Living With MS

Discussing all aspects of Multiple Sclerosis, various treatments, including accurate information regarding Tysabri.

Thursday, April 29, 2010

My Tysabri Diary...

new data just released, enjoy..:

"16 April 2010

Patient-Reported Outcomes Study Shows Improvements In Quality of Life Among Patients After One Year of Treatment with TYSABRI®

Data also showed reduced fatigue and improved cognition

TORONTO – April 16, 2010 – Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced results from a one-year, longitudinal health outcomes study (n=324) in which patients with multiple sclerosis (MS) who received 12 infusions of TYSABRI (natalizumab) reported improvements in quality of life (QoL) measures, as measured by validated tools. The goal of the study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, was to assess patient experiences with TYSABRI in a real-world setting. This research was presented in three posters at the American Academy of Neurology’s (AAN) 62nd Annual Meeting in Toronto, April 10 - 17, 2010. The AAN Annual Meeting is the world’s largest gathering of neurologists.

“Because MS is such a debilitating disease that affects patients physically, cognitively, psychologically and socially, it can have a significant impact on their quality of life,” said William Stuart, M.D., Medical Director of the Multiple Sclerosis Center of Atlanta. “These analyses, based on patient-reported outcomes, are critical to understanding the benefits of treatment with TYSABRI over the long term and in a real-world setting.”

The one-year longitudinal study assessed health outcomes from the perspective of the patient using validated patient-reported outcome (PRO) measures prior to treatment initiation and after the third, sixth and 12th infusion with TYSABRI in a real-world setting. A majority of the patients in the study were female (77.8%) with mean age of 46.7 years and mean years since diagnosis of nine years.

Quality of Life Study Results

After one year of treatment, patients reported statistically significant improvement in:

  • general health-related QoL, as measured by the 12-item Short Form Scale (SF-12v2), with higher scores indicating better QoL
  • MS-specific QoL, as measured by the 29-item Multiple Sclerosis Impact Scale (MSIS-29), with lower scores indicating better QoL

Both scales report the physical and psychological aspects of QoL in two summary scores. For both scales changes in mean scores from baseline through the 12th infusion were evaluated after adjusting for baseline patient-level and treatment characteristics.

SF-12v2 Physical Component Summary (PCS) scores improved significantly from baseline (BL 34.25, 12th 36.66; p<0.001)>.

Similar improvements were observed in the Mental Component Summary (MCS) scores, which also improved significantly from baseline (BL 43.13, 12th 46.77; p<0.001).

After controlling for covariates, a statistically significant improvement was also observed in MSIS-29 physical impact scores (BL 47.38, 12th 40.43; p<0.001).>(BL 42.01, 12th 34.09; p<0.001)>

The results of these findings are consistent with results from pivotal clinical trials and show the beneficial impact of TYSABRI on QoL in MS patients. Results show that improvements were seen as early as three months and were sustained for 12 months.

The poster titled Improvement in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab in the United States (P02.166) was made available for viewing on April 13 from 3-7:30 p.m. EDT. The poster titled Effect of Natalizumab on Disease-Specific Quality of Life after One Year of Natalizumab Treatment (P02.164) was made available for viewing on April 13 from 3-7:30 p.m. EDT.

Fatigue and Cognition Study Results After one year of treatment, patients reported:improvement in cognitive function lower impact of fatigue on daily functioning.

Cognitive function was measured by the six-question Medical Outcomes Study Cognitive Functioning Scale (MOS-Cog Scale, score range 6-36) with higher scores indicating better reasoning skills, memory, concentration, ability to start several actions at one time and ability to react. Fatigue was measured by the five-question Modified Fatigue Impact Scale-5 (MFIS-5, score range 0-20), with lower scores indicating lower impact of fatigue on physical, cognitive and psychosocial functioning.

