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

TRIAL OF 2 JOINTS TREATED CONCURRENTLY
Read on to see the results of this post-approval trial.

A HISTORICALLY CONTROLLED, OPEN-LABEL MULTICENTER TRIAL ASSESSING THE SAFETY OF XIAFLEX®*

This post-approval trial supports concurrent use in 2 cords and provides a flexible finger extension window

  • The trial investigated1:
    • Treatment of 2 joints with palpable cords on the same hand in 1 office visit
    • Expanding the finger extension procedure ~24–72 hours after injection
  • Trial characteristics:
    • Patient demographics were similar to those of the CORD I and II trials1
  • 2 palpable cords affecting 2 joints, or 1 palpable cord affecting 2 joints in the same finger, were injected at 2 locations during a single treatment visit7†:
    • 48% were 1 MP joint and 1 PIP joint on the same finger (N=350)
    • 34% were 2 MP joints on the same hand, different fingers (N=244)
    • 10% were 2 PIP joints on the same hand, different fingers (N=72)
    • 8% were 1 MP joint and 1 PIP joint on the same hand, different fingers (N=58)
  • The full clinical dose of 0.58 mg was injected into each palpable cord1,7
  • The times of finger extension procedure were performed at the following rates: 37% at 24 hours, 41% at 48 hours, and 22% at ≥72 hours7
  • Overall, 85% of joints (1226/1446) received local anesthesia prior to the finger extension procedure8

* Historically controlled refers to the double-blind, randomized, controlled, single-joint CORD I and CORD II trials.1,8

Only 2 cords were treated concurrently in this trial.7

For your adult patients with Dupuytren's contracture with a palpable cord, consider XIAFLEX®

CLINICAL OUTCOMES IN THE TRIAL OF 2 JOINTS TREATED CONCURRENTLY

Primary outcome measure8

  • Incidence of tendon rupture/ligament injury and anaphylaxis7
    • 1 patient (0.1%; N=715) experienced tendon rupture of the treated finger within 3 days of injection1
    • 1 patient (0.1%) experienced anaphylaxis7

Secondary outcome measure8

  • Time of finger extension after injection had no impact on the rate of clinical success for either MP or PIP joints7
  • Clinical success was achieved in 65% of MP joints and 29% of PIP joints7*

Clinical Success by Joint Type7*

Chart of data on the clinical success by joint type

Proportion of joints corrected ≤5˚ at Day 31 after 2 concurrent injections in the same hand

* In this trial, clinical success was defined as a reduction of contracture of ≤5˚ at Day 31 after 2 concurrent injections in the same hand.7

ADVERSE REACTIONS

Concurrent Use in 2 Joints Trial

Adverse Reactions Occurring in ≥5% of Patients Who Received 2 Concurrent Injections of XIAFLEX®1

Chart of data on the adverse reactions occurring with concurrent use in 2 joints trial

In the post-approval trial of 715 patients treated with 1450 injections, 1 (0.1%) patient had a tendon rupture within 3 days of the injection1

For your adult patients with Dupuytren’s contracture, consider the only FDA-approved minimally invasive treatment option—XIAFLEX®
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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.

References:

1.  XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.
2.  Raven RB 3rd, Kushner H, Nguyen D, Naam N, Curtin C. Analysis of efficacy and safety of treatment with collagenase clostridium histolyticum among subgroups of patients with Dupuytren contracture. Ann Plast Surg. 2014;73(3):286-290.
3.  Hurst LC, Badalamente MA, Hentz VR, et al; for CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. N Engl J Med. 2009;361(10):968-979.
4.  Data on file. DOF-XDC-07. Endo Pharmaceuticals Inc; July 29, 2015.
5.  Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren’s disease. J Hand Surg Am. 2010;35(12):2027-2038.
6.  Data on file. DOF-XDC-08. Endo Pharmaceuticals Inc; July 24, 2015.
7.  Gaston RG, Larsen SE, Pess GM, et al. The efficacy and safety of concurrent collagenase clostridium histolyticum injections for 2 Dupuytren contractures in the same hand: a prospective, multicenter study. J Hand Surg Am. 2015;40(10):1963-1971.
8.  Data on file. DOF-XDC-03. Endo Pharmaceuticals Inc; July 21, 2015.
9.  Hay DC, Louie DL, Earp BE, Kaplan FT, Akelman E, Blazar PE. Surgical findings in the treatment of Dupuytren’s disease after initial treatment with clostridial collagenase (Xiaflex). J Hand Surg Eur Vol. 2014;39(5):463-465.
10.  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.
11.  Townley WA, Baker R, Sheppard N, Grobbelaar AO. Dupuytren’s contracture unfolded. BMJ. 2006;332(7538):397-400.
12.  Data on file. DOF-XDC-09. Endo Pharmaceuticals Inc; June 10, 2015.