Mandatory Rest Period

Eek. This is not something I wanted to see. Taking drug holidays is something new to my thinking but my doctor mentioned it the other day when I was at the clinic. Interesting. What a balance that would entail.

"The popular multiple sclerosis drug Tysabri appears to promote a rare brain infection by suppressing immune system cells in the brain, researchers said on Tuesday.

The researchers, who conducted an autopsy on an MS patient who died while taking the drug, said it may be possible to make the drug safer by giving patients treatment "holidays" from time to time to allow the brain's immune protection to recover.

Tysabri, known generically as natalizumab and made by Biogen Idec Inc (BIIB.O) and Elan Corp (ELN.I)(ELN.N) of Ireland, can cause a serious brain infection called progressive multifocal leukoencephalopathy or PML.

It was pulled off the market soon after being introduced in 2004, but sold again beginning in 2006 because there were few good options for patients with MS.

On Monday Biogen reported the fourth case of PML this year -- in a European patient who had been taking Tysabri exclusively for 26 months.

"Whether or not treatments other than prolonged, uninterrupted dosing may benefit patients with MS should be tested in controlled clinical trials," Dr. Olaf Stuve, a neurologist at the University of Texas Southwestern Medical School in Dallas, said in a statement.

Tysabri's package insert label cautions that patients taking the drug have a 1-in-1,000 risk of developing PML.

Writing in the Archives of Neurology, Stuve and colleagues said they found significantly fewer immune cells called CD4 T cells in and around the patient's blood vessels in the brain.

"Natalizumab is very effective in keeping pro-inflammatory cells out of the brain to reduce damage from MS," Stuve said in a statement. But by doing so it may promote infection in some people.

Stuve said doctors should look for biomarkers -- easily tested indicators -- in people who may be developing the syndrome so they may be taken off the drug.

"It's a very effective drug, and it's clear that the vast majority of patients are greatly benefiting from its use," Stuve said. He said about 43,000 people had taken natalizumab since 2006."

- posted by Anonymous @ 10:28 AM - Link @ 10:28 AM - Link to this post - Comments (0)

Wednesday, December 17, 2008
It's snowing!

My favourite thing! When it snows here, we all don't know how to deal with it. Lots of folks work from home etc. but I drove in to work and love looking out my window to see it falling! I want to go skiing! Hey, with how well my health has been lately, I'm going to go skiing this year! It's been almost 10 years since I went skiing! I'll let you know how that goes :) And now, a little nice warm sunset from Kona while the snow coniues to fall!

- posted by Anonymous @ 10:31 AM - Link @ 10:31 AM - Link to this post - Comments (0)

Fingolimod (FTY720) news!

Well, here's the latest results from the Transforms clinical trial I started on and finished 6 months ago! Great news and it looks like all is moving forward with going to regulatory approvals. I'm still on the drug and still no relapses a year and half later! I went for my latest check in yesterday and all is the same. I did get to see my white blood cell count which was finally unblinded to me now that I'm on the extention phase of the trial. I'm certainly lower than normal people so perhaps thats why I still haven't kicked this darn cold!

"Initial results from the one-year Phase III TRANSFORMS study show the investigational oral compound FTY720 (fingolimod) has superior efficacy to a current standard of care for patients with relapsing-remitting multiple sclerosis (MS). Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex®*)[1]. The study, the first one-year head-to-head Phase III trial against a standard of care in MS, met its primary endpoint for both doses of FTY720.

The annualized relapse rate at one year for patients given FTY720 0.5 mg was 0.16, representing a 52% reduction compared to a relapse rate of 0.33 for interferon beta-1a (p<0.001). The FTY720 1.25 mg dose also showed a significant reduction in relapses with a rate of 0.20 representing a 38% reduction against interferon beta-1a (p<0.001). No statistically significant difference was seen between the two FTY720 doses[1].

Comprehensive analyses of the TRANSFORMS study data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2009. Regulatory submissions remain on track to be completed in the US and EU at the end of 2009."

- posted by Anonymous @ 10:23 AM - Link @ 10:23 AM - Link to this post - Comments (0)

Friday, December 12, 2008
Home Sweet Home

First a couple pictures :) Here's my new BFF.

And the amazing ocean!

Great view from the suite.

Sadly I caught a wicked cold on the plane ride down and am still trying to kick it before Christmas is here. I'm pretty stunned at getting a cold like this one. I never have a cold for this long! What the heck is my immune system up to!?

- posted by Anonymous @ 12:51 PM - Link @ 12:51 PM - Link to this post - Comments (0)

			Hi, I’m Kim! This site provides a little insight to my journey of being diagnosised with Remitting Relapsing Multiple Sclerosis on October 26th 2004. I review books and documentaries, post MS-related news, and share my photos. Subscribe (RSS) My bloglines Archives Current November 2004 December 2004 January 2005 February 2005 March 2005 April 2005 May 2005 June 2005 July 2005 August 2005 September 2005 October 2005 November 2005 December 2005 January 2006 February 2006 March 2006 April 2006 May 2006 June 2006 July 2006 August 2006 September 2006 October 2006 November 2006 December 2006 January 2007 February 2007 March 2007 April 2007 May 2007 June 2007 July 2007 August 2007 September 2007 October 2007 November 2007 December 2007 January 2008 February 2008 March 2008 April 2008 May 2008 June 2008 July 2008 August 2008 September 2008 October 2008 November 2008 December 2008 January 2009 February 2009 March 2009 April 2009 May 2009 June 2009 July 2009 August 2009 September 2009 October 2009 November 2009 December 2009 January 2010 February 2010 March 2010 May 2010 June 2010 July 2010 September 2010 November 2011

