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Thread: Tonight's Lemtrada informational dinner

  1. #1
    Distinguished Community Member Cherie's Avatar
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    Default Tonight's Lemtrada informational dinner

    David and I went to a dinner hosted by Genzyme, makers of Alemtuzumab (Lemtrada) this evening. Probably one of the driest and most boring presentations I've been to in 15 years on an MS therapy but informative none the less.

    Lemtrada was tested against 44mcg Rebif three times a week rather than placebo.
    Lemtrada patients had 40-60% fewer relapses, progression of disability, and new enhancing MRI lesions than those on Rebif.

    40 out of 100 40% people on Lemtrada develop an autoimmune thyroid disorder which is controllable with medication.
    4 out of 1000 (0.4%) develop melanoma or lymphoma
    3 out of 1000 (0.3%) develop ITP (a potentially fatal bleeding disorder)
    3 out of 1000 (0.3%) develop kidney failure

    Very close monitoring is done throughout the course and treatment and monthly for 4 years after the final dose. ( blood and urine tests monthly paid for by the drug company...not your insurance). Dermatologist visit before and annually till 4 years after the last dose at your expense.
    Most people need 5 daily doses the first year and three a year later and the majority (84%) have no further disease activity at 2 years and only slightly lower (76%) at 5 years.
    An anti-viral such as Acyclovir or Valtrex is started before the first dose and continued for 2-6 months until B cell count comes back up to a range where you are not likely to get shingles.
    Protocol is for a Gram of IV solumedrol to be given as premedication before each dose of Lemtrada but for those who cannot tolerate steroids, a premedication of physician's discretion may be used.

    There is no age restriction but this is only given for relapsing forms of MS and not progressive forms. Need to have had a relapse in the prior 2 years to qualify to go on med and have failed at least two other meds before going on this. Commercial insurances qualify for a 0 copay program but neither Medicare nor Medicaid will approve unless there is a supplemental policy that will cover cost.

    Most common side effects after or during infusion are itching, rash, headache, nausea, elevated temperature (sometimes aggravating Uthoff's sign...worsening of MS symptoms due to heat). Additionally there is a huge list of less common potential side effects.

    You cannot take it if you are HIV positive, have had thyroid cancer, hepatitis, are pregnant or planning to be or if you are breast feeding.

    The first year of therapy (5 doses followed by three a year later) costs about $140,000. Rebif costs about $100,000 a year as a comparison (8 doses versus 156 doses)

    I did ask the question: If a person has had MS for a couple of decades, is still relapsing but not returning to baseline after a relapse and has been on a disease modifying therapy that they tolerate but is not preventing relapse, are they a candidate for this medication. I was told, yes, this is a definite option for that person. It is also quite effective in aggressive MS that hits early and hard.

    For more information on this medication or to find an informational session near you, go to www.Lemtrada.com

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    Distinguished Community Member Howie's Avatar
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    Thanks Cherie. I did Valtrex daily for 2 years, until I could no longer afford it. But I can't even remember my last exacerbation. I take nothing for the last 14 years, and doing fine!
    Last edited by Howie; 11-21-2015 at 07:04 PM.
    "A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort."

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    Distinguished Community Member Cherie's Avatar
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    I'm grateful that is the case Howie. That means you are NOT a candidate for Lemtrada. thankfully.

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    Distinguished Community Member Howie's Avatar
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    That's good news!!!!
    "A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort."

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    Distinguished Community Member SuzE-Q's Avatar
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    Thanks, Cherie,

    Couple questions came up,

    1. How can most participants have no disease activity after 3 or 5 years when it's supposed to result in 40-60% fewer relapses, MRI activity and progression compared to Rebif users, which itself is only sightly more than 10% better results than placebo, and overall, Rebif is only reported to reduce relapses by a 1/3? The numbers don't seem to add up to 76% and 84% having no disease activity at all after 3 and 5 years respectively if it's compared to Rebif in this way.

    2. If shingles is such a risk, were there stats given on the # of people who developed it if it's such a risk that people are put on meds prophylactically? It's not listed in your stats of side effects.

    3. Were you given specific on its efficacy for longterm RRMSers, or was it just a guesstimate on the rep's part? Would there be more risk, given the # of other treatments likely tried first?

    4. I just recently posted how the first few IVMP help MS - if this is given in conjunction with Lemtrada, how do they know what effects are attributable to Lemtrada and not the steroids?

    5. If the risk of infection is increased, does that include PML?

    6. Are the dermatologist visits covered by the drug manufacturer too?

    7. Did anyone say why melanoma risk increases?

    Do you think this gave you any additional info than the clinical data already available would? Thanks!

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    Distinguished Community Member agate's Avatar
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    Thanks so much for sitting through the presentation and reporting the information here, Cherie. I hope that at least the dinner was edible.

    SuzEQ, it looks as if the patient pays for the dermatologist visits.

    I have a couple of questions about them. Are they required? Why are they needed for 4 years after stopping Lemtrada? Is the risk of melanoma the reason?
    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 Lazarus's Avatar
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    I was very excited about Lemtrada. When I brought it up to my neurologist as a possibility after Rituximab stops working as well as it does for me, his response was an immediate no. I was surprised at his clear response!
    He said that if I took Lemtrada and if it was not effective for me that I would have to wait a year before I could try anything else.
    I am pretty sure that was what he said. I know the question you think I asked is "why" but I did not ask. I immediately jumped to evaluating other possibilities. I have had the same neurologist for 20 years and paid attention when he was so adamant.
    I did deal successfully with a malignant melanoma some years ago and that may factor into things but I think the question is important to ask if anyone is considering it. If the Lemtrada does not work for you does that inhibit how soon you can try another drug?

