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Thread: Notes from a Webinar led by Dr. Randy Schapiro on emerging MS therapies

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    Distinguished Community Member agate's Avatar
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    Default Notes from a Webinar led by Dr. Randy Schapiro on emerging MS therapies

    I recently listened to a Webinar on "Emerging Therapies in MS" presented by Dr. Randall Schapiro and Can Do Multiple Sclerosis (formerly the Heuga Center).

    Dr. Schapiro is President of the Schapiro MS Advisory Group in Eagle, CO, and Clinical Professor (Retired) of Neurology at the University of Minnesota.

    Here are some of the statements he made:

    --He believes that 400,000 MS cases in the US is a very outdated figure. He said it is based on data from the mid-1970s and should be much larger.

    --People with MS will get better 65% of the time--for a while--no matter what treatment they're given.


    Therapies:

    4-aminopyridine (Dalfampridine, Fampridine, Ampyra)


    A potassium channel blocker. It improves walking in more than 30% of the persons with MS who take it. It involves an increased possibility of seizures, however.

    FOR SPASTICITY--which he said is "velocity-dependent," meaning that the faster you move the muscle, the worse the spasticity gets:

    Botox
    Injected into the muscles. The effect of the injections lasts about 3-4 months.

    XP19986 (Xenoport)

    In the pipeline.

    Marinol (dronabinol)

    Marijuana in pill form.

    Sativex (tetrahydrocannabinol and cannabidiol)

    Inhaled. Reduces pain and sleep disturbance. However, its long-term effects on the lungs is an issue.

    PAIN

    Lyrica (pregabalin)

    This drug, used for epilepsy, has shown good results for MS pain.

    PSEUDOBULBAR AFFECT:

    Nuedexta (AVP-923, dextromethorpan/quinidine)

    DRUGS THAT DON'T ADDRESS SYMPTOMS BUT MODIFY THE DISEASE:

    There are now 8 of them: Rebif, Copaxone, Avonex, Betaseron,Extavia, Novantrone (mitoxantrone), Gilenya, Tysabri

    FUTURE DISEASE-MODULATING DRUGS:

    BG00012

    Antioxidant. Fumaric acid esters.

    Teriflunomide

    Campath (alemtuzumab)

    Targets CD52 antigen expressed on B and T lymphocytes. There are possible issues here, including malignant thyroid disease.


    Stem cell mobilization with cyclophosphamide


    Tovaxin

    T-cell vaccination.


    Daclizumab

    Blocks IL-2 (interleukin 2)

    Rituxan (rituximab or Ocrelizumab, which is similar)

    Binds to CD 20 antigen on B cells and induces B cell antigen

    New formulation of Rebif

    High-dose vitamin D

    Stem cells

    In response to questions, he made more comments:

    VITAMIN D: He's a little leery about the promotion of heavy doses of vitamin D in MS because lately too many diseases are being chalked up to vitamin D deficiency.

    TO TREAT MS OR NOT TO TREAT: 20% of people with MS will do well with no treatment. New drugs aren't necessary better. "They're just new."

    NOVANTRONE: This is a risky drug and can lead to leukemia. It's been used only for worsening severe cases of MS and now that newer drugs have come along, it is less popular.

    MS "BURNOUT"? Many neurologists believe that every immune system disease tends to slow down in people in their 60s and 70s.

    PONS DEVICE: A device developed at the University of Wisconsin. It stimulates the pons area of the brain and might improve strength. More study of this is needed.

    SAFETY AND EFFICACY OF THE INTERFERONS: Safety shouldn't be an issue because these drugs have been around for 20-25 years, with no big safety issues. Their efficacy depends on the individual person.

    WHY ARE THERE AGE-GROUP RESTRICTIONS IN CLINICAL TRIALS?
    The very young and the very old tend to have "oddball disease" [because MS is much more commonly seen coming on between the ages of 20 and 50]. Also, older people tend to have other disorders, which make the picture murkier.

    DISEASE-MODIFYING DRUGS FOR RRMS ONLY?

    80-85% of the people with MS have RRMS and SPMS. The others are PPMS or PRMS (progressive relapsing MS). All of the available disease-modifying drugs are for RRMS. Studies have been done with the other (progressive) forms but weren't so promising--except that a few people did respond to the drugs.

    DIZZINESS:

    Dizziness is common in MS but is also very common in people without MS. For dizziness, high-dose corticosteroids or antivertiginous drugs like Meclizine or diazepam are often prescribed.

    The entire Webinar can be heard here.

    Edited to add: There is also a segment on CCSVI.
    Last edited by agate; 08-26-2012 at 03:46 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Agate-

    Thank you for doing the work of listening, understanding and transcribing your notes. It's very helpful.

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

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    Thanks Agate, a lot of what he had to say is interesting. I wonder what the new formula Rebif is about. I have not heard this before.
    Virginia

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    I'm pretty sure he's referring to "RNF" or Rebif New Formulation, which apparently isn't so very new.

