Efficacy and safety of collagenase clostridium histolyticum in the treatment of proximal interphalangeal joints in dupuytren XXXX : combined analysis of 4 phase 3 clinical trials.

@entity1 @entity548 @entity4 @entity6520 @entity397 @entity2074 @entity1159 @entity158 @entity925
PURPOSE: To examine the results of proximal interphalangeal (PIP) joint contractures from 4 phase 3 clinical trials of collagenase clostridium histolyticum (CCH) injection for Dupuytren @entity1159 . METHODS: @entity1 enrolled in Collagenase Option for Reduction of Dupuytren I/II and JOINT I/II with one or more @entity1159 (20   to 80  ) received CCH 0.58 mg/0.20 mL or placebo (Collagenase Option for Reduction of Dupuytren I/II only) injected directly into a palpable cord. The percentage of @entity6520 achieving clinical success (0   to 5   of full extension), clinical improvement (50% or more reduction in baseline @entity1159 ), and range of motion improvement at 30 days after the first and last CCH injections was assessed. The @entity1159 were classified into low (40   or less) and high (more than 40  ) baseline severity. Adverse events were recorded. RESULTS: A total of 506 adults (mean age, 63    10 y; 80% male) received 1,165 CCH injections in 644 PIP joint cords (mean, 1.6 injections/cord). Most @entity1 (60%) received 1 injection, with 24%, 16%, and 1% receiving 2, 3, and 4 injections, respectively. Clinical success and clinical improvement occurred in 27% and 49% of @entity6520 after one injection and in 34% and 58% after the last injection. @entity1 with lower baseline severity showed greater improvement and response was comparable between fingers, as were improvements in range of motion. Adverse events occurring in more than 10% of @entity1 were @entity4 (58%), contusion (38%), injection site @entity548 (23%), @entity158 (21%), injection site swelling (16%), and @entity925 (13%). This incidence was consistent with data reported in phase 3 trials. Two @entity397 occurred. No further @entity397 occurred after a modified injection technique was adopted. CONCLUSIONS: Collagenase clostridium histolyticum was effective and well tolerated in the short term in @entity1 with @entity2074 . TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.
