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After 22 infusions, latest bloodwork showing JCV+

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    After 22 infusions, latest bloodwork showing JCV+

    Ugh. About a month ago I learned that for the second year in a row, since taking Tysabri, my MRI has shown no new lesions and smaller existing lesions. Tysabri was my first-line drug and I have had no relapses and no side-effects. This was my miracle drug. So, I got a bit upset this morning when my neuro called to say that my latest bloodwork was showing that I am JCV+.

    He said I could stay on Tysabri (I actually have infusion scheduled for tomorrow, and he basically said it wouldn't make much of a difference if I had it or not.) Or I can consider one of the Oral meds (I nixed the idea of interferons two years ago, I will not be a pin cushion.)

    I guess I'm a little stressed out because Gilenya and Tecfidera both have instances of PML as well, and they also have a lot of side-effects! And he said he did not recommend Aubagio for women in their child-bearing years as Aubagio can harm an unborn baby and can stay in your system for years. I'm 26 and not planning on having a baby any time soon, but worrying about a medication I'm taking harming a hypothetical unborn child in anyway even years after taking a drug is SO not part of the deal here, MS Gods! So that one is out.

    Anyone who's gone off Tysbari have any recommendations? Would you stay on? Obviously, in the end it will be up to me, but I just want to hear from people in similar situations.

    #2
    Did your Dr tell you what your jcv # is ?
    Since, he told you you could stay on Ty and the med is working so well for you, you might consider staying on Tysabri.
    Linda

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      #3
      He didn't but I checked online and it was 2.7 something.

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        #4
        A couple things you might consider... since Tysabri appears effective for you judging from MRI you may want to continue with it; going to another med always has unknowns... will it be effective, will I develop neutralizing antibodies and have to come off, will the side effects be significant for me, etc.

        Tecfidera has white blood cell issues, as does Gilenya, which also has cardiac issues for some people, all the MS meds have possible side effects.

        Going 5-8 weeks between infusions appears to reduce the risk of PML on Tysabri. No one (out of about 900) who have extended time (5-8 weeks) between doses has gotten PML but 4 people in the standard dosing group ( infusions every 4 weeks) have gotten PML according to study data presented at an Oct 2015 MS conference. No significant difference in disease activity was found between the two groups.

        You might consider staying on Tysabri until Ocrelizumab comes out, possibly late 2016. Trials demonstrate nearly as much effectiveness as Tysabri but far less PML risk. Plus, it appears to leave much of the immune system intact to do its work.

        Always tough decisions to make in MS! Good luck and best wishes for whatever course you decide to take. Its impossible to predict the future, often we make the best guess we can and go with it.

        You have our thoughts and care.

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          #5
          Originally posted by Myoak View Post
          You might consider staying on Tysabri until Ocrelizumab comes out, possibly late 2016. Trials demonstrate nearly as much effectiveness as Tysabri but far less PML risk. Plus, it appears to leave much of the immune system intact to do its work.
          That optimism isn't borne out by the history of ocrelizumab. The manufacturer discontinued the clinical trials for rheumatoid arthritis after "several" (no exact number can be obtained) study subjects DIED from opportunistic infections (PML is an opportunistic infection) and other adverse events. The clinical trial for lupus nephritis (kidney inflammation) was discontinued after patients developed opportunistic infections and other adverse events.

          The manufacturer abandoned any further trials in rheumatoid arthritis and lupus because it became apparent to them that those patients were NOT willing to assume the risk of death. The manufacturer redirected the research to MS specifically because they believe that MS patients ARE willing to assume the risk of death, based on the history of Tysabri. So either they're giving MS patients another opportunity for a wonderful treatment if they're willing to assume risks that patients with other autoimmune diseases aren't, or they'll be shooting desperate fish in a barrel.

          In addition, FierceBiotech reported the death of an MS patient in a clinical trial due to an adverse event. So any ideas that ocrelizumab will be low risk are not supported by reality. Tysabri looked peachy coming out of clinical trials and we all know what happened after that.

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            #6
            [QUOTE=jreagan70;1486477] FierceBiotech reported the death of an MS patient in a clinical trial due to an adverse event. So any ideas that ocrelizumab will be low risk are not supported by reality.

            The safety data appears quite good from the Phase 3 trials involving 2388 patients.

            The dosage of ocrelizumab used in Phase 3 MS trials (OPERA I and II) was 600mg. The death in the Phase 2 trial FierceBiotech referred to was, quoting Roche, “one death occurred in a patient receiving 2 x 1000mg”. Since the 600mg dose was as effective against MS as the 2,000mg dose in Phase 2 trial and there was a death at the 2,000mg dose the lower dose was used for Phase 3 trials.

            "From what we've seen so far ocrelizumab does look like a very clean drug", according to Dr. Wolinsky interviewed for a Medscape article titled, ‘Ground-Breaking’ Ocrelizumab Data Dominate ECTRIMS. That article can be Googled; I would furnish a link but it wouldn’t work unless you sign-up at Medscape which I encourage because it is an informative, respected, and safe site.

            Quoting the article, “On the overall safety data, Stephen Hauser, MD, University of California San Francisco School of Medicine, chair of the OPERA studies, noted that there are now a total of 11,000 patient-years of data on ocrelizumab, including the rheumatoid arthritis population in which it was first tested (at higher doses).

            He reported that opportunistic infections increased in the rheumatoid arthritis studies, but these have not yet been seen with the lower doses used in MS.

            Dr. Hauser believes the drug's favorable adverse effect profile is probably related to the fact that ocrelizumab interferes with the immune system in a very narrow range, specifically targeting circulating B cells expressing the CD20 antigen.

