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Any shared experiences with Xiaflex treatments?
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06/23/2010 21:43
LubaM. 
06/23/2010 21:43
LubaM. 
Re: Any shared experiences with Xiaflex treatments?

@user714:


The FDA’s Division of drug Marketing, Advertising, and Communication cited Auxilium for a brochure that it put out on its drug Xiaflex, which was approved in February for the treatment of a disease that impairs hand function called Dupuytren’s contraction. The letter, dated June 10, said the brochure “broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts.”

Omits material facts? like the fact that NA exists and works better, perhaps?!!!

WOW...If the FDA says that the brochure of Auxillium "broadens the indication for Xiaflex and overstates its efficacy" why did they approve the drug in the first place ?? or am I missing something?

NA does exist and its not perfect (I had NA twice on same finger because of fairly quick recurrence)...but at least its been used over 30
years in France before it was brought to this country 5 yrs. ago, I believe...so there are long term studies about its safety...and its also done in one session, results are immediate, there is practically no pain involved, can be repeated... and its so much cheaper than Xiaflex.

Edited 06/24/10 00:46

06/24/2010 06:21
wach 

Administrator

06/24/2010 06:21
wach 

Administrator

Re: Any shared experiences with Xiaflex treatments?

There isn't much published yet but first data seem to indicate that collagenase has a longer recurrence period than NA.

Annet van Rijssen presented 2010 in Miami data of a 5 year clinical research project comparing recurrence of NA and surgery http://dupuytrensymposium.com/Abstracts/Van_Rijssen.pdf. Recurrence after NA happened on an average after 2.3 years, after fasciectomy on an average after 3.7 years. That's not a big difference but recurrence after NA was much more frequent: after 5 years 85 % of the NA patient had recurrence and only 24 % of the surgeries. These data certainly don't disqualify NA because it's the much easier procedure, has a dramatically faster recovery, and it doesn't trigger extension into other areas.

The comparison with collagenase hasn't been done yet but from stories told at the conference my guess is that it roughly combines advantages of both treatments: a simple procedure with a recurrence more like surgery, i.e. much better than NA. Now that doesn't tell anything about side effects of collagenase and we will need experience with many more treatments and longer periods of observation than were in the trials to understand and measure side effects.

Wolfgang

06/24/2010 16:09
Mike S

not registered

06/24/2010 16:09
Mike S

not registered

Re: Any shared experiences with Xiaflex treatments?

To me the biggest disadvantages of Xiaflex as compared to NA are

1. Much higher cost
2. Reportedly requires two (or even three?) interventions - i.e. more time, more worry/fear, etc.

06/24/2010 16:13
LubaM. 
06/24/2010 16:13
LubaM. 
Re: Any shared experiences with Xiaflex treatments?

Wolfgang, thank you for your explanation. As you point out, there definitely seem to be data on side by side comparison of NA versus surgery and recurrence is, unfortunately, higher in NA.

On a personal note...I had NA twice on same finger and spent many months (both times) at occupational hand therapy, and having seen many patients come in to do hand therapy after surgery, I will avoid surgery at all cost after seeing these patients, in spite of the lesser recurrence rate....I would rather repeat NA as needed because of the ease of the procedure, faster recovery and possibility of repeating as needed. However, when collagenase's long term effects are proven to be successful, I will definitely consider it as well.

06/24/2010 18:42
wach 

Administrator

06/24/2010 18:42
wach 

Administrator

Re: Any shared experiences with Xiaflex treatments?

I can relate to that. Unfortunately there are no conclusive data available on the effect of splinting. In Miami one paper reported no measurable effect of splinting (but to my opinion they looked at the wrong, i.e. insensitive measurements) and another paper showed positive effects of splinting after NA. Personally I believe in splinting and use it even preventively. I also believe -without being able to prove it scientifically - that splinting can push out recurrence. The published Dutch comparison of NA and surgery did not take into account the effect of splinting.

Wolfgang

LubaM.:
...On a personal note...I had NA twice on same finger and spent many months (both times) at occupational hand therapy, and having seen many patients come in to do hand therapy after surgery, I will avoid surgery at all cost after seeing these patients, in spite of the lesser recurrence rate....I would rather repeat NA as needed because of the ease of the procedure, faster recovery and possibility of repeating as needed. However, when collagenase's long term effects are proven to be successful, I will definitely consider it as well.

06/24/2010 20:20
guest

not registered

06/24/2010 20:20
guest

not registered

Re: Any shared experiences with Xiaflex treatments?

wach:
There isn't much published yet but first data seem to indicate that collagenase has a longer recurrence period than NA.



The comparison with collagenase hasn't been done yet but from stories told at the conference my guess is that it roughly combines advantages of both treatments: a simple procedure with a recurrence more like surgery, i.e. much better than NA. Now that doesn't tell anything about side effects of collagenase and we will need experience with many more treatments and longer periods of observation than were in the trials to understand and measure side effects.

Wolfgang

I'm very curious about who shared the stories--other than researchers in the Dups study--and supposedly there hasn't been a clinical double bind study although I believe someone posted something last week about recurrence rates. Based on my experience with the researchers--the study was very, very inexact and sloppy with measurements and no way to control other procedures such as NA subsequent to Xiaflex. So if someone had successful NA after a Xiaflex failure, it's counted as a Xiaflex success!

06/25/2010 12:29
jocond 
06/25/2010 12:29
jocond 
Re: Any shared experiences with Xiaflex treatments?

I'm very curious about who shared the stories--other than researchers in the Dups study--and supposedly there hasn't been a clinical double bind study although I believe someone posted something last week about recurrence rates. Based on my experience with the researchers--the study was very, very inexact and sloppy with measurements and no way to control other procedures such as NA subsequent to Xiaflex. So if someone had successful NA after a Xiaflex failure, it's counted as a Xiaflex success!



Guest,

What double blind study are you referring to?

06/25/2010 14:19
LubaM. 
06/25/2010 14:19
LubaM. 
Re: Any shared experiences with Xiaflex treatments?

deggleston:
I understand Xiaflex was approved by FDA back in Feb of this year
I've had two treatments so far, and its helping. The pain associated with the cord breakage was the worst part.

It was my understanding that during the trials they were not allowed to give numbing medication, but it would be given once the xiaflex was released outside of the trials... Deggleston, were you given medication? why was there so much pain?

Edited 06/25/10 17:21

06/25/2010 23:11
guest

not registered

06/25/2010 23:11
guest

not registered

Re: Any shared experiences with Xiaflex treatments?

jocond:
I'm very curious about who shared the stories--other than researchers in the Dups study--and supposedly there hasn't been a clinical double bind study although I believe someone posted something last week about recurrence rates. Based on my experience with the researchers--the study was very, very inexact and sloppy with measurements and no way to control other procedures such as NA subsequent to Xiaflex. So if someone had successful NA after a Xiaflex failure, it's counted as a Xiaflex success!



Guest,

What double blind study are you referring to?


I said as far as I know there hasn't been a double-blind study of recurrence rates for Xiaflex. I thought I saw a post here sometime in the last couple weeks that referenced a "study" --with few details--that mentioned "good" recurrence rates. They are currently doing yearly visits with interviews and questionnaires and blood tests in an attempt to measure recurrence rates among study participants.

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