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Do Xiaflex injections really have a low Dupuytren recurrence rate?

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What does “recurrence rate for Dupuytren contracture” mean? 

Dupuytren contracture is famous for the fact that in about half of the cases the problem returns about five years after hand surgery. For some people the reappearance is as soon as one year after an invasive operation to remove the cords, nodules and contracted hand tissue.  Many people are disheartened to learn that surgery and Xiaflex injections are not a final answer to their hand problem because of Dupuytren recurrence.

Consider a brief delay of Xiaflex injections to see if natural remedies might help

The Dupuytren Contracture Institute is not against Xiaflex injections or surgery for Dupuytren’s contracture.  Since 2002 our position has always been to recommend surgical intervention in those cases that have not responded to an aggressively applied round of conservative Alternative Medicine therapy.  If a brief therapeutic trial of natural Alternative Medicine treatment has limited results, we then advise to have an evaluation from two doctors who specialize in Dupuytren’s contracture for possible surgical or Xiaflex intervention.

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However, there are those who approach the management of their Dupuytren contracture in the reverse order:  They first have hand surgery for their Dupuytren’s problem and only after the problem recurs do they consider conservative treatment.

People from around the world report they rushed into having a hand operation, not knowing of the possible side effects and recurrence issues that develop after invading the area of Dupuytren’s disease. It is DCI‘s opinion that it is safe and reasonable to attempt to improve the body’s ability to heal and repair the problem of Dupuytrens contracture by aggressively using several conservative Alternative Medicine treatment measures for a short time.  We strongly suggest that anyone with Dupuytren contracture works with what is known and what is available – even if it is not perfect – before submitting to potentially risky surgery.  If DCI’s conservative concepts do not improve or eliminate the hand lump, Dupuytren’s surgery can always be done later.

How low is the Dupuytren recurrence rate after Xiaflex treatment?

Auxilium Pharmaceutical, manufacturer of Xiaflex collagenase injections, boasts that in a two-year study Xiaflex had a recurrence rate of 19.3 percent, a considerably lower rate of return than those who used surgical procedures to treat their hand problem.

The answer to the question “Is the Xiaflex recurrence rate for Dupuytren low?” is a qualified yes and no.

Yes, Xiaflex or collagenase treatment results in a considerably lower Dupuytren recurrence rate than hand surgery.  However, this does not necessarily mean that the rate of recurrence is actually low; it only means the problem will come back slower than what happens after invasive hand surgery. The reality is that hand surgery has a tremendously high recurrence rate, so a non-surgical therapy option by comparison will look favorable.

Every child learns that pointing to someone who has done something worse than you does not diminish his crime.  When you told your mother that the child next door stole 25 cents from his mother, you were trying to make yourself look pretty good for stealing only 10 cents from her purse.  Your mother was not swayed by the faulty logic of a scared child.  In the final analysis, even though the numbers were different, both children did something wrong.

And along a similar line of thought, 19.3% recurrence is still a high rate for Dupuytren contracture to come back after being subjected to an invasive medical procedure that carries risks, even though there are other treatment methods that have a considerably higher rate of recurrence.

Most surgeons will admit that any type of physical invasion into the palm (like with surgery or injections) seems to accelerate the progression of Dupuytren’s disease.  Patients note that their previously slow progressing hand contracture not only recurred after surgery but worsened at a faster rate.

Perhaps a better question to ask is, “Would you want to undergo an invasive medical procedure like a Xiaflex injection series, knowing that 20 out of 100 people will have to do it again in two years?”  The answer should take into account that more injections might not be as simple and uneventful as receiving the first Xiaflex injection.

Xiaflex has a short history of treatment of Dupuytren contracture

Since Xiaflex was given FDA approval for Dupuytren contracture treatment in early 2010, not enough time has lapsed and not enough patients have used this procedure for the FDA to know sure what will happen to those 19.3% of patients who have recurrence within two years after receiving a second – or third or fourth – injection series.

For example, recent research information released about Xiaflex at the three year follow-up shows that 34.8% of joints with initial clinical success experienced recurrence, considerably higher than the 19.3% recurrence rate reported at the two year mark.  It is reasonable to speculate that the Xiaflex recurrence rate will continue to increase at the four and five year follow up marks, bringing Xiaflex recurrence much closer to the frequency of hand surgery.

There are two valid issues to consider about repeated injections with a new drug like Xiaflex:

  1. When Xiaflex is injected to dissolve the collage cord of Dupuytren’s contracture it carries the risk of physician error and unintended drug consequences, such as injection into a nerve or artery, accidental leakage causing destruction of tendons or muscles, or drug side effects.
  2. No one knows the long term consequences of multiple Xiaflex injections over time into the same area. After all, 70% of people who receive their first Xiaflex injections find that the Dupuytren cord does not break as it should; they must return one month later for another series of injections; if this does not work, they again must return in one month later.  The manufacturer does not recommend that anyone receives more than three series of Xiaflex injections if it did not dissolve the cord by that time.  In this way the manufacturer of Xiaflex is admitting there is a reasonable limit to how often and how much this drug can be used for the same cord.

Return of Dupuytren after hand surgery

There are two common types of Dupuytren hand surgery. The first is palmar fasciectomy (cutting the palm open to remove the deep connective tissue of the palm and collagen cords) with a 35% recurrence rate after two years.  The other is needle aponeurotomy or palmar fasciotomy (inserting a needle into the palm and blindly slashing at the Dupuytren cords wit h the tip of that needle) with an 85% recurrence rate after two years.

