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PML cases during dose extension on Tysabri.

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    PML cases during dose extension on Tysabri.

    Analysis of Biogen’s Touch program which tracks about 90,000 patients using Tysabri reported 15 cases of PML in patients who were on extended dosing intervals.

    Yesterday, the director at an MS Clinic told me that 6 of the 15 cases were of patients who had been on extended dosing but had gone back to standard dosing of 4 weeks. The average interval on extended dosing was 6 weeks, according to that neurologist.

    Biogen’s TOUCH program data was interpreted as follows:

    Three separate definitions of standard-interval dosing (SID) and extended-interval dosing (EID) were analyzed from the TOUCH program tracking Tysabri patients.

    The first group analysis involved those who had fewer than 15 infusions in the last 18 months compared to those who had more than 15 infusions the last 18 months. There were 3 PML cases in 1,988 on extended dosing in this group and 89 cases of PML in 13,132 on standard dosing.

    The second group analysis defined extended dosing as anyone who had ever extended dosing for at least 6 months at any time during their treatment history with Tysabri. In this group there were 12 PML cases in 3,331 on EID and 71 cases of PML in 15,424 on SID. Remember, some of the 12 cases of PML in EID had gone back to SID. Possibly, because MS was not sufficiently suppressed on EID.

    The third group analysis defined extended dosing as fewer than 10 doses per year and standard dosing as more than 10 doses per year. There were zero cases in 815 patients in this extended dosing group having less than 10 infusions per year compared to 96 cases of PML in 23,168 in the standard dosing group having more than 10 infusions per year.

    Sadly, the very bad news is that there remains a risk of PML even with EID.

    The good news is that PML risk is greatly reduced by extending time between doses.

    https://www.mdedge.com/neurologyrevi...mab-associated

    #2
    This is why Tysabri is chosen and why many want to stay on it...

    "after approximately 5.5 years of natalizumab treatment, 86.5% and 94.7% of patients did not have EDSS score increases of ≥1.0 or ≥2.0 points, respectively."

    Natalizumab treatment shows low cumulative probabilities of confirmed disability worsening to EDSS milestones in the long-term setting

    https://www.sciencedirect.com/scienc...11034818301408

    Multiple Sclerosis and Related Disorders

    Volume 24, August 2018
    Highlights:
    This long-term study examined the effects of natalizumab treatment at 5.5 years.
    Disability worsening events confirmed at 24 weeks may not be sustained at 48 weeks.
    Relapses contribute significantly to EDSS worsening.

    Quote, “… after approximately 5.5 years of natalizumab treatment, 86.5% and 94.7% of patients did not have EDSS score increases of ≥1.0 or ≥2.0 points, respectively.” End Quote

    Comment


      #3
      Thanks Myoak. I have benefitted. No change in EDSS score, starting my 8th year on Tysabri.

      Still JCV negative, still 28 days. Considering extending, but I am one of those people who really feel it when infusion isdelayed a week. I am more tired, feel not as sharp cognitively. And I guess because more tired, I feel paroxysmal symptoms that go away after infused.
      Kathy
      DX 01/06, currently on Tysabri

      Comment


        #4
        Thanks Myoak. Good information. I've read the research numerous times, but I still haven't figure out their reasoning for the differentiation between groups 1 and 3. Group 1 had 3 cases of PML versus
        group 3 that had none.

        Although JC-, I'm enjoying my "extra days" on my 6 week EID. This year I'll try every 7 weeks, with only 8 sticks for the year.

        I still believe Tysabri is still the Cadillac of MS meds (up to this point).

        Comment

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