PMID- 26216077
OWN - NLM
STAT- MEDLINE
DCOM- 20160707
LR  - 20220408
IS  - 1531-6564 (Electronic)
IS  - 0363-5023 (Linking)
VI  - 40
IP  - 10
DP  - 2015 Oct
TI  - The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum 
      Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, 
      Multicenter Study.
PG  - 1963-71
LID - S0363-5023(15)00813-8 [pii]
LID - 10.1016/j.jhsa.2015.06.099 [doi]
AB  - PURPOSE: To evaluate efficacy and safety of concurrent administration of 2 
      collagenase clostridium histolyticum (CCH) injections to treat 2 joints in the 
      same hand with Dupuytren fixed flexion contractures (FFCs). METHODS: Patients 
      with 2 or more contractures in the same hand caused by palpable cords 
      participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg 
      CCH doses were injected into 1 or 2 cords in the same hand (1 injection per 
      affected joint) during the same visit. Finger extension was performed 
      approximately 24, 48, or 72 or more hours later. Changes in FFC and range of 
      motion, incidence of clinical success (FFC </= 5 degrees ), and adverse events (AEs) were 
      summarized. RESULTS: The study enrolled 715 patients (725 treated joint pairs), 
      and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean 
      total FFC (sum of 2 treated joints) decreased 74%, from 98 degrees  to 27 degrees . Mean total 
      range of motion increased from 90 degrees  to 156 degrees . The incidence of clinical success was 
      65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. 
      Most treatment-related AEs were mild to moderate, resolving without intervention; 
      the most common were swelling of treated extremity, contusion, and pain in 
      extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and 
      safety were similar regardless of time to finger extension. CONCLUSIONS: 
      Collagenase clostridium histolyticum can be used to effectively treat 2 affected 
      joints concurrently without a greater risk of AEs than treatment of a single 
      joint, with the exception of skin laceration. The incidence of clinical success 
      in this study after 1 injection per joint was comparable to phase 3 study results 
      after 3 or more injections per joint. Two concurrent CCH injections may allow 
      more rapid overall treatment of multiple affected joints, and the ability to vary 
      the time between CCH injection and finger extension may allow physicians and 
      patients greater flexibility with scheduling treatment.
CI  - Copyright (c) 2015 American Society for Surgery of the Hand. Published by Elsevier 
      Inc. All rights reserved.
FAU - Gaston, R Glenn
AU  - Gaston RG
AD  - OrthoCarolina, Inc., Charlotte, NC. Electronic address: 
      glenn.gaston@orthocarolina.com.
FAU - Larsen, Soren Erik
AU  - Larsen SE
AD  - Unit for Hand Surgery, Department of Orthopaedics, Odense University Hospital, 
      Odense, Denmark.
FAU - Pess, Gary M
AU  - Pess GM
AD  - Central Jersey Hand Surgery, Eatontown, NJ.
FAU - Coleman, Stephen
AU  - Coleman S
AD  - Brisbane Hand and Upper Limb Clinic, Brisbane, Queensland, Australia.
FAU - Dean, Brian
AU  - Dean B
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
FAU - Cohen, Brian M
AU  - Cohen BM
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
FAU - Kaufman, Gregory J
AU  - Kaufman GJ
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
FAU - Tursi, James P
AU  - Tursi JP
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
FAU - Hurst, Lawrence C
AU  - Hurst LC
AD  - Stony Brook University Medical Center, Stony Brook, NY.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150726
PL  - United States
TA  - J Hand Surg Am
JT  - The Journal of hand surgery
JID - 7609631
RN  - EC 3.4.24.3 (Microbial Collagenase)
SB  - IM
CIN - J Hand Surg Am. 2016 Jun;41(6):e157. PMID: 27265765
MH  - Aged
MH  - Clostridium histolyticum/*enzymology
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Dupuytren Contracture/diagnostic imaging/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Hand Strength/physiology
MH  - Humans
MH  - Injections, Intralesional
MH  - Male
MH  - Microbial Collagenase/*administration & dosage
MH  - Middle Aged
MH  - Prospective Studies
MH  - Radiography
MH  - Range of Motion, Articular/*drug effects
MH  - Recovery of Function
MH  - Retreatment
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Collagenase clostridium histolyticum
OT  - Dupuytren disease
OT  - concurrent injections
OT  - fixed flexion contracture
OT  - range of motion
EDAT- 2015/07/29 06:00
MHDA- 2016/07/09 06:00
CRDT- 2015/07/29 06:00
PHST- 2015/01/30 00:00 [received]
PHST- 2015/06/05 00:00 [revised]
PHST- 2015/06/09 00:00 [accepted]
PHST- 2015/07/29 06:00 [entrez]
PHST- 2015/07/29 06:00 [pubmed]
PHST- 2016/07/09 06:00 [medline]
AID - S0363-5023(15)00813-8 [pii]
AID - 10.1016/j.jhsa.2015.06.099 [doi]
PST - ppublish
SO  - J Hand Surg Am. 2015 Oct;40(10):1963-71. doi: 10.1016/j.jhsa.2015.06.099. Epub 
      2015 Jul 26.