By comparison, yes, the Xiaflex return rate of 19.3% recurrence at two years is lower than aggressive surgery. However, this recurrence rate for Xiaflex is said to be low only because the recurrence rates for the other types of surgery are so terribly high by comparison.

At the Dupuytren Contracture Institute we take the position that it is better to avoid the risk the hand problem will return after undergoing any kind of hand surgery by first attempting Alternative Medicine natural Dupuytren treatment.

Xiaflex and Dupuytren Treatment

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Xiaflex treats Dupuytren contracture by dissolving cords

Xiaflex is the brand name of the enzyme collagenase, produced by Auxilium Pharmaceuticals, Inc.,  that originates from clostridium histolyticum, the same bacterium that causes gas gangrene.  Actually, Xiaflex is a combination of two separate enzymes, called Aux-I and Aux-II that work together to break up the peptide bonds of the collagen protein. In early 2010 the FDA approved Xiaflex for treatment of Dupuytren contracture when a palpable cord is present; Xiaflex was not approved for Dupuytren treatment when only nodules or lumps on palms are found.

Dupuytren’s contracture is a slowly progressive condition that affects five times the number of men than women, affecting the deep soft tissue of the palm of the hand, called the palmar fascia.  The problem is characterized by excessive collagen deposition in the palmar fascia that leads to finger contracture caused by a nodule that can develop a rope-like cord. As Dupuytrens disease progresses, the cord can slowly cause the affected finger(s) to go into flexion contracture toward the palm of the hand.  With one or more fingers locked in a flexed contracture and unable to be straightened or extended, the individual with Dupuytren has significant problems with simple daily activities such as dressing, washing, toileting, and handling objects.

Xiaflex and Dupuytren treatment compared with surgery

The decision to use a surgical treatment for Dupuytren’s contracture depends on multiple factors:

1.    Stage and severity of the current condition
2.    History of prior hand surgery
3.    Status of the skin of the palm
4.    Age
5.    General health status
6.    Occupation
7.    Presence of complicating factors, such as the presence of bony deformity from joint disease or the like.

Surgery for Dupuytren’s contracture is typically considered a reasonable option only when the finger contracture causes a distortion of at least 30º of finger flexion.

Dupuytren surgical and drug options include:

1.   Fasciotomy – surgery in which only the offending cords are cut, without removal of any diseased fascia.  Needle aponeurotomy is a less invasive form of fasciotomy; it is a blind procedure in which the surgeon attempts to weaken the cords by tearing, puncturing and otherwise dividing the cords via a needle tip inserted through the skin, instead of a scalpel.

2.   Fasciectomy – surgery in which diseased, contracted and thickened tissue is cut and removed from the palm and fingers through incisions in the palm and affected finger(s).

a.    Partial fasciectomy – in which only mature and clearly deformed tissue is removed; it is often used in moderate to severe cases where 1 or 2 fingers are involved.

b.    Complete or radical fasciectomy – in which all bands of thickened and abnormal tissue that reduces joint movement and hand function are completely removed, sometimes requiring skin grafting if insufficient healthy skin is available due to the amount of tissue removed or when prior Dupuytren surgery has reduced the amount of available healthy tissue.

3.   Amputation of the affected finger(s) – surgery performed when hand pain and deformity is present to such a degree of impairment because past multiple Dupuytren surgeries have created so much scar tissue and removed so much tissue that no further surgery is possible.

4.  Xiaflex for Dupuytren treatment – used when cords, not nodules, are present.  Enables treatment to be done sooner when the MCP (metacarpophalangeal) or the PIP (proximal interphalangeal) joints are at 20º of finger flexion.   Thus, Xiaflex can be used 10º sooner into the finger flexion progression than surgery.

Xiaflex treatment of a Dupuytren cord requires a doctor to make multiple injections of Xiaflex into the palm of the hand into the Dupuytren’s cord at various points. Twenty four hours later the patient returns to the office for the doctor to forcefully break the cords that were enzymatically weakened the day before, by taking the fingers into extension

Xiaflex is injected into only one cord per treatment series, using a small quantity of Xiaflex solution that is divided between three injection sites selected by the treating doctor. If a first Xiaflex injection does not achieve the desired results then the procedure is repeated again one month later. A patient can only receive three series of Xiaflex treatments per Dupuytren cord.

In 70% of Xiaflex treatments the patient must return one month later for a second series of Xiaflex injections into the same finger cord to complete the procedure because of sufficient cord disruption did not occur at the first procedure.

Reasons to avoid Xiaflex as a Dupuytren treatment

Incorrectly performed injections of Xiaflex may cause damage of the local tendons, blood vessels, joints and nerves.   A mistake of injecting the Xiaflex by even 1mm can have terrible consequences in which permanent loss of finger movement or permanent injury to blood vessels and nerves can occur.    That is why the FDA requires that Xiaflex injections should be performed by a doctor who has been specially trained to make these collagenase injections.  However, this training consists of an online video that contains 20 minutes of training.

Each patient undergoing these injections must know that the recurrence rate of Dupuytren contracture after Xiaflex treatment is for 19.3% recurrence after two years.  This is a lower recurrence rate compared to fasciectomy (34% recurrence) and needle aponeurotomy (85%,recurrence), but still recurrence of the problem.  At this time no one knows if this recurrence rate increases with each subsequent series of injections, or if the degree of Dupuytren thickening worsens each time recurrence occurs..  Also, at this time, no one knows if the long term effects of repeated injections of Xiaflex on healthy tendons, ligaments, arteries, veins and blood vessels.

To avoid the possible side effects and adverse reactions of Xiaflex for Dupuytren treatment, it is worthwhile to consider first using more conservative Alternative Medicine methods before more radical methods like surgery or Xiaflex injections .

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