Xiapex for Dupuytren's Disease

 

Introduction

There are currently some exciting developments in the treatment of Dupuytren's that are in line with the general shift towards less invasive interventions. In 2012 a new treatment for Dupuytren's was approved for use in the UK after many years of research. Direct injection of the enzyme, clostridium histiolyticum collagenase (Xiapex), into the collagen-rich cords was shown to cause breakdown of the structure of the cord and rupture of diseased digital cords in the year 2000.  However, it has taken many years for the necessary trials to take place to assess the efficacy and safety of the treatment.

Mike Hayton was the first doctor in the UK to inject the enzyme outside a clinical trial and has now performed over 300 injections.

He is currently helping the British Society of Surgery of the Hand in their appeal against NICE regarding Xiapex use in the NHS.

In the past he has been a paid consultant to previous distributors of Xiapex , initially Pfizer and then SOBI. He has not worked as a consultant for the last 12 months to either comany.

Studies

CORD (Collagenase Option for Reduction of Dupuytren's)  I and II were randomised, double blind, placebo controlled studies involving a total of 374 patients with Dupuytren's who had contracture with a cord and a positive Hueston's tabletop test. Success was defined as the proportion of patients with no more than 5 degrees of flexion when the finger is fully extended.  64% of patients met this outcome when treated with collagenase compared with 5.7% who received placebo (non active treatment).

How it is given ?

Initially a thorough consultation with a surgeon trained in the use of Xiapex is required. Whilst Xiapex is very exciting it is not suitable for all patients with Dupuytren's disease. Other treatment options should be discussed before a decision is made regarding the best option for the individual.
After all the risks, complications and likely outcome have been discussed informed consent is obtained for the procedure
Xiapex is injected directly into the cord of the hand and the 24 hours after the injection, under local anaesthetic, the finger can be manipulated by the surgeon to rupture the cord. More than one injection may be required to straighten the finger and the procedure may be repeated at monthly intervals up to a maximum of three injections per cord. The mean number of injections required was 1.5 in the trials. However current clinical practice may not require further injections. The patient may be very happy with a near normal correction after the first injection and a watch and wait policy adopted for the need of further injections.

For more information from SOBI, the european distributor please click on this link

Risks of Xiapex

The most common side effects seen with Xiapex were local injection site reactions such as swelling, bruising, bleeding, pain and small skin tears. These risks are also present with other Dupuytren treatment options. These resolved within ten days. Three tendon ruptures have been reported in the large series of >2000 injections. These all occurred in the little finger. The protocol has changed since the tendon ruptures and safe zones of injection have now been introduced and as such no further tendon injury has been reported. There were no systemic immune reactions and no neurovascular injuries. Other possible complications associated with Xiapex include an allergic reaction, cross reactivity with matrix metalloproteases and arm pit discomfort.
 

Xiapex available on the NHS

We are delighted to announce that Xiapex is available at Wrightington Hospital ( WN6 9EP 2 mins jxn 27 M6). However not all external  PCT's / commisioners have approved its funding as yet.

The use of Xiapex on the NHS is under review and The Final Appraisal Determination (FAD) from NICE states that Xiapex (Collagenase clostridium histolyticum) should only be used in the context of research for treating Dupuytren’s contracture. This controversial decision is being appealed by patient groups, surgeons and the drug company. The appeal process will be completed in 2016. Mike Hayton is representing the British Society for Surgery of the Hand in it's appeal.

Results

Results suggest this treatment is a very attractive viable alternative to surgery but it may not be suitable for all patients. I have now treated over 300 patients with Xiapex and all have been happy with the results to date. I have seen similar improved finger extension (straightening) and patient evaluations scores (PEM) that have been recorded both resulting in a significant improvement in hand function.

However, long-term results are eagerly anticipated to assess the rates of recurrence and trials comparing it to other treatments will follow in due course. Recent data suggests recurrence rates may be 50% of disease recurring at 5 years.

Clip from the Channel 4's TV show Embarrassing Bodies Featuring Mike Hayton

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Hear Mike Hayton and Dr Mark Porter discuss Collagenase injections on BBC Radio 4 Inside Health

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