Xiaflex Injections in the Treatment of Dupuytren's Disease
UPDATE JUNE 2019: The manufacturer has stopped selling Xiaflex in Australia. As far as I am aware, this is for business reasons rather than clinical or safety issues.
How does collagenase work?
The contracture of Dupuytren's disease is due to a thick linear deposit of collagen (the "cord"), which slowly tightens and pulls the finger down into the palm. CCH (collagenase clostridium histolyticum, trade name Xiaflex) is an enzyme mixture which can break down this collagen. The cord becomes weakened and then ruptures, allowing the finger to straighten.
How is the injection given?
A simple injection directly into the cord. This is done in the rooms (but not at the time of your first consultation). Local anaesthetic is not necessary. You need to stay for 30 minutes afterwards to check there are no signs of allergic reaction.
You will be reviewed a few days later. If the cord has not ruptured by itself, it will be encouraged by a fairly forceful stretch of the finger. Visits to the hand therapists will be arranged, for an exercise program plus a splint to wear at night. You can return to normal activities whenever the finger is comfortable, usually a few days.
If the cord does not rupture, the entire process can be repeated four weeks later.
What are the results?
Over 50% of patients obtain a near-straight finger at 30 days, with an average of 70-80% improvement in the contracture.
Who can give it?
From the Therapeutic Goods Administration licensing conditions:
"XIAFLEX is only to be administered by qualified doctors who are experienced in the diagnosis of Dupuytren's disease and are experienced in injection procedures of the hand. All qualified doctors must have either experience in the surgical management of Dupuytren's disease or been an investigator in the clinical trial program. All qualified doctors must have undergone a prescriber education and training program by Actelion Pharmaceuticals Australia Pty Ltd including training in the appropriate administration of XIAFLEX".
Dr Rider is fully licensed (accreditation number: 38631383186148).
Is it safe?
It was approved by the FDA in the US in 2010, in the EU in 2011, and by Australia's TGA in 2013.
No severe side effects were reported during the extensive trials. However, a life-threatening allergic reaction (anaphylaxis) is theoretically possible, and indeed there are anecdotal reports of these occurring outside of the trial experience.
The most severe problem seen in the trials was tendon rupture, leading to loss of movement in the finger. Tendon is made of similar tissue to the Dupuytren's cord. If collagenase is accidentally injected into the tendon, it may rupture. Further surgery will be necessary, with prolonged rehab and an uncertain outcome. This complication should be very rare.
The risk of very long-term effects, particularly auto-immune syndromes, is not known.
What are other possible side-effects?
Bruising and swelling are common following the injection, and can be severe. Pain, itch, rash and swollen glands are not uncommon. The skin can tear during the second stage stretch. Nerve injury and Chronic Regional Pain Syndrome have been reported.
Which Dupuytren's patients are most suited?
- A mild to moderate contracture of a single finger, with a clearly defined single cord, and minimal skin involvement.
It is less/not suitable for:
- widespread diffuse disease without a discrete cord
- recurrent disease
- longstanding and severe contracture of the PIPJ (first joint in the finger)
- people taking blood-thinners (apart from aspirin)
- the highly anxious
How does it compare to surgery?
Collagenase is better in respect of:
- much more rapid recovery and return to normal activities
- preferred by patients
- fewer hand therapy visits
- less/no wounds or scars
- no risks of surgery and anaesthesia
They are similar in terms of:
- long-term rate of recurrence of the Dupuytren's tissue
Surgery is better:
- for the fairly large proportion of patients who have unsuitable Dupuytren's disease patterns, or take anti-coagulants
Collagenase is worse:
- If it doesn't work (the cord fails to rupture)
- More expensive (especially if repeat injections are required)
What is the cost?
Xiaflex is not (yet) listed in the PBS and does not carry an item number. This means the entire cost of the treatment is "out-of-pocket", without any reimbursement by Medicare or your Health Fund. When comparing, bear in mind there are also significant out-of-pocket costs for surgery.
Where can I get more information?
Download the Xiaflex Patient Guide (PDF, 1.9MB)