Personal diary – MS Spasms abruptly disturb a quiet night’s sleep

hi, it has been a while.. and this is an unusual post from me… but… Im scared.. :/

I had a very strange and painful incident this Sunday. My whole body was spasming/twitching in the middle of the night (at about 3am). It lasted a good 20-30mins:( After I took some paracetamol and drank a bit it went away. The strange thing is that it was just like the flu like symptoms I had after my first interferon/avonex injection (as expected, being a side effect), but I haven’t had it since then..and that was ages ago (2005!)

And so yesterday my whole body was aching and even before I went to bed I could feel it in my arms and legs. Not the spasming, but more like pain in the muscles/joints. And every time when I got up to pee last night I had such difficulties walking because my right foot went completely numb! :(

I stayed at home today, couldn’t go to work :( Luckily I have a Tysabri appointment later this afternoon so I will talk to a doctor, see what he/she can tell me.

So what does my mind start wondering about..? I am thinking of it nearby? Is it time? Just thoughts going through my mind..stupid thoughts. Will my boyfriend stay with me despite my potential disabilities? Although he really truly does love me, and I know that, can’t help but worrying on his behalf if he ends up with a challenged girlfriend…even though I know he knew from the beginning what MS could bring… silly huh? maybe you’ve had the same thoughts going through your head.. I just always think of the OTHER person, and how do OTHERS feel and how would this/that make THEM feel – it seems I always put others first rather than me, and my feelings and needs. I might need to work on that… but maybe it is just the way I am and I wont be able to do anything about it..

Just so you know, I have been on Tysabri since January 2009 (after Avonex failed on me following 4 years of weekly injections *chills*) and I have been very happy with it. I also have been confirmed, and re-confirmed that I (unfortunately) also carry the JC Virus.

Anyways, I am worried but I hope it is just a bad relapse… You are more than welcome to share your experiences with me, I’d be happy to hear from you!

Thanks! and stay positive;)


Quick update on Tysabri & PML!

and how we’re “only money making machines”….


ps. sorry for not being able to write more..I have a whoooole bunch of updates I want to write about but I’ve been super busy with my new job and don’t have time.. I will however do it asap!!

best to ya all and take care!!!

PML (Tysabri) update – May/17/2010!!!!

From the website (news updated today – May 17th 2010)

As of May 6th 2010, information released by Biogen Idec reports a total of 49 confirmed cases of PML (progressive multifocal leukoencephalopathy) among people on Tysabri® (natalizumab) since July 2006, when it became available for prescription.

The risk of developing PML stays the same, that is, it increases with the number of Tysabri infusions received. However, the clinical benefits of Tysabri still continue to outweigh the potential risks.

As of the end of March 2010, 67,700 people worldwide have used Tysabri since it was marketed. Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the U.S. FDA and the sponsor have released data suggesting that the risk increases with increasing time on therapy, starting out lower than the one-in-one thousand level that was estimated at the time of Tysabri’s re-approval in 2006, and rising after two years of infusions to about one in one thousand. (….) There is insufficient information to determine the risk of PML in those who have been on therapy for three years or more.

The following paragraphs below are directly quoted from the website mentioned above as I thought they are easy to understand and rather important and wouldn’t want to leave something out by mistake.

Signs of PML: Typical symptoms associated with PML progress quickly over days to weeks, and can include:
• personality or behavioral changes
• changes in thinking, memory, and orientation leading to confusion
• onset of seizures, clumsiness or progressive weakness on one side of the body
• disturbances of vision

If individuals taking Tysabri experience new, unusual symptoms, they should contact their prescribing physician immediately. Physicians who need guidelines on the protocol to follow when they have a patient on Tysabri who experiences unusual symptoms should contact Biogen Idec.

Additional Details: According to the company, as of May 6, 2010 there have been 49 confirmed cases of PML, occurring in both men and women who had been given infusions of Tysabri every four weeks for a duration ranging from one year to three and a half years, with an average of two years.

• 27 of the cases occurred in Europe, 19 in the United States, and 3 in the rest of the world.

• Approximately one-fourth of those who have developed PML have died.

