Living With MS

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

Monday, August 25, 2008

Good news regarding Tysabri, woo hoo!

This is wonderful news Re: those who are concerned about developing PML with the use of Tysabri..., let me briefly explain what my neurologist told me about PML: PML occurs when the immune system has been compromised (or becomes so low that it cannot fight off the JC virus which causes PML to occur)... Plasma Exchange or Plasmapheresis helps to rapidly remove Tysabri from the body, thereby reconstituting (or making strong again) the immune system..., I hope that the following information helps calm the fears of those who are afraid of Tysabri(a.k.a. Natalizumab)....,

Here is the article:

Plasma Exchange Accelerates Natalizumab Clearance

Robert Fox, MD, Cleveland Clinic Foundation, Cleveland, Ohio, reported results of studies that showed that plasma exchange (PLEX) accelerates the clearance of natalizumab, an anti-alpha 4-integrin monoclonal antibody, and restores leukocyte migration into the central nervous system, thereby potentially improving the clinical outcome of patients who have suspected or confirmed cases of progressive multifocal leukoencephalopathy (PML).

The risk of PML, an opportunistic viral infection of the brain, is increased with natalizumab treatment, and, Dr. Fox noted, immune reconstitution is currently the only effective intervention for improving outcomes in patients with PML. In one study, 12 patients with MS who had received at least 3 monthly infusions with natalizumab 300 mg received three 1.5-volume exchanges, over 5 or 8 days, performed 10 to 14 days following their last natalizumab infusion. Mean serum natalizumab concentrations, monitored throughout the PLEX course, were reduced >95% from baseline immediately following PLEX, Dr. Fox reported, and natalizumab clearance was accelerated by 75 days compared with natural decline.

In a second study, performed in a subset of 6 of 12 patients, peripheral blood mononuclear cells (PBMCs) were assessed for chemokine CCL2-induced migration using an in vitro blood-brain barrier (ivBBB) model during natalizumab treatment and following PLEX. PBMC migration across the ivBBB was shown to increase by 2.2 fold after PLEX.

Based on the results of these studies, Dr. Fox noted that PLEX offers potential for immune reconstitution in potential PML cases associated with natalizumab treatment.


Love, Lauren :)

Monday, August 18, 2008

My Tysabri Diary...PML is no longer the "Kiss of Death"

An acquaintance of mine just posted this on a blog:

Treatment of PML

I received this late last week from a prominent University MS clinic.

"Friends: I share this information, received from an investment analyst who says he spoke to the German researcher handling the German PML case:

1. The other case - in Sweden - has practically resolved all PML related symptoms 2. The German case has been treated with mefloquine ( in the last week. All cognitive complaints have resolved since it was initiated, and he is hopeful that all motor signs will resolve as well.

If this is true in both cases, the prognosis for the PML evidencing in a small number of Tysabri treated patients is not a monolithic, tragic kiss of death, but a spectrum of outcomes with the potential for significant recovery."

He goes on to state, "
The concept of PML as a treatable disease is emerging."... we can only and pray that this is the case.

While there is still no illuminating information about the patient's past medical history (the patient in Sweden-case #1), the fact that both patients appear to be doing well, it's very good news indeed!

Just thought I would pass this information on to everyone that is interested.

I almost forgot to mention that I received the an e-mail from, reminding me of the Peer-To-Peer Teleconferences that are scheduled, you may want to make a note of the following dates and times:

August 18th at 8 PM ET
August 21st at 7 PM ET
August 25th at 8 PM ET
August 28th at 10 PM ET
September 4th at 7 PM ET

The e-mail goes on to state in part: "
The panelists will be participating in an open dialogue about how MS has affected their lives and the difference TYSABRI has made for them.

To participate, call 1-866-644-8540 at least 10 minutes before the start of the teleconference. When asked for a code, please say "Peer to Peer Teleconference."

To learn more about upcoming programs, please visit or call Patient Services at 1-800-456-2255."

Have a wonderful rest of the week..., I send you all my very best,


Love, Lauren :)

Wednesday, August 06, 2008

My Tysabri Diary...

I just returned home a little while ago from my 24th Tysabri infusion... nothing new to report other than there was a terrible accident coming home from the infusion center, and having to sit quite awhile in traffic pretty much wiped me out. So I'm going to go to bed early tonight after Ray (my caregiver) returns with the pizza (I'm already sipping my mudslide, yaaay!) <---- laughing.