	Tuesday, December 23, 2008 *More snow coming!* Holy smokes! I could have a white christmas! That never happens! 20 to 30cms is coming tonight and tomorrow! - posted by Anonymous @ 10:34 AM - Link @ 10:34 AM - Link to this post - Comments (0) *MS drug Tysabri may promote brain infection-study* Eek. This is not something I wanted to see. Taking drug holidays is something new to my thinking but my doctor mentioned it the other day when I was at the clinic. Interesting. What a balance that would entail. "The popular multiple sclerosis drug Tysabri appears to promote a rare brain infection by suppressing immune system cells in the brain, researchers said on Tuesday. The researchers, who conducted an autopsy on an MS patient who died while taking the drug, said it may be possible to make the drug safer by giving patients treatment "holidays" from time to time to allow the brain's immune protection to recover. Tysabri, known generically as natalizumab and made by Biogen Idec Inc (BIIB.O) and Elan Corp (ELN.I)(ELN.N) of Ireland, can cause a serious brain infection called progressive multifocal leukoencephalopathy or PML. It was pulled off the market soon after being introduced in 2004, but sold again beginning in 2006 because there were few good options for patients with MS. On Monday Biogen reported the fourth case of PML this year -- in a European patient who had been taking Tysabri exclusively for 26 months. "Whether or not treatments other than prolonged, uninterrupted dosing may benefit patients with MS should be tested in controlled clinical trials," Dr. Olaf Stuve, a neurologist at the University of Texas Southwestern Medical School in Dallas, said in a statement. Tysabri's package insert label cautions that patients taking the drug have a 1-in-1,000 risk of developing PML. Writing in the Archives of Neurology, Stuve and colleagues said they found significantly fewer immune cells called CD4 T cells in and around the patient's blood vessels in the brain. "Natalizumab is very effective in keeping pro-inflammatory cells out of the brain to reduce damage from MS," Stuve said in a statement. But by doing so it may promote infection in some people. Stuve said doctors should look for biomarkers -- easily tested indicators -- in people who may be developing the syndrome so they may be taken off the drug. "It's a very effective drug, and it's clear that the vast majority of patients are greatly benefiting from its use," Stuve said. He said about 43,000 people had taken natalizumab since 2006." - posted by Anonymous @ 10:28 AM - Link @ 10:28 AM - Link to this post - Comments (0) Wednesday, December 17, 2008 *It's snowing!* My favourite thing! When it snows here, we all don't know how to deal with it. Lots of folks work from home etc. but I drove in to work and love looking out my window to see it falling! I want to go skiing! Hey, with how well my health has been lately, I'm going to go skiing this year! It's been almost 10 years since I went skiing! I'll let you know how that goes :) And now, a little nice warm sunset from Kona while the snow coniues to fall! - posted by Anonymous @ 10:31 AM - Link @ 10:31 AM - Link to this post - Comments (0) *Fingolimod (FTY720) news!* Well, here's the latest results from the Transforms clinical trial I started on and finished 6 months ago! Great news and it looks like all is moving forward with going to regulatory approvals. I'm still on the drug and still no relapses a year and half later! I went for my latest check in yesterday and all is the same. I did get to see my white blood cell count which was finally unblinded to me now that I'm on the extention phase of the trial. I'm certainly lower than normal people so perhaps thats why I still haven't kicked this darn cold! "Initial results from the one-year Phase III TRANSFORMS study show the investigational oral compound FTY720 (fingolimod) has superior efficacy to a current standard of care for patients with relapsing-remitting multiple sclerosis (MS). Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex®)[1]. The study, the first one-year head-to-head Phase III trial against a standard of care in MS, met its primary endpoint for both doses of FTY720. The annualized relapse rate at one year for patients given FTY720 0.5 mg was 0.16, representing a 52% reduction compared to a relapse rate of 0.33 for interferon beta-1a (p<0.001). The FTY720 1.25 mg dose also showed a significant reduction in relapses with a rate of 0.20 representing a 38% reduction against interferon beta-1a (p<0.001). No statistically significant difference was seen between the two FTY720 doses[1]. Comprehensive analyses of the TRANSFORMS study data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2009. Regulatory submissions remain on track to be completed in the US and EU at the end of 2009." - posted by Anonymous @ 10:23 AM - Link @ 10:23 AM - Link to this post - Comments (0) Friday, December 12, 2008* *Home Sweet Home* First a couple pictures :) Here's my new BFF. And the amazing ocean! Great view from the suite. Sadly I caught a wicked cold on the plane ride down and am still trying to kick it before Christmas is here. I'm pretty stunned at getting a cold like this one. I never have a cold for this long! What the heck is my immune system up to!? - posted by Anonymous @ 12:51 PM - Link @ 12:51 PM - Link to this post - Comments (0)