After controlling for covariates, on average MOS-Cog scores increased significantly over time (BL 25.12; 12th infusion score 26.19, p=0.0006), indicating improvement in cognitive function, and MFIS-5 scores decreased significantly (BL 12.36; 12th infusion score 11.16,p=0.001), suggesting lower impact of fatigue on daily functioning.

TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.

Data from the Phase III AFFIRM trial highlights TYSABRI’s powerful efficacy. According to that data, which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p=0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Corporation, plc. For more information about TYSABRI, please visit, or, or call 1-800-456-2255"


Love, Lauren :)

Sunday, April 18, 2010

My Tysabri Diary...,

Whoa, the latest press release regarding Tysabri & the possible link to PML is now out..., the entire press release can be found at:

When I carefully read the press release, I noted the following information in same which I found
extremely interesting: (the bold and italicized type is mine)

'AAN platform presentation shows MS patients treated with TYSABRI experienced no substantial changes in the presence of JCV DNA, and second platform shows that patients who developed progressive multifocal leukoencephalopathy (PML) had evidence of antibodies to JCV that suggests prior infection.

One platform presents data suggesting that treatment with TYSABRI does not have a substantial effect on the presence of JCV DNA in MS patients. In the Dose Suspension Safety Assessment (n=1397) and STRATA (n=1094), JCV DNA was detected in less than 1 percent of all patients, approximately 50 percent of whom were TYSABRI naive.

The second platform presents data indicating that patients who developed PML had evidence of prior infection with JCV, as measured by the presence of anti-JCV antibodies. Investigators evaluated serum samples from TYSABRI patients who developed PML where blood samples had been collected at least one year prior to the diagnosis of PML. Most of these samples were collected prior to beginning treatment with TYSABRI. In all of these patients, serum samples were positive for JCV antibodies prior to onset of PML, suggesting pre-existing JCV infection in these patients.

Even though I'm not a doctor, this suggests to me what I believed & have been posting here and on the different MS boards all along -- that being the patients who developed PML and were previously immune compromised due to being on previous medications such as Azathioprine/Imuran, Methotrexate, Novantrone, Remicade, etc., and then became Tysabri patients, when they already had the JC virus which was no longer dormant--this is when Tysabri started getting the bad rap for causing PML, which has been proven NOT to be the case--it was the prior medications which left them immune compromised and with them already having the dormant JC virus (and we now know this because they showed antibodies to the virus in the testing/trials) which became activated because of this prior condition, thus causing PML.'

Somehow, I feel vindicated as a patient on Tysabri therapy.

Have a good day everyone.


Love, Lauren :)

Thursday, April 15, 2010

My Tysabri Diary.....,

Hi everyone, there has been much discussion and confusion regarding whether or not the test/assay is available for patients to test for the JC virus.

A neurologist friend of mine that is Touch Certified, and has many patients of his on Tysabri, informed me of the following with regard to the JC assay/test:

"The blood assay/test is not a direct test for JC Virus, but a test for antibodies to the JC virus. The theory being 'all previously exposed to JCV will have developed antibodies to the JC virus. No exposure, then no antibodies and then no risk for PML', that is the theory anyway. It is my understanding that all TOUCH facilities may request to join the trial. The first 9000 current Tysabri patients will be given the tests at no charge, and Biogen will pay the doctor/infusion center for the extra time involved."

Once I get more information as it becomes available from him, I will post it.

Have a good day everyone!

Lauren Cool

Wednesday, April 14, 2010

Hi everyone, I completed my 46th Tysabri infusion yesterday. I wish I could say it went without a hitch, but after being stuck three times with a needle to get an open line-I was left bruised and battered. I now have three different bruises on my arm, two the size of thumbnail prints on my left arm and one bruise the size of a softball on my right arm which is really hurting today, but at least I got my Tysabri yesterday.

