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Auxilium AA4500 Trials Report.
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12/03/2007 18:41
bshatzer 
12/03/2007 18:41
bshatzer 
Re: Auxilium AA4500 Trials Report.

I should add that in the initial trials, PIP joint contracture was somewhat more difficult to treat and more likely to require multiple injections than MP joint contracture. Thus, I suppose I should not be surprised that the first injections of AA4500 proved less than an instant magic bullet with my PIP contracture.

Something to keep in mind for folks in the trials and for Dupuytren patients contemplating AA450 (Xiaflex) treatment after it is released for general use. MP joint contrature seems to respond faster and better to AA4500 (Xiaflex) than does PIP joint contracture. Still, after the full series of injections, the "success" rate seemed to be about the same for both types of contracture - it's just that PIP contracture was more likely to require multiple injections.

(I hope I've got my finger joints correctly identified - before my Dupuytren's developed, I had no idea that finger joints had names!)






12/03/2007 21:03
Randy_H 
12/03/2007 21:03
Randy_H 

PIP Vs MCP

Regardless of the procedure (NA, OS, Collegenase) the PIP will *always* be more difficult than the MCP. It's a much smaller aria to work in and the surrounding tissue tends to conform to the contracture. Once you have a good bend in the PIP, the joint really doesn't want to come back. That's one of the advantages of the noninvasive treatments. You can address the PIP at a much earlier stage and get better results.

If you have a PIP contraction of > 25 degrees, don't wait. Until the approval of Collegenase NA is your only option for early intervention.

12/05/2007 06:37
jocond 
12/05/2007 06:37
jocond 
Re: Auxilium AA4500 Trials Report.

Randy, your absolutley right about the surronding tissue. I just had my first injection last week on my pinky PIP joint. It went from 60 degrees to 20 instantly. Painful and still very tender on the knuckle. My DD started 16 yrs ago in that joint and the skin has shrunk. Between the knuckle swelling and skin contraction it probably would be closer to 0 degrees. I go today for my 7 day follow up. I will say this much,,, it's awesome to be able to put a glove again like normal.

I've known about DD for a long time but never really started researching untill recently. That's when I heard about the Aux. AA4500 trials. This is a dream come true so far. After seeing my dad go thru 5 OS's (2 on one hand and 3 on the other) I've been putting everything off as long as possible. Like I said before mine started 16 years ago. The worst part of all is I'm only 39 yrs old!! I also have two other fingers affected in the MCP's and both of them have nodules. As for Ledderhose, I have that too. But they are currently limited to just nodules. One on the left foot is painful.

Got off track there a little bit, just wanted to explain my situation some. Anyhow I just want to say GO AA4500!!!!!!

12/05/2007 18:49
jocond 
12/05/2007 18:49
jocond 
Re: Auxilium AA4500 Trials Report.

Quote:



Randy, your absolutley right about the surronding tissue. I just had my first injection last week on my pinky PIP joint. It went from 60 degrees to 20 instantly. Painful and still very tender on the knuckle. My DD started 16 yrs ago in that joint and the skin has shrunk. Between the knuckle swelling and skin contraction it probably would be closer to 0 degrees. I go today for my 7 day follow up. I will say this much,,, it's awesome to be able to put a glove again like normal.

I've known about DD for a long time but never really started researching untill recently. That's when I heard about the Aux. AA4500 trials. This is a dream come true so far. After seeing my dad go thru 5 OS's (2 on one hand and 3 on the other) I've been putting everything off as long as possible. Like I said before mine started 16 years ago. The worst part of all is I'm only 39 yrs old!! I also have two other fingers affected in the MCP's and both of them have nodules. As for Ledderhose, I have that too. But they are currently limited to just nodules. One on the left foot is painful.

Got off track there a little bit, just wanted to explain my situation some. Anyhow I just want to say GO AA4500!!!!!!


