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

CORD I & CORD II
XIAFLEX® is the first and only FDA-approved minimally invasive option with proven efficacy for a broad range of adults with Dupuytren's contracture with a palpable cord. Learn more about our CORD I and CORD II pivotal trials.

CORD I and CORD II: 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PIVOTAL TRIALS1*

Inclusion criteria

At the study entry, patients must have had:

  • Flexion contracture with a palpable cord in at least 1 finger (other than the thumb)
  • Positive "table top test"
  • MP joint contractures 20°–100°; PIP joint contractures 20°–80°1

Exclusion criteria

At study entry, patients could not have received:

  • A surgical treatment on the selected primary joint within 90 days before the first injection
  • Anticoagulant medication within 7 days before the first injection (except for up to 150 mg of aspirin per day)1

Treatment

  • The cord affecting the selected primary joint received up to 3 injections of 0.58 mg of XIAFLEX® or placebo on Days 0, 30, and 601
  • About 24 hours after each injection of study medication, if needed, the investigator manipulated (extended) the treated finger in an attempt to facilitate rupture of the cord (finger extension procedure)1
  • Patients did not receive local anesthesia for the manipulation procedure during the trials2
  • Following manipulation, patients were fitted with a splint, instructed to wear the splint at bedtime for up to 4 months, and instructed to perform a series of finger flexion and extension exercises each day1

XIAFLEX® Injection Procedure

Needle placement and injection
Illustration of HCP injecting XIAFLEX into patient's contracture

Next-Day Follow-Up Visit

Finger extension procedure
Illustration of HCP extending patients finger

30-Day
Follow-Up Visit

Assessment to evaluate reduction in contracture of the selected primary joint (MP or PIP) to within 0°–5° of normal1

Primary endpoint

  • Percentage of patients achieving a reduction in contracture of the selected primary joint—MP or PIP—to within 0°–5° of normal, 30 days after the last injection of that joint on Days 30, 60, or 90 (after up to 3 injections)1

*Collagenase Option for Reduction of Dupuytren’s (CORD) I and II.

EFFICACY EVALUATED IN CLINICAL TRIALS FOR A BROAD RANGE OF MP CONTRACTURES1*†

A greater percentage of patients experienced near-complete correction with XIAFLEX® than placebo3

Chart of data on MP joint response rates by severity of contracture
Demonstrated Results in Less Severe Contractures

*Patients may have received up to 3 injections of study medication into the cords associated with contracture of the primary joints on Days 0, 30, and 60. Assessments were made 30 days after the last injection (on Days 30, 60, or 90).1

XIAFLEX®-treated patients received a mean of 1.7 injections in the 90-day controlled period in each clinical trial.1

Range in MP contracture studied in clinical trials

20°–100°

EFFICACY EVALUATED IN CLINICAL TRIALS FOR A BROAD RANGE OF PIP CONTRACTURES1*†

A greater percentage of patients experienced near-complete correction with XIAFLEX® than placebo3

Chart of data on PIP joint response rates by severity of contracture
Demonstrated Results in Less Severe Contractures

*Patients may have received up to 3 injections of study medication into the cords associated with contracture of the primary joints on Days 0, 30, and 60. Assessments were made 30 days after the last injection (on Days 30, 60, or 90).1

XIAFLEX®-treated patients received a mean of 1.7 injections in the 90-day controlled period in each clinical trial.1

Range in PIP contracture studied in clinical trials

20°–80°

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.1

IMPROVED RANGE OF MOTION IN MANY PATIENTS TREATED WITH XIAFLEX®1

MP joints

Mean increase in range of motion from baseline seen in MP joints 30 days after up to 3 injections with XIAFLEX®1*†


CORD I Trial

41°

Mean improvement in range of motion in primary MP joints treated with XIAFLEX® (N=129) vs 4° with placebo.1 Mean range of motion in joints treated with placebo was 46° before and 50° after (N=68).1

XIAFLEX cord 1 trial hand displaying range of motion of joints before and after XIAFLEX®

Range of Motion Before XIAFLEX®

Range of Motion After XIAFLEX®

CORD II Trial

40°

Mean improvement in range of motion in primary MP joints treated with XIAFLEX® (N=20) vs 9° with placebo.1 Mean range of motion in joints treated with placebo was 41° before and 50° after (N=11).1

Cord 2 trial hand displaying range of motion in MP joints before and after XIAFLEX(R)

Range of Motion Before XIAFLEX®

Range of Motion After XIAFLEX®

On average, XIAFLEX® nearly doubled patients’ range of motion in MP joints1

PIP joints

Mean increase in range of motion from baseline seen in PIP joints 30 days after up to 3 injections with XIAFLEX®1*†


CORD I Trial

28°

Mean improvement in range of motion in primary PIP joints treated with XIAFLEX® (N=67) vs 5° with placebo.1 Mean range of motion in joints treated with placebo was 44° before and 49° after (N=34).1

Cord 1 trial hand displaying range of motion in PIP joints before and after XIAFLEX(R)

Range of Motion Before XIAFLEX®

Range of Motion After XIAFLEX®

CORD II Trial

32°

Mean improvement in range of motion in primary PIP joints treated with XIAFLEX® (N=25) vs 7° with placebo.1 Mean range of motion in joints treated with placebo was 47° before and 54° after (N=10).1

Cord 2 trial hand displaying range of motion in PIP joints before and after XIAFLEX(R)

Range of Motion After XIAFLEX®

Range of Motion After XIAFLEX®

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

*Patients may have received up to 3 injections of study medication into the cords associated with contracture of the primary joints on Days 0, 30, and 60. Assessments were made 30 days after the last injection (on Days 30, 60, or 90).1

XIAFLEX®-treated patients received a mean of 1.7 injections in the 90-day controlled period in each clinical trial.1

ADVERSE REACTIONS IN PIVOTAL TRIALS

In CORD I and CORD II trials, most adverse reactions were localized to the treatment hand and resolved without medical intervention within 4 weeks1

Adverse Reactions in ≥5% of Patients Treated With XIAFLEX® and at a Greater Incidence Than Placebo in Pivotal Trials After up to 3 Injections1

Adverse reactions table for CORD 1 and CORD II trials

In clinical trials of 1082 patients treated with 2630 injections, 3 (0.3%) patients had a tendon rupture within 7 days of the injection1

  1. Most of these events were swelling of the injected hand.
  2. Includes the terms: contusion (any body system) and ecchymosis.
  3. Includes the terms: injection site reaction, injection site erythema, injection site inflammation, injection site irritation, injection site pain, and injection site warmth.
  4. Includes the terms: injection site swelling and injection site edema.
  5. Includes the terms: pruritus and injection site pruritus.
  6. Includes the terms: lymphadenopathy and axillary mass.
For your adult patients with Dupuytren's contracture with a palpable cord, consider 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.