I asked my infusion nurse if there had been any changes in the number of Tysabri patients they were infusing, if any had dropped out, or if they had added anymore... she said that everything was "status quo", and that all of the patients were doing very well on Tysabri and had absolutely no complaints about the medication (remember, this is a very small infusion center)... she did tell me that she noticed my MS has been stable since I've been going there to receive my Tysabri infusions, so this is a good sign :)

I haven't really checked many of my e-mails because I am really superduper tired, but happy and pleased that I still experience zero side effects from this medication. I can only hope and pray that other patients are loving Tysabri as much as I am.

I am also please to hear that most MS patients & neurologists are not swayed at all by the recent PML reports in the two European Union patients..., it is my understanding that Biogen/Élan (the manufacturer/distributor of Tysabri) is holding approximately 20 different Neurologist Conference Calls through the end of Friday this week to update them regarding the situation, and answer any questions that they might have. I am also please the most of these neurologists (I hear) have not changed their minds at all about Tysabri, and they are still very excited about Tysabri's prospects for their MS patients in need, while they are becoming very aware of the need to continue in their vigilance of observing their patients and monitoring them closely... I don't ever remember my neurologist closely monitoring me when I was on Avonex & then Copaxone... I like being monitored closely, it makes me feel not only safe, but closer to my neurologist :)

Have a great evening everyone,


Love, Lauren :)

Saturday, August 02, 2008

My Tysabri Diary...time for everyone to calm down and take a deep breath...
Damage Control..., I have been receiving e-mails left and right from MS patients currently on Tysabri therapy about the two new cases of PML which were just reported by Biogen/Élan. This news of the two new cases of PML have already hit the MS boards... I'm trying to keep everyone calm until all relevant facts have been disclosed by the companies... it is noteworthy to know that these two patients are not in the US, they are in the European Union where they do not have the Touch protocol... both patients are alive, and one is already home and still ambulatory.

Tysabri is still my drug of choice to treat my MS.

The full details of these two patients prior histories has not been as yet released (i.e., were they already immune compromised before starting Tysabri therapy?)... therefore I would caution everyone to not panic and not read too much into this news until all the facts are known... from what I have been reading, most neurologists are not terribly concerned about these two cases, and the vigilance of the neurologists in the EU has to be extraordinary, considering they don't have the Touch program..., of course, some Tysabri patients will request that go off the therapy as this news is beyond their comfort level for risk vs. benefits, but the majority of MS Tysabri patients will remain intact, with still more MS patients being added weekly:

Read the news for yourself, this is from the FDA's archive files:

On July 31, 2008, Biogen Idec Inc. and Elan Corporation, plc notified relevant regulatory agencies of two confirmed cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients treated with TYSABRI® in the commercial setting. Additional information about these cases is set forth below.

Case 1

· On July 30, 2008, following a period of clinical evaluation, Biogen Idec received confirmation of a diagnosis of PML in an MS patient in the European Union (EU).

· The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.

· As reported to the company on July 31, 2008, the patient remains clinically stable and ambulatory at home.

· Background:

- Patient in EU with aggressive MS who was naïve to prior disease modifying therapy;

- TYSABRI monotherapy for approximately 17 months;

- Clinical vigilance led to early identification of signs and symptoms of possible PML and medical work-up which included MRI scanning and CSF testing, but PML was not confirmed at that time;

- However, given continued clinical suspicion by treating physician, plasma exchange was initiated as outpatient;

- Subsequent testing of CSF detected JCV DNA, which was reported to the company on July 30, 2008;

- It was then determined by PML experts that the latest CSF results, together with the clinical history, physical findings, and MRI results, are consistent with the diagnosis of PML.

Case 2

· On July 31, 2008, Biogen Idec was notified of a diagnosis of PML in a second MS patient in the EU.

· The diagnosis was made based upon the detection of JCV DNA in the CSF in the setting of clinical signs, symptoms, and MRI findings consistent with the diagnosis of PML.

· As reported to the company on July 31, 2008, the patient is currently hospitalized.

· Background:

- Patient in EU with MS with a history of prior disease modifying therapies including azathioprine and beta-interferons;

- TYSABRI monotherapy for approximately 14 months;

- Evaluation for possible PML, included MRI scanning and CSF testing;

- CSF testing detected JCV DNA, which was reported to the company on July 31, 2008;

- The CSF results, together with the clinical history, physical findings, and MRI results, are consistent with the diagnosis of PML.

In closing, let me say that I only hope that some of the above information does help to relieve some of the fears that have been circulating… honestly, IMHO not enough is known about these two patients prior medical histories that would make them susceptible to developing PML. In addition, plasmapheresis has been used on one patient to remove Tysabri from the body, and the other patient is currently receiving plasmapheresis therapy, even though he’s in the hospital.

It is also my hope that those two patients make a full recovery as the due diligence of their neurologists paid off in that they both caught these two cases in early.


Love, Lauren :)