Just got back from my follow up. My contraction is now at 15 degrees and still very tender. I've been taking my dad with me the last couple of trips and now he set up to receive his first injection next tuesday. He's 75 yrs old turning 76 on the 30th of this month. Yes even with five operations his also returned. He's astounded at what the injection has done my pinky as I am too!!! Can't wait too see how his goes, just hope he doesn't get the placebo.

Joe

12/06/2007 05:36
moondanc 
12/06/2007 05:36
moondanc 
Re: Auxilium AA4500 Trials Report.

bshatzer said:
"Two weeks after my initial injection, there seems to be progress - Yea"

Congratulations on your progress. Are you in a double-blind trial or study drug only? I go for my first injection on Monday in a double-blind so keep your fingers crossed for me. After reading about the bruises, swelling and discloration you guys have faced, I asked the study doc if I could apply ice and was told study regs didn't allow it because ice might interfere with the drug.



12/06/2007 17:16
moondanc 
12/06/2007 17:16
moondanc 
Re: Auxilium AA4500 Trials Report.

I forgot to ask this question. How many days after the injection is it OK to drive --how long does it take before one can easily grip the steering wheel?

thanks.

12/07/2007 04:22
bshatzer 
12/07/2007 04:22
bshatzer 
Re: Auxilium AA4500 Trials Report.

Two week up date. Went to the doctor today to get my splint adjusted. He did a measurement of the of the joint angle.

Drat! Rather than the 30 degree improvement I thought I was seeing, it measures out to a lousy 10 degrees improvement. Still, it IS improvement.

For Moondanc: Driving was no problem for me. I drove home from the physician's office after my initial injections with no serious problems. You might not want to undertake a three-hour drive - more for comfort than anything else - but the 15 to 20 minute drive between the clinic and my house was not a problem. Nor was the return trip the following morning for the follow up appointment.


12/07/2007 19:26
Randy_H 
12/07/2007 19:26
Randy_H 

Re: Auxilium AA4500 Trials Report.

bshatzer,

Did you say that your were in an open study where all the participants get the "real" stuff? A 10 degree improvement could be temporally created from all the stretching and the splitting. If a cord has not been broken though it will not last. Any chance you are getting the placebo?

12/08/2007 03:07
bshatzer 
12/08/2007 03:07
bshatzer 
Re: Auxilium AA4500 Trials Report.

No chance I'm getting the placebo - unless the doctor REALLY messed up.

I'm in the open label study.


12/14/2007 03:05
moondanc 
12/14/2007 03:05
moondanc 
Re: Auxilium AA4500 Trials Report.

I had NA 2.5 years ago for my right hand ring finger MCP joint. It was a piece of cake. However, about 6 months ago the Dupuytren’s returned with a vengeance and progressed to a 35-4-% contracture ( it also appeared in the palm of my left hand and the PIP joint of 2 fingers).
I'm in the Xiaflex Phase III trial and had my first injection on Monday. It's one of the studies where 2/3 receive study med and 1/3 receive a placebo. Luckily, I received the study med. However, I found the injections directly into the cord quite painful--although short-- and the stiffness, bruising and swelling -- 3 days later still existing- quite unpleasant. I had partial "popping" spontaneously overnight but the rest of the procedure to finish the "popping" on Tuesday was extremely unpleasant-- I yelled so loudly, they closed the door. I don't even remember what I did on the second attempt but it was the last one.. My finger straightened to nearly 0%/normal almost immediately but I must stretch it (my study doc recommended sitting on it!) at least 4 times a day to keep it that way. I was also told not to use any ice OR heat on my hand for at least 72 hours so as not to inactivate the collagenase that apparently is still working. Even though my finger is straight, the adhesions/connections in my palm have NOT been released the way they were with NA although the lumps have softened somewhat. The study doc maintains that NA has a 50-70% recurrence rate and that even that number is suspect because no real studies have been done. He also says the recurrence rate with the collagenase is much lower.

As of this moment unless there's a really, really low recurrence rate with collagenase, I'd opt for NA! When I had the NA procedure, I went back to the hotel, napped for an hour and was out shopping with no pain, bruising or other side effects.

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