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Treatment for adults with Dupuytren’s
contracture with a palpable cord

DiseaseProfile

Dupuytren’s contracture is a progressive disease of the hand that can affect patients for a lifetime1

There is no available cure, and a contracture can recur following all treatment options1

Characteristics of the condition

  • A collagen-containing cord forms in the palm and finger2
  • The cord thickens, shortens, and may pull the finger toward the palm2,3

Fibroproliferative disease

  • Increased synthesis of types I and III collagen and reduced ability to break down excess collagen results in collagen deposits4-6
  • Disease recurrence is highly variable and may be due to aggressiveness of disease and prior treatment modality1

Inherited and non-inherited risks1,4

  • Caucasian males, northern European descent
  • Diabetes, cigarette smoking, older age, menopause, and alcohol consumption are risk factors associated with the disease

Prevalence and treatment delays

  • Estimated to affect >14 million people in the United States7
  • 23.1 months mean time between symptom onset and seeing a physician8*

*Data based on Web-based survey that included 192 treatment-seeking patients who self-reported Dupuytren’s diagnosis and/or surgical/needle aponeurotomy treatment.8

Assessment andDiagnosis

When there is a palpable cord and a contracture, consider XIAFLEX® first for your appropriate adult patients9

When evaluating a patient for Dupuytren's contracture, consider the following3,9:

  • Contracture of either the middle joint, also known as proximal interphalangeal (PIP), or the base joint, also known as metacarpophalangeal (MP)
  • Presence of a palpable cord
  • Range of motion in fingers
  • Positive “tabletop test” (hand cannot lay flat on a table)

The joint located at the base of each finger
In clinical trials, XIAFLEX® was studied in 20°–100° contractures in the MP joint.9 Learn more»

The joint located in the middle of each finger
In clinical trials, XIAFLEX® was studied in 20°–80° contractures in the PIP joint.9 Learn more»

2 joints in the same hand
In a clinical trial, XIAFLEX® was studied in the concurrent treatment of 2 affected joints in the same hand, either in the same finger or in different fingers, in the same visit.9 Learn more»

Recurrence is a risk regardless of prior treatment
In a clinical trial, XIAFLEX® was studied in patients who were previously treated with XIAFLEX®, had a contracture recur, and were retreated with XIAFLEX®.9 Learn more»

Mechanismof Disease

Understanding the mechanism of disease

Complex pathophysiology underlies Dupuytren's contracture

  • The disease is thought to have characteristics of an abnormal or exaggerated wound-healing response5
  • Increased synthesis of types I and III collagen and/or inhibition of endogenous human collagenase activity results in increased collagen deposits that can lead to the development of a Dupuytren's cord, which can progress to contracture4-6
  • An increase in contractile forces, transmitted by collagen fibrils attached to myofibroblasts, is thought to result in additional collagen production and deposition5,10,11
  • Over time, the histopathology of the Dupuytren's cord is believed to change from predominantly cellular to relatively acellular12
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Important Safety Information
for XIAFLEX®

  • XIAFLEX® is contraindicated in patients with a history of hypersensitivity to XIAFLEX® or to collagenase used in any other therapeutic application or application method
  • In the controlled and uncontrolled portions of clinical trials in Dupuytren's contracture, flexor tendon ruptures occurred after XIAFLEX® injection. Injection of XIAFLEX® into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, XIAFLEX® should be injected only into the collagen cord with a MP or PIP joint contracture, and care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion should not be more than 2 to 3 mm in depth and avoid injecting more than 4 mm distal to the palmar digital crease
  • Other XIAFLEX®-associated serious local adverse reactions in the controlled and uncontrolled portions of the studies included pulley rupture, ligament injury, complex regional pain syndrome (CRPS), sensory abnormality of the hand, and skin laceration (tear). In a historically controlled post-marketing trial, the incidence of skin laceration (22%) was higher for subjects treated with two concurrent injections of XIAFLEX® compared with subjects treated with up to three single injections in the placebo-controlled premarketing trials (9%). Cases of skin laceration requiring skin graft after finger extension procedures have been reported post-marketing. Signs or symptoms that may reflect serious injury to the injected finger/hand should be promptly evaluated because surgical intervention may be required
  • In the controlled portions of the clinical trials in Dupuytren's contracture, a greater proportion of XIAFLEX®-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX®-associated pruritus increased after more XIAFLEX® injections in patients with Dupuytren's contracture
  • Because XIAFLEX® contains foreign proteins, severe allergic reactions to XIAFLEX® can occur. Anaphylaxis was reported in a post-marketing clinical study in one patient who had previous exposure to XIAFLEX® for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX® injections
  • In the XIAFLEX® trials in Dupuytren's contracture, 70% and 38% of XIAFLEX®-treated patients developed an ecchymosis/contusion or an injection site hemorrhage, respectively. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX® in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX® administration is not known. In addition, it is recommended to avoid use of XIAFLEX® in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
  • In the XIAFLEX® clinical trials for Dupuytren's contracture, the most common adverse reactions reported in ≥25% of patients treated with XIAFLEX® and at an incidence greater than placebo were edema peripheral (eg, swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the injected extremity

Indication

XIAFLEX® is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.

Please see the full Prescribing Information, including Medication Guide.


  1. References:
  2. 1. Feldman G, Rozen N, Rubin G. Dupuytren's contracture: current treatment methods. Isr Med Assoc J. 2017;19(10):648-650.
  3. 2. Badalamente M, Hurst LC. Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren’s contracture. J Hand Surg Am. 2007;32(6):767-774.
  4. 3. Bayat A, McGrouther DA. Management of Dupuytren’s disease—clear advice for an elusive condition. Ann R Coll Surg Engl. 2006;88(1):3-8.
  5. 4. Syed F, Thomas AN, Singh S, Kolluru V, Emeigh Hart SG, Bayat A. In vitro study of novel collagenase (XIAFLEX®) on Dupuytren’s disease fibroblasts displays unique drug related properties. PLoS One. 2012;7(2):e31430.
  6. 5. Hart SE. A primer of collagen biology: synthesis, degradation, subtypes, and role in Dupuytren’s disease. In: Eaton C, Seegenschmiedt MH, Bayat A, Gabbiani G, Werker PMN, Wach W, eds. Dupuytren’s Disease and Related Hyperproliferative Disorders: Principles, Research, and Clinical Perspectives. 1st ed. London, England: Springer; 2012:131-142.
  7. 6. McCarty S, Syed F, Bayat A. Role of the HLA system in the pathogenesis of Dupuytren’s disease. Hand (NY). 2010;5(3):241-250.
  8. 7. Evaluate LTD. Epidemiology (in-depth) Dupuytren’s contracture. November 8, 2017.
  9. 8. DiBenedetti DB, Nguyen D, Zografos L, Ziemiecki R, Zhou X. Prevalence, incidence, and treatments of Dupuytren’s disease in the United States: results from a population-based study. Hand. 2011;6(2):149-158.
  10. 9. XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.
  11. 10. Tomasek JJ, Gabbiani G, Hinz B, Chaponnier C, Brown RA. Myofibroblasts and mechano-regulation of connective tissue remodelling. Nat Rev Mol Cell Biol. 2002;3(5):349-363.
  12. 11. Fitzgerald AM, Kirkpatrick JJ, Foo IT, Naylor IL. A picropolychrome staining technique applied to Dupuytren's tissue. J Hand Surg Br. 1995;20(4):519-524.
  13. 12. Luck JV. Dupuytren’s contracture: a new concept of the pathogenesis correlated with surgical management. J Bone Joint Surg Am. 1959;41A(4):635-664.