I have been discussing Tysabri with a current Tysabri patient and she asked me the following questions via an e-mail. I need to go rest my arm now as it is starting to hurt again, take care everyone-Lauren

Subj: Re: Tysabri
Date: 4/14/2010 12:51:29 PM Pacific Daylight Time
Sent from the Internet (Details)

Hi again XXX,

It respond to your questions:

In a message dated 4/13/2010 11:10:13 PM Pacific Daylight Time, writes:

I wanted to ask you...
have you heard whether or not they have a test.. blood test??? to determine whether or not we are positive for the JC Virus??? cuz after being on Ty for over 2 years or so I know "they" are somewhat more concerned about the possibilities for the dreaded... PML
my doc said he thought it was developed and available but he was not sure what to actually "order" so I could be tested...
also how do you feel about "drug hoidays" from tysabri...
I do not want to take a drug hoiday... I want to continue taking it with no break...
How do you feel about this???

Yes, there is a blood test available to check for the JC virus, but I am unsure whether or not it is available to the general public or whether or not it is only available through a trial where it is being tested..., I am also unsure whether or not the test is for a dormant version of the JC virus you may or may not be carrying or an activated version of the JC virus-your neurologist needs to call Biogen himself & request further information as to what he needs to " order" for you. I'm sorry I don't have the exact information you need, but your neurologist needs to get this information directly from Biogen.

As to "drug holidays" my neurologist does not believe in them because there is no scientific data supporting drug holidays. In fact, the Tysabri label states at the end of page 6 & the beginning of page 7:

"Experience with monoclonal antibodies, including TYSABRI, suggests that patients who receive therapeutic monoclonal antibodies after an extended period without treatment may be at higher risk of hypersensitivity reactions than patients who received regularly scheduled treatment. Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption. Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients". ..., in other words, my neurologist is not willing to put me at a higher risk for developing hypersensitivity reactions, antibodies to Tysabri, and then experience a reduced efficacy of the medication should I interrupt my dosing schedule and then recommence my Tysabri therapy.

I just completed my 46th Tysabri infusion yesterday, have been on this medication for more than three years, and both my neurologist and myself are quite pleased that I have not had a relapse nor any new active lesions for more than three years, so neither one of us plan on stopping Tysabri for a so-called "drug holiday".

Hope this information is of some help to you. Take care dearheart--

Lauren :)

Monday, April 05, 2010

Happy Easter everyone, on this blessed day I would like to share an
e-mail that I received from a patient considering Tysabri therapy, and
my answer to him (I believe he's going to switch to Tysabri therapy),
and a wonderful video (link and lyrics below) that celebrates Easter for
those of us who believe.

And even if you don't believe in Easter, I wish all of you many, many
blessings on this wonderful day!

((((hugs to everyone))))

Love, Lauren :)

Subj: tysabri
Date: 4/2/2010 8:18:45 PM Pacific Daylight Time
Sent from the Internet (Details)

Hi Lauren.
My names Craig im 31 years old, and was DX in dec 2006, been on Rebif for a like almost the whole time, and now recently, well on tuesday my doc, says that the Rebif isnt working that im pretty much injecting water in my body. He asked me if i wanted to take Tysabri, and told me about PML, which yeah i will be honest it worried me a little bit, but its not my main concern really, its just the feeling is this right for me, ive been reading blogs of yours and others, and im seeing a lot of great things about it, and i love the fact of once a month getting it, im sick of the shots, cause the doctor now said to try copaxone while i make my descion on it, and shots everyday is definately not me, even knowing im hearing some good things about it, but anyway, to kinda get to the point, ive been trying to get peoples input on what i should do, and since reading your blogs, you seem like you might no more about this than some doctors might know, and figured i had nothing to lose if i send you an email, to kinda get your input on this whole thing, basically do you think i should go on tysabri right away, or should i try copaxone a while. any help would be great. thanks
p.s. physically im doing alright, my legs get weak alot, im tired alot, my memory is so so, i kinda forget the short term stuff, but i seem to remember everything, just not when i want to, maybe im just getting old,lol, i just ache alot and cant do what i used to do, anyways i hope that might help in giving me any ideas that you may have too, thanks again

