PRIMARY ENDPOINT1
Key Inclusion Criteria1
Treatment
MP=metacarpophalangeal; PIP=proximal interphalangeal.
PATIENT CHARACTERISTICS1
In a combined population from the CORD I and CORD II trials (XIAFLEX® N=95, placebo N=44), XIAFLEX® DEMONSTRATED A REDUCTION IN PIP JOINT CONTRACTURES TO VARIOUS LEVELS9
PIP=proximal interphalangeal.
*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
IMPROVEMENT IN
MEAN RANGE OF MOTION
can occur after the first injection15‡
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*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
‡The mean range of motion increased 30 days after the first injection versus baseline in primary joints, collectively, and in MP and PIP joints, specifically.15
Single Joint Procedure
45° PIP contracture of the 5th finger
Injection and finger extension procedure performed by F. Thomas Kaplan, MD
Actual patient. Images used with permission from physician and patient.
PIP=proximal interphalangeal.
*~24–72 hours later.
In the CORD I and CORD II trials,
(206 out of 249)
of patients were satisfied with XIAFLEX® compared with 30% (38 out of 125) of patients with placebo16*
PIP=proximal interphalangeal.
PRIMARY ENDPOINT1
Key Inclusion Criteria1
Treatment
MP=metacarpophalangeal; PIP=proximal interphalangeal.
PATIENT CHARACTERISTICS1
In a combined population from the CORD I and CORD II trials (XIAFLEX® N=153, placebo N=80), XIAFLEX® DEMONSTRATED A REDUCTION IN MP JOINT CONTRACTURES TO VARIOUS LEVELS9
MP=metacarpophalangeal.
*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
IMPROVEMENT IN
MEAN RANGE OF MOTION
can occur after the first injection15‡
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*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
‡The mean range of motion increased 30 days after the first injection versus baseline in primary joints, collectively, and in MP and PIP joints, specifically.15
Single Joint Procedure
30° MP contracture of the 4th finger
Injection and finger extension procedure performed by Robert Coats II, MD
Actual patient. Images used with permission from physician and patient.
MP=metacarpophalangeal.
*~24–72 hours later.
In the CORD I and CORD II trials,
(206 out of 249)
of patients were satisfied with XIAFLEX® compared with 30% (38 out of 125) of patients with placebo16*
MP=metacarpophalangeal.
In ≥5% of patients treated with XIAFLEX® and at a greater incidence than placebo in pivotal trials through day 90 after up to 3 injections1
Adverse Reaction | XIAFLEX® (N=249) |
Placebo (N=125) |
---|---|---|
All adverse reactions | 98% | 51% |
Edema peripherala | 73% | 5% |
Contusionb | 70% | 3% |
Injection-site hemorrhage | 38% | 3% |
Injection-site reactionc | 35% | 6% |
Pain in extremity | 35% | 4% |
Tenderness | 24% | 0% |
Injection-site swellingd | 24% | 6% |
Prurituse | 15% | 1% |
Lymphadenopathyf | 13% | 0% |
Skin laceration | 9% | 0% |
Lymph node pain | 8% | 0% |
Erythema | 6% | 0% |
Axillary pain | 6% | 0% |
aMost of these events were swelling of the injected hand.
bIncludes the terms: contusion (any body system) and ecchymosis.
cIncludes the terms: injection-site reaction, injection-site erythema, injection-site inflammation, injection-site irritation, injection-site pain, and injection-site warmth.
dIncludes the terms: injection-site swelling and injection-site edema.
eIncludes the terms: pruritus and injection-site pruritus.
fIncludes the terms: lymphadenopathy and axillary mass.
Adverse Reaction | XIAFLEX® (N=715) |
---|---|
Patients with ≥ 1 adverse reaction | 95% |
Edema peripheral | 77% |
Contusion | 59% |
Pain in extremity | 51% |
Laceration | 22% |
Pruritus | 15% |
Injection-site pain | 14% |
Lymphadenopathy | 13% |
Blood blister | 12% |
Injection-site hematoma | 8% |
Axillary pain | 7% |
Injection-site hemorrhage | 6% |
Injection-site swelling | 5% |
Ecchymosis | 5% |
*In this trial, 2 concurrent injections were performed in the same hand.1
PRIMARY OBJECTIVE3
SECONDARY OBJECTIVES3
Key Inclusion Criteria3
Treatment3
Extension Procedure
(~24–72 hours after injection):
MP=metacarpophalangeal; PIP=proximal interphalangeal.
PRIMARY OUTCOME: SAFETY1,3
SECONDARY OUTCOME: CLINICAL SUCCESS3†
85% OF JOINTS RECEIVED LOCAL ANESTHESIA
prior to the finger extension procedure4
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*Only 2 cords were treated concurrently in this trial.3
†In this trial, clinical success was defined as a reduction of contracture to ≤5° at Day 31 after 2 concurrent injections in the same hand.3
‡N values are representative of treated joints.
2 Joint Procedure
30º MP and 50º PIP contracture of the 5th finger
Injection and finger extension procedure performed by Damon C. Adamany, MD
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*~24–72 hours later.
Actual patient. Images used with permission from physician and patient.
OBJECTIVE
Evaluation1
STUDY 4 Time to recurrence in joints that had been successfully treated with XIAFLEX®1,5†
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*Clinical success was defined as a reduction in contracture to 0°–5° 30 days after last XIAFLEX® injection.1,10
†Recurrence was defined as an increase in joint contracture by ≥20° in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening contracture in that joint.1
GIVEN THE PROGRESSIVE NATURE OF DUPUYTREN’S CONTRACTURE, IT MAY BE HELPFUL TO11-13:
OBJECTIVE1
Treatment1,6
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*Clinical success was defined as a reduction in contracture to 0°–5° 30 days after last XIAFLEX® injection.1,10
†Recurrence was defined as an increase in joint contracture by ≥20º in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening contracture in that joint.1
Important Safety Information
for Xiaflex
Indication
XIAFLEX® is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord.
Click for full Prescribing Information and Medication Guide.