Floor plan - 2013 Annual Meeting - American Association for Hand ...

AAHS Concurrent Scientific Paper Session B
Injectable Collagenase Enzyme (AA4500) in Dupuytren's Contracture: Clinical Success in
Patients with Concomitant Diabetes
Institution where the work was prepared: SUNY at Stony Brook, Stony Brook, NY, USA
Marie Badalamente, PhD; Lawrence C. Hurst; SUNY-Stony Brook
INTRODUCTION:
In phase II and III controlled clinical trials, injectable collagenase enzyme (AA4500, Auxilium Pharmaceuticals, Inc.) has been shown to
be an effective nonsurgical treatment for improving finger joint function in patients with Dupuytren's contracture (DC), a progressive
fixed flexion deformity associated with abnormal collagen synthesis. The prevalence of DC is 3 to 4 times greater in diabetic patients
than in nondiabetic patients. In the US, diabetes occurs in almost 10% of people aged 20 years and older, and increases to nearly 21%
after age 60.
METHODS:
A post hoc analysis was performed to compare efficacy and safety of AA4500 in the treatment of DC in diabetic (n=17) and nondiabetic
(n=108) patients in one phase II trial and one phase III clinical trial. Clinical success was defined as correction of metacarpophalangeal
(MP) and/or proximal interphalangeal (PIP) joint contractures to 0 to 5 degrees extension (normal=0 degrees) following treatment with
1 to 3 injections of 0.58 mg AA4500 into the cords affecting MP or PIP joints. Tolerability was evaluated from adverse events (AEs) recorded
for diabetic and nondiabetic patients with DC receiving AA4500 or placebo injections.
RESULTS:
Overall clinical success rates were 58.3% for 24 joints treated in 17 diabetic patients with DC, and 74.7% for 146 joints treated in 108
nondiabetic patients with DC. Success rates were lower for diabetic patients than for nondiabetic patients (64.3% vs 87.3% for the MP
joint; 50% vs 62.7% for the PIP joint). In diabetic patients, success rates were 33.3% (n=3), 61.5% (n=13), and 62.5% (n=8) for middle, ring
and little finger joints, respectively, and 87.5% (n=16), 75% (n=44), and 70.4% (n=81) for middle, ring and little finger joints, respectively,
in nondiabetic patients. Treatment-related AEs were similar for diabetic and nondiabetic patients who received at least 1 injection of
AA4500. The 5 most common AEs were hand edema (76.5% vs 84.3%), ecchymosis (58.8% vs 62%), tenderness (58.8% vs 50%), injection
site pain (35.3% vs 31.5%), and elbow and/or axillary lymphadenopathy (23.5% vs 25.9%) for diabetic and nondiabetic patients,
respectively.
DISCUSSION:
Marked improvements in correction of joint contractures and joint function were achieved for diabetic and nondiabetic patients with
DC following treatment with AA4500. Although the clinical success rate was lower for diabetic than nondiabetic patients, this nonsurgical
approach provides an important alternative in a population more prone to surgical complications. AA4500 had the same tolerability
profile in both groups in this study.
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