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Xiaflex information
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03/23/2010 01:50
moondanc 
03/23/2010 01:50
moondanc 
Xiaflex information

I had my first appointment for the followup study requested by the FDA for subjects in the most recent/final Xiaflex trials. Here are some of the things I was told:

1. There has never been a formal followup on any Xiaflex subjects longer than the 10-12 months in the last FDA trial and the FDA is now requesting 4 years followup data
2. The $3250 wholesale cost for Xiaflex provides material for only one injection (the trial itself gave a minimum of 3 injections--on the same day--into the cord)
3. Auxilium expects that Medicare and private insurance companies will cover 80% of the cost
4. Stanford already has 25 patients signed up for Xiaflex injections and expects to begin them in 4-6 weeks

Information required at this visit, in addition to a blood test:
1. All medications being taken and why
2. All medical procedures occuring since 12/07
3. Measurements of fingers on both hands and visual inspection of the palms

In my case, since I've had RT & 2 NA treatments on the study finger and palm, the measurements are virtually useless in determining how long Xiaflex lasts. Based on the way the study questions were asked, I don't have a lot of confidence that my case will be considered a failure. Last week I found out that my dental implants--two-- which I've had for 9 years without a problem are failing and will have to be removed. I tried to report this but since the removal surgery has not yet occurred, it will have to wait for next year although it won't really be next year, it will be November, 210 because they're trying to get back on a yearly schedule (since 12/2007).
Diane (Moondanc)




03/23/2010 01:54
moondanc 
03/23/2010 01:54
moondanc 
Re: Xiaflex information

SandyB posted the message below on my guestbook (I didn't even know there was such a feature on this site!)--she thought she was posting it to the site--and has given me permission to post it for her:

"I participated in the FDA study and also think the drug actually accelerates the growth/expansion of the disease. After 3 injections in the PIP, there was no release. I've since had surgery. The surgeon said the disease was unusually extensive. Some of it could have been scar tissue, but the surgery took 3x longer than usual. I have DC in my other hand, have had one NA although the PIP did not release I will not consider using Xiaflex. I would guess that the successes with this new drug are most common for the MCP release rather than the PIP."

Diane

04/02/2010 14:25
SandyB 
04/02/2010 14:25
SandyB 
Re: Xiaflex information

My left hand is now affected with DC; palm and ring finger. I had NA performed about 6 months ago by Dr. Eaton. My problem is in the PIP. The DC is currently active and the knuckle is sore. Its about 15% contracted. The extensive surgery performed on my right hand as a result of NA in the palm and MCP of small finger (twice) and Xiaflex in the MCP of small finger and the lapse of time waiting for the trials to begin has permanently damaged my little finger PIP and the overall dexterity of my right hand.

Is there anyone out there that has experienced success with ANY procedure done to an infected PIP? Has anyone received Xiaflex in the PIP? I fear further aggravation to the fascia with any procedure including NA. However, I must investigate my options (if any) to avoid permanent damage to my ring finger PIP.

Any comments or advice would be greatly appreciated!

Sandy

04/02/2010 17:04
flojo 
04/02/2010 17:04
flojo 
Re: Xiaflex information

It sounds like your Dupuytren's is active. Have you considered radiation therapy as an option for you? It has been effective in stopping or slowing the progression of Dupuytren's for some of us who got RT when the Dupuytren's was active. They say that it is key for Dups to be active for RT to be most effective. RT doesn't help with already existing contracture.

04/06/2010 17:06
BobN 
04/06/2010 17:06
BobN 
Re: Xiaflex information

I've had 3 NA procedures and all were out-of-pocket expenses. The third NA was on the PIP joint of the pinky. Not an easy task even for one of the best hand doctors. The Dups was so intermingled with the nerves that he had to stop and the finger was not straightened - only the MPJ was released and the remaining nerve damage made the pinky feel somewhat numb in certain areas. I don't think Xiaflex would have done any better without significantly affecting the nerves and blood vessels.

