What is Xiaflex and what are the risks if I take it?

Xiaflex: new collagenase injection has potential to cause injury

Xiaflex is the brand name of collagenase clostridium, a combination of two separate enzymes manufactured by Auxilium Pharmaceuticals known as Aux-I and Aux-II to treat Dupuytren’s contracture. When used as a Dupuytren’s contracture treatment it dissolves the DC cord – any other tissue it contacts by mistake.

Since 2002 this website has suggested the use of conservative Alternative Medicine therapy to avoid the possible side effects and adverse reactions of Dupuytren surgery or drugs.  Learn what you can do to help your hand problem without use of surgery or drugs at Dupuytren Contracture Treatment with Alternative Medicine.

Dupuytren contracture background

In early February 2010 the FDA approved Dupuytren’s Xiaflex treatment for use when a palpable cord is present.  It is not appropriate to administer a collagenase injection if only Dupuytren nodules or palm lumps are present, or for finger joint contractures.   

Collagen is the protein material that is said to be the glue that holds us together.  Collagen is the primary component of the connective tissue of mammals, making up from 25-35% of the total body protein.  It is most abundant in fibrous tissues (tendons, ligaments, cartilage, skin, bone, intervertebral disks and blood vessels) but also the internal structure of all organs (heart, liver, lungs, kidneys, etc.).

Xiaflex side effects

A list of relatively minor and usually temporary Xiaflex side effects includes:

1. Bleeding or bruising at the injection site
2. Pain or tenderness of the injection site or the hand
3. Swelling of the injection site or the hand
4. Swelling and pain in the lymph nodes (glands) of the elbow or underarm
5. Itching at the injection site and lower arm
6. Breaks in the skin
7. Redness or warmth of the skin

However, the potential for serious Xiaflex side effects is two-fold:
1. Accidental injury to nerves, tendons, ligaments and cartilage if the injections are not given properly
2. Recurrence of Dupuytren contracture after receiving a Xiaflex injection series.

While there are positive and beneficial aspects of Xiaflex injections, perhaps because of hopeful enthusiasm, there is not much discussion about the initial evidence of side effects and unintended consequences of Xiaflex use.

Use of Xiaflex for Dupuytren’s contracture

Xiaflex treatment of a Dupuytren cord requires a doctor to make multiple injections of Xiaflex into the Dupuytren’s cord at three points a few millimeters apart. Twenty-four hours later the patient returns for the doctor to forcefully break the cord that was enzymatically weakened the day before, by taking the finger into extension.

Xiaflex is injected into only one cord during a single treatment.  For a cord affecting the MP joint, 0.25 mL of Xiaflex solution is used, and for a cord affecting the PIP joint 0.20 mL of Xiaflex solution is used.  These injection amounts are equally divided between the three injection sites of the cord. If this injection process dose not achieve the desired results then the procedure is repeated again one month later.

In 70% of Xiaflex treatments the patient must return one month later for a second series of Xiaflex injections into the same Dupuytren cord to complete the procedure if insufficient cord disruption did not occur at the first procedure.  A patient can only receive three series of Xiaflex treatments per Dupuytren cord.

Xiaflex side effects greatly dependent on doctor skill and accuracy

Auxilium Pharmaceuticals clearly states that to minimize the risk of serious Xiaflex side effects it is important that it should be done by a doctor trained in their technique for providing collagenase injections.   In the educational video the depth of needle penetration into the cord is recommended to be 3-4mm.  The video does not consider or give instruction for what the doctor should do when the Dupuytren cord being injected is not much more than 3-4 mm thick.  In this situation it is possible for the collagenase clostridium to leak out of the cord, only to contact normal tendon tissue, blood vessels or nerves with damaging consequences.

Given that the slanted point or cut bevel end of a 27-gauge needle is approximately 1.25mm in length, this presents another possible mechanism for Xiaflex leakage.  This means that if the depth of any of the three required  Xiaflex injections is not far enough into the cord, a part of the 1.25mm  bevel cut of the needle tip can be exposed outside the cord, allowing most of the Xiaflex to flush out onto and dissolve normal healthy soft tissue.

While it is true Xiaflex has a lower side-effect rate compared to conventional Dupuytren surgery, it is important to remember this low rate is created during the special circumstances of a clinical drug trial.   The drug companies select only the best doctors and offices to participate in the study, who all know they are being carefully watched. They will naturally produce outstanding results because that is what the drug maker needs.  For this reason it is wise to find the very best doctor to work with you to to ensure that opportunity for side effects are minimized.

Recurrence rate of Dupuytren’s contracture

Dupuytren contracture is well known for the high incidence of rapid recurrence of more cords and nodules and finger contracture after conventional surgery.  Some might think it is acceptable to have a 2nd or 3rd Dupuytren surgery after enjoying a few years of improved hand use until the contracture recurs, but there is a price to pay:

  1. Each surgery reduces the amount of normal healthy tissue in the hand since each intervention reduces normal tissue, making it more difficult each time to perform the next surgery or Xiaflex injection.
  2. Each surgery tends to accelerate the recurrence of the next episode of Dupuytren contracture.
  3. Each surgery tends to make the recurrence of the next episode a little more severe than the prior episode since there is less normal and unaffected tissue remaining.