• The degree of disability in the survivors is a wide spectrum: at the milder end, some have recovered enough to return to work, and at the other extreme, some are confined to bed, requiring extensive assistance with activities of daily living, and others were in between this range.

• Based on these cases, the sponsor stressed that, contrary to prior information, the presence of gadolinium-enhancing lesions on MRI does not exclude the possibility of PML. Likewise, the absence of JC virus DNA in the spinal fluid does not exclude PML.

• There has been no characteristic among those who have developed PML that would give substantial clues to who might be more likely to develop it, except that half of the cases had prior histories of having been on immunosuppresive therapies, such as mitoxantrone, and less commonly, azathioprine and methotrexate.

• Right now there is no test that can predict who is more likely at risk for developing PML while using Tysabri; in a large company-sponsored study, testing of blood cells, plasma, serum and urine for the causative JC virus in people before and after 48 weeks of Tysabri therapy (Rudick et al, ECTRIMS 2009) did not show any differences in the presence of the virus in those fluids. The results of these studies, performed at the U.S. National Instituties of Health, differ somewhat from an earlier study (N. Engl. J. Med. 361:1067, 2009) suggesting higher virus levels after treatment.

• When PML was suspected, Tysabri infusions were halted. There is no specific therapy to treat PML, but the best hope is to reconstitute a person’s immune responses. In most of the cases, once PML was confirmed, Tysabri was removed from their systems with the blood-cleansing treatments of either plasma exchange or immunoadsorption.

• During the aftermath of PML, as the immune system begins to recover, a condition called IRIS (immune reconstitution inflammatory syndrome) usually occurs about 4 weeks after the removal of Tysabri from the system. The sponsors suggested that some of the treating physicians found that prompt use of intravenous steroids to treat this brain inflammation led to improvement.

Two types of MS = Two different responses to Beta-Interferon

Medical News Today (article first reported on March 29th)

The article in question mentions a Stanford study – the discovery of two types of MS, which are based on the two different responses that patients have to beta-interferon.

The study was conducted on both animal (animal model of MS – called experimental autoimmune encephalitis -EAE) and human blood samples. The patient’s responsiveness to interferon beta (the first-line drug given to MS patients) was seen as depending on the version of MS that the patient has.

These findings need to be confirmed in larger human studies and by other laboratories, and when that is done this would mean that MS patients some day might be able to take a simple blood test to see whether they are likely to respond to treatment with the standard multiple-sclerosis therapy, said senior study author Lawrence Steinman, MD, the George A. Zimmerman Professor of Neurology and Neurological Sciences at the Stanford University School of Medicine. He also added: “I think this has the potential to transform the way we take care of people with multiple sclerosis.” He said a simple, already available blood test could spare many patients the inconvenience and side effects – and spare the health-care system the expense – of a drug that most likely won’t do any good. “The other side of the coin is that beta-interferon, if it’s given only to those who are predisposed to respond to it, could turn out to be a far better drug than we ever imagined.”

Beta-interferon’s overall efficacy is only fair, he said, with perhaps half of all multiple-sclerosis patients experiencing an average one-third reduction in recurrences. Plus, its discomfiting side effects – flulike symptoms – can make compliance an issue for patients, especially given the drug’s iffy efficacy.

And just a final note: earlier work by Steinman, proceeding from animal models to clinical trials, led to the development of another blockbuster multiple-sclerosis drug, natalizumab, marketed under the trade name Tysabri (the treatment I’m currently on and so grateful for).

PML – Tysabri – better management

Just brief information update (from Medical News Today) regarding PML/Tysabri management measures..

European Medicines Agency Recommends Additional Measures To Better Manage Risk Of Progressive Multifocal Leukoencephalopathy (PML) With Tysabri

January 22nd 2010

The European Medicines Agency has finalised a review of  Tysabri (Natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by the JC virus. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the risk of developing PML increases after two years of use of Tysabri although this risk remains low. However, the benefits of the medicine continue to outweigh its risks for patients with highly active relapsing-remitting MS, for whom there are few treatment options available.