            "It doesn't affect B cells in the lymph nodes or spleen and the stem cell pool is not depleted so B cells can be repopulated. The majority of B cells in the body are unaffected, including the antibody response so patients are not immunosuppressed," he said.

            Dr. Wolinsky, however, voiced a note of caution.
            "There is a time when we should not be giddy about how good a drug looks because there might be late-emerging complications. Natalizumab also appeared very safe when it first came into the market place — it look longer to see the PML. Having said that, from what we've seen so far ocrelizumab does look like a very clean drug." End Quote.

            Again, quoting the article, “OPERA I and II were two identical studies. Each randomly assigned 828 patients with active relapsing-remitting MS to ocrelizumab, 600-mg intravenous infusion every 6 months (the first dose being given as two 300-mg infusions 15 days apart) for 2 years, or interferon β-1a, 44 μg subcutaneously three times a week.

            The primary endpoint — annualized relapse rate at 96 weeks — showed a 46% to 47% reduction with ocrelizumab.

            Both studies also showed a 40% reduction in 12- and 24-week confirmed disability progression and a 94% to 95% reduction in T1 gadolinium-enhancing lesions on MRI.
            Brain volume loss was reduced by 23.8% with ocrelizumab vs interferon,
            and the number of patients with NEDA increased from 25% with interferon β-1a to 47% with ocrelizumab.

            The most common adverse effect was infusion-related reactions, which occurred in about 28% of patients receiving ocrelizumab. Eleven patients (1.3%) withdrew because of an infusion-related reaction during the first dose.

            Serious adverse events did not differ between the ocrelizumab and interferon groups, and there were no opportunistic infections or cases of progressive multifocal leukoencephalopathy (PML).” End Quote

            It is important to know that in these two studies ocrelizumab was compared to interferon not to placebo! Interferon reduces MRI lesions by about 60% and ocrelizumab reduced MRI lesions by 94-95% additional to the reduction interferon provides. Based on those figures, I believe ocrelizumab would reduce MRI lesions by more significantly than 94-95% if compared to placebo. In other words, new MRI lesions on ocrelizumab will be occasional but rare, IMO.

            Truly, remarkable effectiveness combined with very good safety data was demonstrated in the large Phase 3 trials. Opera 1 and Opera 2 trials involved 1656 RRMS patients and the Oratorio trial using ocrelizumab in PPMS involved 732 patients, a good total number which helps establish safety and effectiveness data.

            As always, treatment discussions best involve the individual patient and clinician. What I attempt to present here is accurate information for those discussions minus the alarm, fearful emotion, or poorly supported positions which may distort clear thinking.

            All things have a place. There is a place for emotion, passion, empathy; we care for each other and feel for one another with these capacities in a world which largely doesn’t appreciate the difficulty of treatment decisions in MS. So good luck to you, aislinngrace, and everyone so involved.

            Together, with the piece each person contributes, we are making progress.

            Best wishes!

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              #7
              Myoak, always good to see you post. You do a lot of leg work for us. Keeping up with MS treatments is a full time job. I can get obsessive about it at times. But, because I am informed, my doctor does listen to me and allows me to make my own decisions about my treatment.

              Aislinnagrace, being JCV+ doesn't mean you have to give up your infusions. Of course not, are your doctor would have stopped them right then and there when you got your test results back.
              You said you just wanted to hear back from others.

              I have been on Tysabri for over 6 1/2 years. I assume JCV+ the whole time. I have been positive since the testing came out. My numbers have been from 2.4 - 4.1. I also have paid out of pocket for the big test the Mayo Clinic does that breaks down how all of your white blood cells are doing, since they pay a part in PML. An expensive test, but it gave both my doctor and I piece of mind. I can give you the information on that if you would like.

              Read read read everything. EVERYTHING. That its been working so well for you is wonderful. It doesn't work wonders for everyone. I too, have it like a cure.

              I tried going every 6 weeks between infusions and found some my symptoms returned, so went back to the every 4 weeks.

              Also inform yourself about PML. Not a good thing to get. It will a life long struggle that could be far worse than fighting your MS.

              Talk to your doctor and get his opinion. If you have a good relationship, it will help to have his opinion.

              It is a tough decision. I myself, am not a gambler, so for me it was an easy decision. Why give up something that is proven to work for me and work well, with no side effects - for something that I don't know will work or what side effects I would have. But......my doctor does not agree with me. Fortunately, they are not the ones with the final word. I am. It got overwhelming doing the research and I am "on a break" as far as that goes at the moment. And just enjoying life. The life Tysabri has given me.

              We each have to do what we think is best with the information we have at hand at the time.

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                #8
                Originally posted by jreagan70 View Post
                That optimism isn't borne out by the history of ocrelizumab. The manufacturer discontinued the clinical trials for rheumatoid arthritis after "several" (no exact number can be obtained) study subjects DIED from opportunistic infections (PML is an opportunistic infection) and other adverse events. The clinical trial for lupus nephritis (kidney inflammation) was discontinued after patients developed opportunistic infections and other adverse events.
                Just visited my MS doctor the other day who told me that ocrelizumab is basically rebranded Rituxan, at a much higher cost. I was on Rituxan for nearly 2 years with no adverse side effects. It has a long well-known safety profile for treating other disorders, so you might want to take a look at this link and read up on the two drugs. No drug is risk-free and I don't know how this new drug will differ in molecular make up, safety or risk factors but it's definitely worth considering (and Rituxan is available now).

                https://www.mscenter.org/education/p.../615-rituximab

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                  #9
                  I thought that 2.0-4.0 was indeterminate & 4.0 & higher is jcv+.
                  MS dx's 2000
                  Tysabrian

                  ¤ fate is not just who's cooking smells good, but which way the wind blows ¤

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                    #10
                    I believe the correct numbers should be .20-.40 is indeterminate.

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