The two-year recurrence rate of Dupuytren contracture after Xiaflex treatment is 19.3%, compared to fasciectomy (34% recurrence) and needle aponeurotomy (85% recurrence) two year recurrences.  The recurrence rate means that about 19 people out of 100 who receive Xiaflex injections will again have Dupuytren contracture two years later.   This is of course is a lower two rate compared to the 34 out of 100 who will have DC after their fasciectomy surgery and the 85 out of 100 who will have DC after their needle aponeurotomy.

The result is that the more intervention is done to the hand, the more unstable it becomes until eventually no additional hand surgery can be done.

At the Dupuytren’s Contracture Institute our position is to use Alternative Medicine first.   If that fails, then resort to a drug or surgical treatment that will lead to eventual recurrence.

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Dupuytren Surgery and Recurrence of Hand Contracture

Dupuytren surgical treatment temporary relief

After speaking to well over a thousand people about their Dupuytren surgery options, fewer than a handful knew that surgical repair is only a temporary relief of the palm nodules and finger contractures. Only a few knew surgery for Dupuytrens is NOT a one-time and permanent solution.

Recurrence of a second episode of Dupuytren contracture after the first surgery takes approximately five years, sometimes sooner and  sometimes later.  For every example where someone might have a recurrence after as long as ten years, there are many others who have a return in one or two years; five years is a good average.

Here are important ideas to have in mind when you think about having any kind of Dupuytren surgery:

  1. Once you have your first Dupuytren surgery, you will have others because the problem will return.
  2. There is no such thing as cutting the Dupuytrens tissue out and being done with it.  Some surgeon’s refer to cutting out a large and deep mass of tissue as creating a  “firewall of tissue” to keep the problem from returning, but it is only a delay technique.  It will always return; it is just a matter of time.
  3. If you have Dupuytren surgery and your problem recurs in (let’s say) three years, if you have another or second surgery for the first recurrence of the problem your second recurrence will happen in less than three years.   After each Dupuytren surgery the next recurrence happens faster each time.  The return of your hand contracture will be faster after the second surgery, even faster after the third surgery, and even after the fourth surgery, and so on.
  4. After each hand surgery your recovery will be longer and more complicated with greater chance for side effects.  Just like the recurrence problem increasing with each surgery, the amount of numbness, stiffness, pain, scar build up, reduced hand and finger movement and general limitation increases each time you have Dupuytren surgery.
  5. If  your hand has been so scarred, and so much tissue removed by prior surgeries, and pain and limited use of the hand develops, a common solution is to amputate the offending finger(s).

Here is a brief explanation of the different types of Dupuytren surgery and how each rates in terms of recurrence after the first surgery.

  • Regional Fasciectomy: Most common Dupuytren surgery.  The contracted fascia of the palm and involved fingers are surgically removed, requiring general anesthesia or a nerve block.  Requires extended rehabilitation and wound care. Recurrence of Dupuytren contracture – somewhat more frequent than after other types of Dupuytren surgery.
  • Fasciotomy: Less common Dupuytren surgery.  Requires single or multiple incisions (usually in a zig-zag pattern) using widespread dissection over the Dupuytren’s cord, but the diseased tissue is not removed.  Also requires general anesthesia or a nerve block.  Requires extended rehabilitation and wound care. Recurrence is slightly more frequent than a regional fasiectomy.
  • Dermofasciectomy: Less common Dupuytren surgery.  Surgical removal of diseased skin and fascia overlying Dupuytren cords, in which diseased soft tissue of palm is replaced with a skin graft from patient’s forearm.  Requires very long rehabilitation and wound care.  Recurrence is somewhat less frequent than regional fasciectomy.
  • Needle Aponeurotomy (NA): Very popular – and almost faddish – in-office procedure.  While needle aponeurotomy is a minimally invasive Dupuytren surgery in which a needle is inserted and slashed around under the skin of the palm to shred, lacerate and weakened the Dupuytren cords.  After being so weakened, each cord is broken by hyperextending or pulling each finger straight.  Only local anesthesia is needed.  Requires short rehabilitation and minimal wound care.  Recurrence is about average.
  • Collagenase injection: Early in 2010 the US Food and Drug Administration (FDA) approved inject able collagenase extracted from the bacteria Clostridium histolyticum to be used in treatment of Dupuytren contracture.  Collagenase erodes the Dupuytren cords when they are injected with small amounts of this enzyme, breaking the peptide bonds in the cords of collagen.   Recurrence of hand and finger contractures seems to be most frequent with this technique.

None of these surgical procedures has proved to be a way to stop or cure Dupuytren contracture permanently.  It is said that if a patient lives long enough, the finger contractures and palm lumps will return and additional Dupuytren surgery will be needed.

In extreme cases, amputation of fingers may be needed for severe or recurrent disease, or after complications in surgery.

Alternative therapies, such as advocated by Dupuytren Contracture Institute, have received almost no evidence-based research by the large pharmaceutical companies or university medical programs because of their limited profit potential and easy access by laypeople, and so have little support from the medical profession.

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