    I haven't used Rebif but the original formulation involved 3 doses a week of 22mcg each, and the new formulation is for 44mcg doses, 3 times a week, but they have also tweaked Rebif in various ways to make it more tolerable--or at least that's my understanding.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Agate, I have been on Rebif for over 10 years and once I titrated up (which took me a couple of months) I have always been on 44mcg. But maybe that is just how he refers to the 44mcg even though it has been around a long time.
    Virginia

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    Distinguished Community Member agate's Avatar
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    Virginia, thanks for straightening me out about the dosage. Looks as if it's a new formulation but Dr. Schapiro classified it under "Future Disease-Modulating Drugs." In fact he puts it this way: "There is a new formulation of Rebif out there that may eventually make its way to the U.S."

    I found this writeup of a study, but it's from over 5 years ago (Doctor's Guide, May 8, 2007):

    New Formulation Interferon Beta-1a Demonstrates Improved Safety for Multiple-Sclerosis Patients

    Presented at AAN
    http://www.pslgroup.com/dg/27A1A2.htm


    By Maria Bishop



    BOSTON, MA -- May 8, 2007 -- One-year results of a phase 3b trial of the new formulation interferon beta-1a (Rebif New Formulation; RNF) demonstrate an improved safety and immunogenicity profile at a high dose and high frequency in patients with relapsing multiple sclerosis (MS), according to research presented here at the American Academy of Neurology (AAN) 59th Annual Meeting.

    Treatment with interferon beta in MS patients can be associated with the development of neutralizing antibodies (NAbs), which have been shown to reduce the therapeutic effect of interferon at high titers, said lead investigator James P. Simsarian, MD, director, Multiple Sclerosis Program, Neurology Center of Fairfax, Ltd., Fairfax, Virginia, and neurologist, Inova Fairfax Hospital, Falls Church, Virginia.

    The new human serum albumin-free formulation of Rebif was created to minimize the incidence of NAbs and to optimize the potential benefits of treatment with interferon.

    A 96-week multicenter, single-arm, open-label study of RNF enrolled 260 adults with an Expanded Disability Status Scale score < 6.0 and a diagnosis of relapsing MS according to the McDonald criteria. Patients in the study self-injected RNF 44 mcg/0.5 mL subcutaneously, 3 times weekly.

    Blood samples were examined at weeks 12, 24, and 48, and the proportion of RNF-treated Nab-positive patients was compared with historical Rebif data from similar patients treated with 44 mcg Rebif, 3 times weekly in the Evidence of Interferon Dose-response: European North American Comparative Efficacy (EVIDENCE) study.

    At 48 weeks, 227 (87.3%) of patients were still on treatment. Patients treated with RNF were nearly 6 times less likely to become Nab-positive (titer >/= 20 NU/mL) at both 24 weeks and 48 weeks compared with patients in the EVIDENCE study.

    Incidence of prespecified adverse events was markedly lower for injection-site reaction in RNF (30%) versus historical data (84%), which represented a threefold reduction. Similar reductions were noted for cytopenia (10% vs 12%), depression and suicidal ideation (6% vs 20%), hepatic disorders (13% vs 17%), skin rashes (5% vs 12%), thyroid disorders (2% vs 5%), and hypersensitivity reactions (5% vs 3%).

    According to the authors, these changes constitute notable improvements to the typical safety profile of injectable Rebif.

    As expected with an HSA-free formulation, incidence of flu-like symptoms was higher with RNF (71% vs 48%), although most events were mild/moderate in severity.

    This study was sponsored by Merck Serono International SA.


    Last edited by agate; 08-26-2012 at 03:45 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    I've tried to find out more about Dr. Randy Schapiro, after hearing his comments on CCSVI, which struck me as more of a rant than an objective consideration of CCSVI.

    One might want to take some of his comments with a grain of salt. If ProPublica is a reputable Website (and it seems to have sound backing), Dr. Schapiro was revealed a while back as having received substantial sums from a drug company:

    Pfizer, for example, told the state [of Minnesota] it paid Dr. Randy Schapiro $1,770 last year. But on the firm’s website, it reported spending $43,827 on him in the second half of 2009 alone.
    And:

    Pfizer has submitted a revised report listing Schapiro’s pay last year as $96,889—more than 50 times what it initially said. A Pfizer spokeswoman said her company found internal problems that led to the inaccurate report.

    And:
    Hess and Schapiro, like other Minnesota physicians interviewed, said they were unaware of the discrepancies—and hadn’t looked at the latest disclosures. They said the media makes a bigger deal about potential conflicts of interest than patients do.
    “If it’s cleaned up, then I don’t personally have any problems with people seeing the numbers," said Schapiro, a specialist in multiple sclerosis who is now retired and living in Colorado but who still does speaking and consulting.

    Schapiro said the doctors paid by pharmaceutical companies are “leaders in their fields,” and patients should want to see their physician among them. “If their doctor is not on the list,” he said, “maybe they should look for a different doctor.”
    These quotations are from "In Minnesota, Drug Company Reports of Payments to Doctors Arrive Riddled with Mistakes," December 10, 2010, by Charles Ornstein and Tracy Weber.

    http://www.propublica.org/article/in...ctors-mistaken
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Agate, thanks for doing the additional research on Dr. Schapiro. I have read about him probably in MS magazines or books that I have bought.

    For me personally, it sends up a red flag when a Doctor is receiving compensation from a drug company. Don't know why he feels they are "leaders in their fields". Let's face it, the drug company will compensate the Doctors who are best touting their drug, and from the Doctor's viewpoint which drug do you think they are going to lean toward. I can't see where this is a "win win" situation for the patient.
    Virginia

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