE OF THE PATIENT'S DEMISE

    • Concomitant medications at the time of the event included vitamins, ranitidine, donepezil, tizanidine, zolpidem, and ibuprofen.

 
BIIB
342.96-0.03(-0.01%)2:10 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.