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Xiaflex follow up research
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12/31/2009 00:05
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12/31/2009 00:05
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Xiaflex follow up research

Auxilium , the maker of the collagenase (Xiaflex), is probably going to be doing a follow up research study to better understand the nature of Dupuytren's disease and the rate of recurrence in joints treated with Xiaflex. The study consists of 1 visit per year for the next 4 years . They will be taking finger measurements of both hands and monitoring blood for antibodies to the collagenase.

Wonder what this means in regard to FDA approval?

12/31/2009 02:15
AUSSIE 1

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12/31/2009 02:15
AUSSIE 1

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Re: Xiaflex follow up research

I thought I would add a comment from an hand/upper limb surgeon."The injections are not good at all. I think it cannot be repeated and surgery performed after the injections is more difficult due to the changes in the peri-neural fat, which makes dissection of the nerve more difficult."

01/01/2010 00:19
jimh 
01/01/2010 00:19
jimh 
Re: Xiaflex follow up research

Aussie, do you know if that surgeon was speaking from first hand experience in the Xiaflex trials? If so, those statements are discouraging. However it seems many surgeons are anxious to discount Xiaflex and NA without actually knowing much about them.

01/01/2010 02:19
AUSSIE 1

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01/01/2010 02:19
AUSSIE 1

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Re: Xiaflex follow up research

I know that this surgeon does carry out NA on about 50% of his patients in a large teaching hospital. I can only state what his comment was about the injections. I know he is not too keen on Radiotherapy either even though he has seen my hands. Time will tell if hang around long enough.

01/02/2010 03:07
tgrunde 
01/02/2010 03:07
tgrunde 
Re: Xiaflex follow up research

I had surgery at 48 - about three years ago, it came back, and I did the Xiaflex clinical trial with better results - so far. I'm signed up for the follow-up study and get my first measurements Tuesday January 5, 2010. I need one more good injection and snap on my left little finger once FDA approves (in 3 or 4 months I hope) - but I expect I'll have recurring problems forever. Better this than a lot of other diseases.

01/03/2010 20:11
flojo 
01/03/2010 20:11
flojo 
Re: Xiaflex follow up research

tgrunde,

Check out radiation therapy to prevent progression of Dupuytren's Disease. Look at the information under Radiation therapy in the left column.

01/13/2010 02:07
moondanc 
01/13/2010 02:07
moondanc 
Re: Xiaflex follow up research

Wonder what this means, especially now that we are reading about more long-term follow up with Auxillium and Xiaflex

http://www.evaluatepharma.com/Universal/...isEPVantage=yes

"However, while some analysts are bullish about the drug's chances of shifting its approval hearing from December to August, there are others who believe that ****niggling concerns over hypersensitivity, which have started to envelop the injection, ****could mean the US regulator will take both a more cautious stance and its time in deciding to grant approval.

"hypersensitivity, which have started to envelop the injection"-- can someone translate that into English for me?

03/17/2010 18:33
kelleym

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03/17/2010 18:33
kelleym

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Re: Xiaflex follow up research

I am pleased to find this site; yesterday I read about Xiaflex and am relieved to know surgery may not be necessary. I don't have major contractures, however the nodules in both of my palms continue to grow and the number of them is increasing. A question I have is: when will I know it is time for treatment?

03/17/2010 18:38
mike59 
03/17/2010 18:38
mike59 
Re: Xiaflex follow up research

Good question Kelley.

03/18/2010 02:21
flojo 
03/18/2010 02:21
flojo 
Re: Xiaflex follow up research

Kelley,
I would suggest that you consider radiation therapy, RT, before you get contracture. Read about it on the links on the left side of this page. It has been effective in stopping the progression in my palm. My whole palm was treated with RT. It is most effective in the early stages and when Dupuytren's is active.

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evaluatepharma   emphatically   circumstances   Xiaflex   surgery   injection   isEPVantage=yes   information   aponeurotomy   questionnaires   measurements   progression   surgeon   Dupuytren   contractures   radiation   injections   research   hypersensitivity   collagenase