A year later the same pinky was more than 90 degrees bent at the PIP and I went to a local CHS with Plastics and microsurgery qualifications. I asked for a partial or segmented fasciotomy knowing that open surgery would inflict a lot of collateral damage. He insisted that OS is the only option. Because NA failed, I felt making another attempt at $1500 out-of-pocket expenses was an unreasonable financial risk, I went for the OS hoping that his plastics and microsurgery credentials would improve my odds of a good outcome.

Bad judgment on my part. After 6 months of healing and therapy, my pinky and palm are full of scar tissue and nerve damage is worse. The pinky is straighter - about 20 degrees bent, but is still swollen if I don't use a compression sleeve all the time. I can't close it fully either. It has much larger numb areas and the feeling it does have feels like little stabs or like I'm touching freezing metal when it touches anything. A little known side effect is the flare of carpal tunnel syndrome from the swelling - which I now have to consider yet more surgery.

Going forward with this disease, I would like to see/hear the medical community considering segmented releases simply because we all want to straighten out fingers, but not at the cost of all the damage that OS brings - especially when it is in the fingers. Let's face it, until there is a gene therapy for this disease, there is no cure and surgery is not going to cure it. I would prefer to manage it than believe removal of the fascia is the ONLY medically approved approach.

I think Xiaflex may be useful in managing the disease by scheduled maintenance injections into the chords and lumps in the palms letting the body reabsorb the collagen that binds us and bends our fingers. A slower release over time should result without having to endure the painful tearing of the weakened chord.

I don't ever plan on OS again - the personal cost is too great considering that my hand will never be better than when the finger was bent. I just wanted the pinky straightened, but now my once skillful hand is very difficult to manipulate tools and such - like they used to before OS.

My two cents.

04/06/2010 17:53
SandyB 
04/06/2010 17:53
SandyB 
Re: Xiaflex information

My experience mimics yours. Surgery cleaned my right hand of the disease. I have piece of mind that its gone, but continue to second guess myself. Surgery was encouraged, but, its not always the best. Surgeons are very intrigued with DC and want as much experience with it as offered to them. (Think surgeons on Gray's Anatomy!)

My experiences tell me that when the PIP is infected, the patient is at the mercy of the disease. Xiaflex and NA aggravate the fascia. I believe that is fairly well documented. Surgery, if successful, leaves scarring, nerve issues, tendon issues and often deformities. I currently seeking a physician that will refer me to a radiologist; so far no go. That's the only treatment I've not used!

In the meantime, I try to avoid large consumptions of sugar and alcohol (hard to do!) and trama to the hand (gripping as in carrying heavy suitcase or hanging from a bar in the gym).

Keep the PIP experiences coming!
SandyB

04/06/2010 19:16
moondanc 
04/06/2010 19:16
moondanc 
Re: Xiaflex information

Quote:



In the meantime, I try to avoid large consumptions of sugar and alcohol (hard to do!) and trama to the hand (gripping as in carrying heavy suitcase or hanging from a bar in the gym).

Keep the PIP experiences coming!
SandyB



I have that sugar and alcohol AND gym--dumbell lifting--problem myself! Maybe some day they'll start recommending PIP joint replacements--which they now do for rheumatoid arthritis-- for DD affected PIP joints.

You mentioned seeking a physician for a recommendation for RT. Is that because your insurance demands that? I went directly (Medicare) to the radiation oncologist with no recommendation needed-come to think of it, perhaps that's why Medicare isn't paying it (although when the physician org. asked Medicare--before the RT--whether it was covered Medicare said yes). I'm curious whether others who have haed RT needed a physician recommendation first.
Diane

Edited 04/06/10 22:20

04/06/2010 19:37
moondanc 
04/06/2010 19:37
moondanc 
Re: Xiaflex information

Quote:




I think Xiaflex may be useful in managing the disease by scheduled maintenance injections into the chords and lumps in the palms letting the body reabsorb the collagen that binds us and bends our fingers. A slower release over time should result without having to endure the painful tearing of the weakened chord.

