Treatment of Recurrent Dupuytren Contracture in Joints Previously Effectively Treated With Collagenase Clostridium histolyticum.
OBJECTIVE
Collagenase Clostridium histolyticum (CCH) is approved for the treatment of adults with Dupuytren contracture with a palpable cord. This open-label, phase 4 study evaluated the safety and efficacy of CCH for the retreatment of recurrent contractures in joints that were previously effectively treated with CCH.


METHODS
Patients participating in a long-term follow-up study who had contracture recurrence (increased ≥ 20° with a palpable cord) after successful treatment in the previous study were eligible. Recurrent joint contractures were treated with up to 3 CCH injections (∼ 1 month apart). Patients were followed for 1 year to evaluate safety. Assessments included change in joint contracture, range of motion, and the percentage of joints that achieved contracture of 5° or less at day 30 after the last injection.


RESULTS
The efficacy analysis included 51 patients with 1 treated joint per patient (31 metacarpophalangeal, 20 proximal interphalangeal). A total of 35 joints (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Fifty-seven percent of joints achieved contracture of 5° or less (29 of 51). Overall, 86% (43 of 50) patients had a 20° or greater increase in range of motion. The adverse event profile was consistent with previous studies. One ligament injury was reported.


CONCLUSIONS
At a short-term follow-up of 1 year, recurrent contracture in joints previously successfully treated with CCH may be effectively retreated with up to 3 injections of CCH.


METHODS
Therapeutic IV.
Rockford Orthopedic Associates, Rockford, IL. Electronic address: BrianB@RockfordOrtho.com.
Brian J
BJ
Bear
College of Human Medicine, Michigan State University, East Lansing; and the UP Health System-Marquette, Hand Surgery Office, Marquette, MI.
Clayton A
CA
Peimer
Indiana Hand to Shoulder Center, Indianapolis, IN.
F Thomas D
FTD
Kaplan
Endo Pharmaceuticals Inc., Malvern, PA.
Gregory J
GJ
Kaufman
Endo Pharmaceuticals Inc., Malvern, PA.
James P
JP
Tursi
Endo Pharmaceuticals Inc., Malvern, PA.
Ted
T
Smith
D000368:Aged; D004387:Dupuytren Contracture / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D003012:Microbial Collagenase / Q000627:therapeutic use*; D008875:Middle Aged; D016059:Range of Motion, Articular; D012008:Recurrence; D019233:Retreatment; D016896:Treatment Outcome
D003012:Microbial Collagenase
Dupuytren contracture; collagenase Clostridium histolyticum; recurrence