The new measures were then mentioned in the above article but also in the following one four days later (see towards the end):

European Drugs Watchdog Finds Benefits Of Tysabri Continue To Outweigh Risks

January 26th 2010

The European Medicines Agency (EMA) has finalised a review of Tysabri (Natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by the JC virus.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the risk of developing PML increases after two years of use of Tysabri although this risk remains low.

It also stated, however, that the benefits of the medicine continue to outweigh its risks for patients with highly active relapsing-remitting MS, for whom there are few treatment options available.

As a result of the review, the Committee recommended a number of measures be put in place to ensure that patients and doctors are fully aware of the risks of PML.

These include:

– an update of the product information to add information about the increase in the risk of PML after two years of treatment and additional advice on how to manage patients who show signs of PML;

– forms to be signed by patients at the beginning of treatment with Tysabri, and again after two years of treatment, after in-depth discussions about the risk of PML with their doctor.

Tysabri — a drug haunted by a deadly side effect or is it?

I have come across a rather interesting and good article a few days ago, which covers all perspectives regarding the positives & negatives about Tysabri / PML….

It is rather interesting..and a bit long maybe but it sums up quite a few interesting insights. It starts by saying how PML went from being a rather unknown brain infection back in 2005, and generally considered a ‘death sentence’…to being not as deadly as first feared… the author then shows a table that shows what is most haunting for all of us on Tysabri..namely the PML cases/deaths:

Nr. of patients who have taken Tysabri Nr. of PML cases Deaths
Feb.2005 3,000 3 2
18.Nov.09 63,000 27 5

For more information on the ‘nature & politics’ behind this ‘haunted’ drug visit go under Links to the right “Tysabri – the ‘haunted’ MS drug” and if you want to read more on the report on the increased cases of PML then visit the link “PML – 23 new cases!”


I was shocked to discover that this was reported a week ago. As a Tysabri patient I’d say this new information is rather alarming…:S

And I quote:

Shares of Biogen Idec and its Irish partner Elan dropped this morning after European regulators said they are taking a new look at the risk and benefit of natalizumab (Tysabri) for multiple sclerosis, now that 23 patients on the drug have been diagnosed with a rare, potentially fatal brain infection called PML.

The European Medicines Agency said it has initiated the review to discuss any additional measures necessary to ensure the safety of natalizumab, according to a Reuters report.

The new report was bound to alarm some investors, because 23 cases of progressive multifocal encephalopathy, or PML, is significantly more than the tally of 13 cases the FDA counted last month. Cases of PML have been adding up since the drug was re-introduced to the U.S. market in July 2006 after it was previously withdrawn because of the risk. Despite the chance of the infection, which the FDA pegged at about 1 in 1,000, patients have continued to seek out the treatment, which physicians say is the most effective therapy on the market for multiple sclerosis. (Natalizumab is also approved as a treatment for Crohn’s disease.) More than 46,200 people worldwide were taking the drug at the end of September, Biogen said earlier this week.

Biogen finance chief Paul Clancy told Dow Jones earlier this week that the company will discuss how to communicate the link between long-term use of the drug and increasing incidence of the dangerous side effect.

Regulators might choose to recommend that patients who take the drug for long periods of time take breaks, or “drug holidays,” said analyst Christopher Raymond of Robert W. Baird & Co., in a note to clients this morning. Since so many patients depend on the product to control their symptoms, it’s unlikely that regulators would force it off the market, he said.

“We deem it highly unlikely that either FDA or EMEA would pull Tysabri from the market,” Raymond said. “With PML risk well known, we think the most likely scenario would be additional labeling restrictions suggesting perhaps a drug holiday after an extended treatment period.”

[Updated comment from Biogen Idec.] There isn’t any data that suggests imposing a drug holiday would reduce the risk of patients getting PML, but there is data that shows symptoms of multiple sclerosis return quickly once patients quit taking natalizumab, says Biogen Idec spokeswoman Naomi Aoki. The company is talking with regulators about the best way to update the drug’s prescribing information to reflect the increased risk with extended usage, but even so, the incidence of PML still appears within the stated range of 1 in 1,000 patients, she says.

for more details please see under Links: “PML – 23 new cases”

Previous Older Entries