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Thread: ACTRIMS keynote address on Ocrevus (ocrelizumab), the first B-cell therapy

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    Distinguished Community Member agate's Avatar
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    Default ACTRIMS keynote address on Ocrevus (ocrelizumab), the first B-cell therapy

    The annual ACTRIMS conference was held last month in Orlando, FL. ACTRIMS = Americas Committee for Research and Treatment in Multiple Sclerosis. Stephen L. Hauser, MD, who gave this keynote speech at the ACTRIMS conference, is well known in MS research, and his remarks emphasizing the importance of the new drug, ocrelizumab, might be a ray of hope:

    Kenneth P. Johnson Memorial Lecture: Multiple
    Sclerosis in the Age of B-cell Therapy


    Dr. Stephen Hauser – University of California – San Francisco

    A significant conceptual change in understanding MS
    has been a new appreciation of a role of autoimmune B cells in
    mediating tissue damage. In MS, B cells cross the blood-brain
    barrier and undergo stimulation, antigen-driven affinity maturation
    and clonal expansion within the supportive CNS environment;
    activation and expansion of these putative disease-causing
    cells also can occur in the peripheral lymphoid system. These
    highly restricted populations of clonally expanded B cells and
    plasma cells can be detected in MS lesions, in cerebrospinal fluid,
    and also in peripheral blood.

    Monoclonal antibodies that target circulating CD20-positive B lymphocytes
    dramatically reduced disease activity in relapsing forms
    of MS, and also were effective, although more modestly so, in the
    primary progressive form of the disease. The beneficial effects on
    relapsing MS occurred within weeks of treatment, indicating that
    a direct effect on B cells—and likely not on autoantibodies—was
    responsible. Indeed, the discovery that depletion of B cells has a profound
    impact on MS biology enabled a paradigm shift in understanding
    how the inflammatory phase of MS develops, and will hopefully
    lead to development of increasingly selective therapies against culprit
    B cells and related humoral immune system pathways.

    The expected launch in early 2017 of ocrelizumab, the first B-cell
    therapy to be approved by regulatory agencies, will significantly
    alter the MS treatment landscape. However, questions remain
    about its proper role. Is a highly effective drug such as ocrelizumab
    appropriate as initial therapy for all patients with newly
    diagnosed MS? Is lifelong treatment required, or is induction therapy
    followed by monitoring and/or maintenance - analogous to a
    cancer strategy – adequate? Which patients with progressive MS
    should be treated? And finally, what are the advantages of ocrelizumab
    relative to other therapies, used off-label or under development,
    that also target CD20 or other B-cell surface molecules?
    Last edited by agate; 03-07-2017 at 10:48 AM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Distinguished Community Member BBS1951's Avatar
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    Within weeks! That's very impressive. Does it have the same deadly side effect profile as some of the other mab's?

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    Distinguished Community Member agate's Avatar
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    Well, there was this:

    Side effects: As an immunosuppressive drug, it could come with a risk of PML, but Dr. Krupp says the risk appears to be significantly lower than with natalizumab. No cases were reported in the clinical trials, although some have been reported among the four different medications in this class (rituximab, ofatumumab, and ublituximab are the other three). In both phase 3 trials of ocrelizumab, patients taking the drug had higher rates of cancer than the control group. Many experts are excited about this new drug, but others are concerned that the long-term risks or complications are unknown because it hasn't been studied over a long period of time.
    --from an article in Neurology Now, February/March 2017, previously posted here:

    http://www.braintalkcommunities.org/...atment-options

    And there's this:

    So far, Ocrevus’ safety profile in MS program is very strong, but some question marks remain. The most common adverse events associated with Ocrevus treatment in the Phase III MS program were infusion reactions (mostly mild-to-moderate) and non-serious infections (e.g., nasopharyngitis). However, most MS experts interviewed by DRG [Decision Resources Group] took note of malignancies that were observed: Four malignancies were reported in the relapsing MS studies, compared with two in the Rebif arm, and 11 malignancies were reported in the Ocrevus arm of ORATORIO, compared with two in the placebo arm (enrollment was 2:1, respectively).

