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)

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

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.

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

---

Edited 04/06/10 22:20

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