Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population.
To assess the efficacy, safety and pharmacokinetics of 0.58 mg collagenase Clostridium histolyticum injections for the treatment of Dupuytren's contracture in Japanese patients, we conducted a phase III, multicentre, uncontrolled, open-label clinical study in patients with Dupuytren's contracture. Of the 77 patients, 66 achieved clinical success in the primary treated joint (86%; 95% confidence interval: 76% to 93%), confirming the efficacy of collagenase Clostridium histolyticum injections. More improvement was seen in the metacarpophalangeal joints than in the proximal interphalangeal joints (94% versus 73%). The main adverse reaction was a local reaction in the injected hand. No tendon rupture or anaphylactic reactions were seen. The concentrations of collagenase Clostridium histolyticum were below the lower limit of quantification in plasma samples at all time points. As seen in global studies in Caucasian patients, a corrective effect on Dupuytren's contracture and good tolerance were observed in most non-Caucasian (Asian) Japanese patients.


METHODS
Level 3.
1 Department of Hand Surgery, Graduate School of Nagoya University, Nagoya, Japan.
H
H
Hirata
2 Department of Plastic and Reconstructive Surgery, Nagasaki University, Nagasaki, Japan.
K
K
Tanaka
3 Department of Orthopaedic Surgery, University of Occupational and Environmental Health, Kitakyushu, Japan.
A
A
Sakai
4 Department of Rehabilitation Medicine, Kyoto University Hospital, Kyoto, Japan.|a Current address: Department of Orthopaedic Surgery, Kindai University, Osaka, Japan.
R
R
Kakinoki
5 Department of Orthopedic Surgery, Toho University Ohashi Medical Center, Tokyo, Japan.
H
H
Ikegami
6 Development Planning, Clinical Development Center, Asahi Kasei Pharma Corporation, Tokyo, Japan.
N
N
Tateishi
Collagenase Clostridium histolyticum; Dupuytren’s contracture; fixed flexion; non-surgical; open label