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Therapy Reoccurrence Information
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05/13/11 16:31
way

not registered

05/13/11 16:31
way

not registered

Therapy Reoccurrence Information

Is there a place where I can find reoccurrence information for surgery and needle treatment? I called the company that makes Xiaflex and was told they found 20 degree recontraction in 6.7% of cases based on the first year of data.

05/16/11 07:38
wach 

Administrator

05/16/11 07:38
wach 

Administrator

Re: Therapy Reoccurrence Information

Unfortunately there is no standard definition of recurrence and how to measure it. Therefore data are reported in all sort of intervalls and the definition of recurrence varies widely (http://www.dupuytren-online.info/dupuytr...techniques.html). A famous statement is that recurrence is always 100% if you wait long enough. Instead of reporting how much recurrence was observed after x years it would be better to measure average recurrence intervalls but that would require longer observation and most clinics don't have those data. You would have to investigate all patients treated in the last 10 years or so and nobody would pay for that effort.

Recurrence for collageanse injection is still being investigated. For the time being there are only a few data from patients from the trials. It might take a while before enough patients have been treated and tracked long enough. The hope is that collagenase, because dissolving some of the cord, might have a better recurrence than NA. Time will tell.

Wolfgang

05/16/11 19:14
wach 

Administrator

05/16/11 19:14
wach 

Administrator

Re: Therapy Reoccurrence Information

Hi, I forgot to mention a recent review paper on fasciotomy (=NA) and fasciectomy (=surgery):

Crean et al. "The efficacy and safety of fasciectomy and fasciotomy for Dupuytren's contracture in European patients: a structured review of published studies." J Hand Surg Eur Vol. 2011 Mar 7. [Epub ahead of print]

Abstract: http://www.ncbi.nlm.nih.gov/pubmed/21382860

With regard to recurrence after 4 years the results are roughly:
60 % recurrence with NA
40 % recurrence with surgery.

Wolfgang

07/13/11 01:32
bstenman 
07/13/11 01:32
bstenman 
Re: Therapy Reoccurrence Information

I believe it is important to view both recurrence rates and risks with different approaches. Risk of serious complications is 6x greater with a standard fasciectomy when compared to NA which should not be surprising considering the nature of the two procedures.

NA is being applied in a somewhat uniform manner from doctor to doctor but that is not the case with Xiaflex. The initial study groups had different amounts applied than is currently the case and some people get one set of injections and others with deeper pockets get multiple series of injections so the results are going to be all over the map in the years ahead with these variables not being controlled or monitored.

In my own case my Blue Cross insurance would only cover the first vial of Xiaflex and though my doctor agreed that a second vial would be beneficial to remove the remaining contracture and was FDA approved, I did not want to pay the additional $4700 involved to have this done. I have already paid more than $4000 in out of pocket medical expenses after paying more than $700 a month for my medical insurance coverage. It is unfortunate that the production of Xiaflex was licensed by it German company creator to a US company which is now gouging patients as only American companies can.

This is going to greatly skew the results as the treatment is not going to be uniformly applied among patients so there is going to be a biased sampling of people with Dupuytren's. There has also been no followup by the US company that produces and sells Xiaflex and no uniform effort to scientifically collect the necessary data, only anecdotal information from forums such as this.

07/13/11 18:29
Larry 
07/13/11 18:29
Larry 
Re: Reoccurrence ... Definition

I think its clear :

reoccurrence means at least NEW DISEASE after DISAPPEARANCE or after previous REMISSION; that could be:

(1) NEW NODULES or Increasing Size of Nodules

(2) NEW CORDS or Increasing EXtension of Cors

(3) INCREASED FUNCTION DEFICIT, e.g. angulation of one or more fingers

(4) INCREASED SYMPTOMS which could be measured by a Visual Analogous Scale (VAS)

or any other aspect considered as subjective worsening / quality of life.