Subj: Re: tysabri
Date: 4/3/2010 2:40:57 PM Pacific Daylight Time
Sent from the Internet (Details)

Hi Craig, it's so nice to meet you! And thanks so much for your e-mail..., I am more than happy to try and answer your questions:

In a message dated 4/2/2010 8:18:45 PM Pacific Daylight Time, XXX writes:
since reading your blogs, you seem like you might no more about this than some doctors might know
Oh my gosh, you are too funny Craig! I have been researching and studying this drug since 2000, have some neurologists as friends that have patients on Tysabri, and met the researcher/scientist/doctor that discovered Tysabri--so I do have a little bit of knowledge about Tysabri, heehee.

As far as going on Copaxone (the least effective of the ABCRs, and that's if it starts working after six months), why risk have a major relapse during that time? The ABCRs are only 29%-34% effective at preventing further relapses and slowing the disease process down, whereas Tysabri is 68% effective at preventing further relapses, slowing the disease process down, improving the patient's Quality of Life, and has proven data showing improvements in some patients. You might want to read the following proven data about Tysabri:

TYSABRI® Demonstrate Significant Improvements in QoL

TYSABRI® Demonstrates Sustained Improvement in Function

TYSABRI® Promotes Remyelination & Suggests Improvements In Symptoms

TYSABRI® Provides Greater Treatment Satisfaction As Reported By MS Patients

***ABCR Comparison & TYSABRI® Shows Reduction in Steroid Use/Hospitalizations

Tysabri Brochure

As far as PML is concerned, this occurs when the immune system becomes too low to fight any dormant JC virus you may carry in your system. Most researchers now believe that 50% of the general population (including MS patients) carries the dormant JC virus-which means that 50% do not carry the dormant virus.

Medications such as Azathioprine/Imuran, Methotrexate, Novantrone, CellCept, Raptiva, Remicade, Rituxin, etc. have all been associated with PML because their effects can last in the body for a very long time even though discontinued by the patient. Even treatments such as IVIG treatments, regular pulse steroids and the like, can severely lower the immune system.

Therefore, from what you tell me Craig, you haven't had any of these medications or treatments previously, so I really would not be concerned at all about PML. There are currently over 60,000 patients on Tysabri therapy, do you think any of them are concerned about PML? (That was a silly-rhetorical question-heehee).

Lastly, since you were recently diagnosed with MS within the last 3 1/2 years, and you are still fairly young, in my opinion (remember, I am not a doctor) you stand a very good chance of being a patient in the category that experiences drastic improvements since the damage done from your previous relapses is probably/hopefully not permanent but only temporary.

I have had 45 Tysabri infusions and experience almost zero side effects from Tysabri, whereas the interferons (Avonex, Betaseron, & Rebif) all have flulike symptoms as side effects, and Copaxone can cause welts/lumps at the injection sites as well as anaphylactic shock, etc.

Please keep me informed as to what you and your doctor decide Craig, and if I can be of any help, please do not hesitate to write me at any time.

In the meantime, I send you many, many supportive thoughts and prayers--

Lauren :)
Here is the beautiful video I mentioned above ( link is below):

How Deep Is the Father's Love for Us

How deep the Father's love for us
How vast beyond all measure
That He should give His only Son
To make a wretch His treasure

How great the pain of searing loss
The Father turns His face away
As wounds which mar the Chosen One
Bring many sons to glory

Behold the man upon a cross
My sin upon His shoulders
Ashamed I hear my mocking voice
Call out among the scoffers

It was my sin that held Him there
Until it was accomplished
His dying breath has brought me life
I know that it is finished

I will nost boast in anything
No gifts, no power, no wisdom
But I will boast in Jesus Christ
His death and resurrection

Why should I gain from His reward
I cannot give an answer
But this I know with all my heart
His wounds have paid my ransom