Testing for treatment with ‘Rituximab’

    • Anonymous
      September 10, 2011 at 10:05 pm

      Hey everybody. I’m Edvaldo, and I also have CIDP. I’ve been talking to my doctor about the treatment with Rituximab, and he told me that considering the possible complications with JC virus, I should take a exam named STRATIFY-JCV. Does anybody know something about this exam, or where can I found it? Please, I really need this information. If anybody knows, contact me. Thanks. Edvaldo.

    • Anonymous
      September 11, 2011 at 11:02 am

      The information is readily available on line. For example, from the manufacturer’s website:

      “…The detection of anti-JCV antibodies may provide a means to segment, or stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI(R) (natalizumab) and assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but serious, brain infection…”

      From the NIH: “…The detection of anti-JCV antibodies may provide a means to segment, or stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI(R) (natalizumab) and assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but serious, brain infection…”

      “…Rituximab, sold under the trade names Rituxan and MabThera, is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells. Rituximab is used in the treatment of many lymphomas, leukemias, transplant rejection and some autoimmune disorders….”

      “…Natalizumab is a humanized monoclonal antibody against the cellular adhesion molecule α4-integrin. Natalizumab is used in the treatment of multiple sclerosis and Crohn’s disease. It is co-marketed by Biogen Idec and Élan as Tysabri, and was previously named Antegren. Natalizumab is administered by intravenous infusion every 28 days..”

      Apparently there is a connection to the drugs ending in ‘mab.’

      From the FDA website:

      [I]”…Rituxan (rituximab) – PML
      Audience: Rheumatological healthcare professionals

      [Posted 10/23/2009] Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.

      Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated..[/I]..”

      Yet another bit of data from Medscape [I]”…September 11, 2008 — The safety labeling for rituximab intravenous infusion (Rituxan, Genentech, Inc, comarketed with Biogen Idec, Inc) has been updated to reflect a fatal case of progressive multifocal leukoencephalopathy (PML) in a rheumatoid arthritis (RA) patient, the US Food and Drug Administration (FDA) announced today..[/I].”

      This info from Wikipedia seems relevant: [I]”…The virus is very common in the general population, infecting 70 to 90 percent of humans;…Immunodeficiency or immunosuppression allows JCV to reactivate. In the brain it causes the usually fatal progressive multifocal leukoencephalopathy, or PML, by destroying oligodendrocytes. Whether this represents the reactivation of JCV within the CNS or seeding of newly reactivated JCV via blood or lymphatics is unknown.[10] Several studies since 2000 have suggested that the virus is also linked to colorectal cancer, as JCV has been found in malignant colon tumors, but these findings are still controversial.[11][/I]…”

      I found the most useful information here: [url]http://ms.about.com/od/treatments/a/How-Is-Pml-Diagnosed.htm[/url]

      For example, [I]”…However, if the test is positive for the JC virus, that does not automatically confer a diagnosis of PML. The problem here is that a very large number of people in the general population will have these antibodies -– some estimate up to 70%…”[/I]

      The key, for me, is that if your symptoms begin to noticeably worsen, notify your doctor immediately. The medicine should be stopped and other therapy methods discussed.

    • Anonymous
      September 11, 2011 at 3:01 pm

      “…Biogen Selects Unilabs To Provide STRATIFY- JCV Test
      Announced Date : Jul 06 2011

      Unilabs A.S. announced that Biogen Idec Inc. (Biogen) selected the company to provide a companion diagnostic anti-JCV antibody assay test, called STRATIFY-JCV. The test is a highly sensitive two-step ELISA assay used to detect anti-JCV antibodies. The presence of anti-JCV antibodies is one in a three-factor risk stratification algorithm, along with prior immunosuppressant use and treatment duration, used to calculate the risk of TYSABRI-treated patients developing progressive multifocal leukoencephalopathy (PML)….”

      from: [url]http://www.researchviews.com/healthcare/medical/invitrodiagnostics/NewsReport.aspx?sector=In%20Vitro%20Diagnostics&ArticleID=P18020[/url]

      You should work closely with your doctor to decide which tests are useful.

      The Stratify process would seem to include three factors.

      1. Presence of jcv.

      2. Prior immunosuppresant use.

      3. Treatment Duration.

      Best of Luck to you (and anybody on Rituximab….)

    • Anonymous
      September 11, 2011 at 3:09 pm

      I’ve been recently with my doctor and he told me about the risks with the treatment with Rituximab and he said that in the future will have the exam to detect the JVC virus here in Brazil. But I’ve noticed that pacients with MS have been take this exam in some countries in Europe. I though that I should take this exam so I could treat with Rituximab in the future, ’cause in the present day my treatment is with Immunoglobulin, every 15 days, 30g for aplication. But there’s a big problem with the Health Insurance and the hospitals. I know that there’s a lot of risks with the tysabri in the pacients with MS, and my doctor also alerted me to the same risks (PML) using Rituximab for the pacients with CIDP. That’s why I’m really interested to do this exam. If i’m wrong about this ideas, I really would like to ask your help. ‘Cause even searching, the only thing I realized it’s that there’re people taking in US with good results.
      Thanks, Edvaldo.

    • Anonymous
      September 11, 2011 at 3:23 pm

      I’ve seen this websites before and this informations, but the risk is commum in both diseases regardless of which drug (monoclonal antibody) to be used. The risks are due to the JC virus that will take this identifier. That’s all I could understand from my research and consulting the doctor. Considering that today I apply immunoglobulin, 30g every 15 days, now the results are not as good and there are many problems with health insurance and hospitals here. Don’t you think it’s a good idea to get tested? I’m really worried about this, and there’s nothing safe to be done anyway. I really would like ur opinion about this.
      Thanks, and sorry for this bad english.. 🙂

    • Anonymous
      September 11, 2011 at 6:41 pm

      I understand that English is not your primary language. If I had to communicate in Portugese could say nothing.

      No, personally, I would not get tested for either the jcv antibody or the stratify assay.

      Instead, I would closely monitor my own symptoms.

      If either myself, my family member, or any doctor noticed any new or worsening medical problems such as changes in thinking, walking, strength, vision or almost anything else that lasts several days I would notify my doctor immediately.

      The problem seems to be with patients who have other diseases and have had more than one type treatment.

      The following translation is courtesy of google translate:

      Eu entendo que o Inglês não é o seu idioma principal. Se eu tivesse de comunicar em Português poderia dizer nada.

      Não, pessoalmente, eu não iria fazer o teste tanto para o anticorpo JCV ou estratificar o ensaio.

      Em vez disso, gostaria de acompanhar de perto os meus próprios sintomas.

      Se nem eu, meu parente, ou qualquer médico notou algum problema ou agravamento médicos, tais como mudanças no pensamento, caminhando, força, visão ou qualquer outra coisa que dura vários dias que eu teria de notificar meu médico imediatamente.

      O problema parece estar com os pacientes que têm outras doenças e ter tido mais de um tipo de tratamento.

      Eu acho que muitas, muitas pessoas tomam Rituximab e não experimentar esta condição extremamente rara.

      I guess many, many people take Rituximab and do not experience this extremely rare condition.