    That's all I know about it. I am lucky that Rituximab is still a great drug for me.
    Linda
    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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  15. #8
    Distinguished Community Member Cherie'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
    If the Lemtrada does not work for you does that inhibit how soon you can try another drug?
    Linda
    I asked that question as well and was told that so few people have required additional therapy after the initial two courses that they generally get another three infusions of Lemtrada at year three or four if needed. It presenter (Dr. Katz) said there was no information that he had seen about moving onto another drug after Lemtrada but does not know why it would negate using something else if it was felt to be necessary. The reason we wait a year is that both B and T cells are depleted with the dosing of Lemtrada. B cells return in 2-6 months (at which time the anti-viral can be stopped) but T cells take 8-12 months to return. The next course of therapy (including Rituxan) cannot be given until both levels return to more normal levels without risking severe infections. At least that is how I interpreted what he was telling us. He was not overly clear in his explanations and I think of the 20 of us in the room, likely only a half dozen really understood the implications of what was being discussed. The majority if attendees I KNOW have been cane dependent for years and most have not had a relapse in a very long time.

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    Distinguished Community Member agate's Avatar
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    Linda, so far I haven't found any specific recommendations about how long you'd have to wait after stopping Lemtrada before starting another MS drug but it sounds as if there are restrictions.

    What is the washout period?
    The effects of treatment are thought to persist for at least 1 to 2 years after the last dose.

    and:

    Preliminary data also suggest that the risk of autoimmune side effects from treatment with alemtuzumab appears to be highest between 3 and 4 years after treatment.
    These are excerpts from "Information for Healthcare Professionals" about Lemtrada:

    http://ms-coalition.org/emergingther...g/alemtuzumab-lemtrada
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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  19. #10
    Distinguished Community Member Cherie's Avatar
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    Quote Originally Posted by SuzE-Q View Post
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    Thanks, Cherie,

    Couple questions came up,

    1. How can most participants have no disease activity after 3 or 5 years when it's supposed to result in 40-60% fewer relapses, MRI activity and progression compared to Rebif users, which itself is only sightly more than 10% better results than placebo, and overall, Rebif is only reported to reduce relapses by a 1/3? The numbers don't seem to add up to 76% and 84% having no disease activity at all after 3 and 5 years respectively if it's compared to Rebif in this way.

    He did say that as we learn more about the drugs on the market, we are seeing far fewer relapses than was initially reported in the original clinical trials. The average person on Rebif is having a relapse every three years while those not on medication are relapsing 1-2x/year. On Lemtrada, after 5 years only 26% had had a relapse

    2. If shingles is such a risk, were there stats given on the # of people who developed it if it's such a risk that people are put on meds prophylactically? It's not listed in your stats of side effects.
    In Table 1 from the Professional Resource Website for Genzyme, 165 of the 811 patients on Lemtrada in a 2 year period developed a herpes viral infection (shingles or other) versus only 35 of the 389 patients on the REBIF control arm.

    3. Were you given specific on its efficacy for longterm RRMSers, or was it just a guesstimate on the rep's part? Would there be more risk, given the # of other treatments likely tried first?Again, I asked that question specifically. There has been none of the risk of PML or severe immunosuppression that is seen with Tysabri. I asked about use of Novantrone or Cytoxan and he said those are not used anymore. Well I know of three persons currently on Novantrone and Many on Cytoxan. He said where he works in NJ those drugs haven't been used in more than a decade but "Partners seems to love them." (boston) Responses as sweeping as this from him made him a bit less believable to me and needing caution when making decisions.

    4. I just recently posted how the first few IVMP help MS - if this is given in conjunction with Lemtrada, how do they know what effects are attributable to Lemtrada and not the steroids?They don't! Which is why they are OKing the use of alternate premedication at the discretion of the prescribing physician and patient. If patients are given something to manage nausea, temperature elevation and itching (such as Zofran, Tylenol and Benadryl) they seem to have fewer side effects such as joint pain, insomnia, tachycardia, Anxiety, chest discomfort.

    5. If the risk of infection is increased, does that include PML?"So far we have not seen it"

    6. Are the dermatologist visits covered by the drug manufacturer too?No

    7. Did anyone say why melanoma risk increases? No but the increase is minimal...from 0.2% to 0.4% or 4 per 1000 persons instead of 2 per 1000 patients.

    Do you think this gave you any additional info than the clinical data already available would? Thanks! I actually got more from speaking with the Professional Resource Division spokesperson at Genzyme and from the inservice provided by the International Organization of MS Nurses (IOMSN) than I got in the handouts or presentation last night. It was my opinion that Dr. Katz was flying by the seat of his pants on some of the answers given rather than from observation or personal diagnosing and treating experience.
    I have entered answers in the text above. As an aside, at the Consortium of Multiple Sclerosis Centers(CMSC) annual meeting in May, there were several presentations on Lemtrada and discussions about it. Virtually everyone who had been part of the clinical trials (docs...not patients...) were thrilled with the results and said that they expected more discomfort in their patients than was reported. Everyone seemed to tolerate it well and most, by 2 months after the first series were back at or even improved from baseline when starting the med. There was also considerable improvement in about half of the persons by the time the second three day course was administered that had improved on the 25 foot walk, 9 hole peg test and EDSS scores and that improvement in most continued through the second and third year followup. There is now a 5 year followup that was published a couple of weeks ago that confirms this. I will try and find that and post a link to it. These are great questions!

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