    Previous development of Ocrevus in non-MS populations was beset by serious, including opportunistic, infections that led to several fatalities and halted development in those arenas. Although experts express some mild concern over these side effects, they do not extrapolate the risk to MS patients; the diseases are meaningfully different in their clinical characteristics and concomitant medications. Separately, sporadic cases of progressive multifocal leukoencephalopathy (PML) — the singular drawback of Biogen’s Tysabri (natalizumab) in the treatment of MS — have been reported in non-MS patients who received Rituxan. In fact, Rituxan’s label carries a black-box warning for potentially fatal infusion reactions and PML. Ultimately, interviewed KOLs [key opinion leaders] suggest that PML risk could also feature in Ocrevus’ label based on this data, but they consider the risk in MS patients to be remote.
    The entire article, "Genentech's Ocrevus" in Pharmaceutical Online (November 30, 2016), which contains quite a bit of information, can be seen here:

    https://www.pharmaceuticalonline.com...landscape-0001

    Since this article is from a Website that is probably allied with drug industry interests, any facts presented might be questionable. For instance, the article includes a couple of charts showing how many SPMS patients were being treated with DMT in January 2016. According to the charts, 60% of US patients with SPMS were being treated with disease-modifying therapy in January 2016, and for the EU the figures were 36-59% of the SPMS patients.

    I'm sure that I've seen other data on this, and the percentage of SPMS patients receiving DMT was considerably lower.
    Last edited by agate; 03-07-2017 at 06:52 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Distinguished Community Member Howie's Avatar
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    And PML raises it's ugly head again.

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    Distinguished Community Member Lazarus's Avatar
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    http://www.medpagetoday.com/mastery-of-medicine...

    BBS1951 posted this article a few weeks ago. It has Dr. VOllmer discussing current and future MS meds and Ocrevus is discussed. ( so is rituxan which I take). The article is a great explanation categorizing our meds and also their safety outlook. Ocrevus is the next med I would look to if rituxan stopped working for me...my neuro has had me watching its development news for a few years now.


    Oh! I see Agate already posted the Vollmer article! Well, all this is such good information. When I am feeling particularly great, usually close to the time right after infusion, I try to imagine who I would be without MS and I fear that I have become my MS so throughly that I have lost myself.
    Last edited by Lazarus; 03-08-2017 at 04:56 AM.
    Linda~~~~

    Be the kind of woman that when your feet hit the floor each morning the devil says:"Oh Crap, She's up!"

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    Distinguished Community Member agate's Avatar
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    Quote Originally Posted by Lazarus View Post
    This quote is hidden because you are ignoring this member. Show Quote
    ... When I am feeling particularly great, usually close to the time right after infusion, I try to imagine who I would be without MS and I fear that I have become my MS so throughly that I have lost myself.
    MS does take over for all too many of us. But maybe it's not that we've lost ourselves. Maybe we've just been revised and edited and have come out in a new version, like some books.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Distinguished Community Member Howie's Avatar
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    Don't you think the meds MSers take are a constant reminder that we are sick.

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    I don't feel that way.

    ANN
    There comes a time when silence is betrayal.- MLK

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    Distinguished Community Member agate's Avatar
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    I didn't feel that way when I took Avonex, then Copaxone. I already knew something was wrong with me but that had been true for many years by the time I started an MS drug. So maybe I didn't need any reminders. MS was just something wrong that needed fixing, and I was doing what little I could to try to keep it from getting worse, I thought.

    Another way of putting it: I get reminders every day that I have MS. Adding an MS drug into the day didn't change that.

    Maybe some people can get through the day pretending they don't have MS but I haven't been one of them. In fact, long before I knew what was wrong with me, I knew something was stopping me in my tracks many times during most days.

    Diabetics who take insulin aren't constantly reminded that they're sick. They're not sick, in fact, if they're controlling their diabetes. So in a way when they take an insulin shot they're doing what they can to keep from being sick. That's a way of looking at the MS drugs--as a way of (maybe) keeping from being sicker.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Distinguished Community Member Howie's Avatar
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    Cool

    But you have to remember your dosing schedule, and prepare whatever it is. And you would really think about it daily, "Is this treatment helping?" What else can I try, and etc.

    I don't take an MS med, yet to remember the pill dosing schedule, I put all the pills for today in a bottle so with one glance, I can tell "Did I take the yellow pills today?" It seems after a long time, it becomes easy to miss a dose, and I have to think about it at times all day.

    Opp's, time for another yellow pill.......
    Last edited by Howie; 03-08-2017 at 02:16 PM.

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