Best regards, Larry

07/14/11 23:05
bstenman 
07/14/11 23:05
bstenman 
Re: Therapy Reoccurrence Information

In the USA the medical insurance providers are only covering the cost of Xiaflex when the contraction is caused by a cord and the FDA approval is also only for this type of use. Treatment of nodules unless they directly restrict the range of motion of joints is not going to be covered. With my own Empire Blue Cross coverage the restriction needs to be 30 degrees or more for the MP joint and 20 degrees or more at the PIP joint to qualify for reimbursement.

In the very small (in terms of the number of participants) clinical trials injections were at times re-administered after a four week interval. My insurance carrier only covers the cost of the first vial for treatment and not for subsequent vials regardless of the need. I expect that this is true for many others receiving the Xiaflex treatment and so they are not always going to get a full and complete treatment of the cord. This creates a serious level of bias in the results when one set of individuals receives multiple vials with multiple treatment sessions and another set of individuals receives only one vial in one treatment session.

In my case, 4 months after receiving a single Xiaflex treatment my contracture is now at 50% of what it was prior to the treatment. In terms of overall effectiveness as the treatment is currently being provided I view it as being much less effective than NA. The doctor, who performs many NA and Xiaflex procedures each year, and who performed a NA on the same area of my primary hand in 2007, recommended Xiaflex as being safer in terms of chance for nerve damage and I followed his advice. Next time I will definitely go with NA instead.

I have participated in two patient surveys since that time and both were poorly designed and whatever data they collected was not going to be scientifically valid. Any data collected by Auxilium is going to either not be released or released only to the extent that it favors the use of their product.

If only for these reasons accurate information on therapy recurrence with regard to Xiaflex is going to be suspect and remain so until a scientific and unbiased study is done on the patients receiving the treatment and the information is released to the public.

07/15/11 16:55
Larry 
07/15/11 16:55
Larry 
Re: Therapy Reoccurrence Information - Details of Documentation

bstenman:
In the USA the medical insurance providers are only covering the cost of Xiaflex ....

If only for these reasons accurate information on therapy recurrence with regard to Xiaflex is going to be suspect and remain so until a scientific and unbiased study is done on the patients receiving the treatment and the information is released to the public.


This does not sound very good and I would be interested to know more about the type of documentation they perforemd during the trial, as I was really amazed about the special effort of detailed documentation done by Prof. Seegenschmiedt, formerly in Essen , now in Hamburg, before he started his treatment. I am able to pull my photocopies from that time and compare it to my present situation - I can read every nodule and cord then and now and I can interpret my symptoms then and now, so lon-term evaluation was never a problem in the RADIOTHERAPY TRIAL in GERMANY. I am called by telephone about every 1 - 2 years and asked for my condition or I show up when I have a change ...

So pleas provide further information on the type of documentation which is performed by AUXILIUM when using Xiaflex.

Thanks in advance, LARRY

07/18/11 18:04
wach 

Administrator

07/18/11 18:04
wach 

Administrator

Re: Therapy Reoccurrence Information

If I may voice my personal opinion:

The key authors of the Xiaflex trials, Larry Hurst and Marie Badalamente, are very thorugh scientists and to my opinion their results are trustworthy and well documented. But they have not yet published statistically reliable, long term data about recurrence of collagenase. The patients of the phase I trial were probably carefully selected (I would have done that to not skew the results from the very beginning). Therefore their results with regard to recurrence might not be typical. Later phases of the trial showed increasingly less efficiency of the procedure per se and they might (just might!) also exhibit a shorter recurrence period. Time will tell because now an increasing number of patients is being treated with collagenase.

The patient studies where bstenman participated in may have been studies from marketing agency. I agree with bstenman and wouldn't trust those either. Not that they are lying but maybe delivering the results that they believe their customer wanted to see. I don't think a marketing study has any scientific value.

If the studies that bstenman is mentioning would have be part of the actual trial then this would a much bigger issue. But don't think so.

Wolfgang

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