I don't ever plan on OS again - the personal cost is too great considering that my hand will never be better than when the finger was bent. I just wanted the pinky straightened, but now my once skillful hand is very difficult to manipulate tools and such - like they used to before OS.

My two cents.




Bob--
I'm really sorry to hear about your negative outcomes with NA and especially with OS. I would like to comment on what you have said about Xiaflex. There are NO long-term clinical studies to demonstrate the longevity of Xiaflex--None--and that's why the FDA is requiring--after they approved it, go figure--it be done now. There's a four year trial with yearly interviews of patients who received Xiaflex injections in the Stage 3 clinical trials. There are NO long term studies with regard to the potential long-term side effects of Xiaflex. Does it affect the immune system long term? Does it make DD worse? Does it affect other tissues, etc. The final Stage 3 trial only followed patients for 11-12 months. My Xiaflex injection/release lasted only 14 months before it was right back where it began. I've talked to three or four other people in the trials who had the same experience. What is the evidence that Xiaflex is any better long-term than NA? Why do people think it would be? Perhaps it is possible to inject Xiaflex into places inaccessible to NA but wouldn't that also subject those nerves and tendons to the enzyme and consequent damage? There were tendon ruptures reported in the FDA trials. Finally, as far as I know, there have been NO studies where Xiaflex was injected into nodules. I have no idea if that's a recommended use. I'd be very, very, very careful of Xiaflex until there are some long-term studies--longer than 1 year--demonstrating its safety, efficacy and longevity.

Best,
Diane/Moondanc

04/07/2010 06:18
wach 

Administrator

04/07/2010 06:18
wach 

Administrator

Managing Dupuytren's

Diane and Bob:

Wearing a night splint to pervent further contracture might be another option. If the splint is confortable and easy to mount/dismount than it's not a big deal wearing it. I am using it myself and feel that it does help keeping my pinkie (somewhat) straight.

Diane, a first long term study of Xiaflex was published recently. Not very many cases tracked, for obvious reasons, and not very definite on recurrence but still a start:
Watt AJ, Curtin CM, Hentz VR "Collagenase injection as nonsurgical treatment of dupuytren's disease: 8-year follow-up." J Hand Surg Am. 35 (2010) p 534-9 http://www.ncbi.nlm.nih.gov/pubmed/20353858

Wolfgang

04/07/2010 12:09
BobN 
04/07/2010 12:09
BobN 
Re: Xiaflex information

Hi Wolfgang,

I do wear a night splint to keep the scar tissue from further contracting. It is the scar tissue that is deforming my finger now. I believe the DD is removed fully from the finger, but the Dr did comment that there was no recurrence yet - implying that it could still happen. The splint will wake me up afte a few hours so I usually take it off to get some sleep. If it weren't for the compression sleeve, my pinky would swell which interferes with the PT exercises. I use a heating pad to reduce the swelling in order to do the PT.

To Diane and Sandy: I don't think Xiaflex is a cure all, but its action of reabsorbing the dupuytren's tissue seems to be a logical way to manage the growth and live with the disease but I agree that we don't know what happens to other body processes with a foreign substance like that in the body. For my next contracture (I believe there will be another on my other hand) I would opt for NA over Xiaflex if the chord was in the palm/mpj. Having had NA 3 times, I find it relatively painless, quick and barely no recovery. In the NE, I had two done in NJ for about $1500, and one done in MA for about $400 out of pocket expense. If the chord is aggressive, I would beg for a partial or segmented (see J.P. Moermans 1997 thesis on this). If my only option was OS, I'd go home and think long and hard about going through it again. I chronicled my OS experience with photos and they are not pretty. It was very painful for 4 months and it continues to be a major everyday nuisance simply trying to use my hand. The pinky gets terribly cold very quickly in the winter weather - we'll see what happens this summer.

Bob

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