Abstract
Introduction
Injectable collagenase clostridium histolyticum (CCH) is a minimally invasive non-surgical therapy with efficacy in correcting Dupuytren's contracture (DC). In the concurrently run JOINT I and JOINT II studies, designed to follow clinical practice, we evaluated the efficacy of ?5 CCH injections in patients with DC.
Methods
JOINT I and II were multicenter, 9-month, open-label studies in which DC patients with primary flexion deformities ?20° received ?3 CCH (0.58 mg) injections/joint (?5 injections/patient) at 30-day intervals into joints prioritized by extent of contracture. After the first injection, patients could opt to receive up to 2 additional injections in same cord or other cords regardless of outcome for the first joint. The primary endpoint was reduction in contracture to ?5° 30 days after the last injection. Data from JOINT I and II were pooled.
Results
For the primary endpoint, 70% of MP (371/531) and 37% of PIP (128/348) joints showed a reduction in contracture to ?5° with CCH injections; 42% (223/531) of MP and 20% (69/348) of PIP joints reached success within 7 days of the first injection. Overall, 89% of MP (470/531) and 58% (202/348) of PIP joints showed clinical improvement (ie, ?50% reduction in contracture). Mean±SD percentage changes in contracture were 84±25% for MP joints and 55±41% for PIP joints. The 2 most common treatment-related adverse events (AEs) localized to the injection site were edema peripheral and contusion. Two patients had treatment-related serious AEs (deep vein thrombosis; tendonitis), but no tendon ruptures or systemic reactions were noted.
Conclusions
Pooled results from the JOINT studies designed to follow clinical practice, provide support for the efficacy of CCH in correcting DC. Efficacy and safety data from this analysis are comparable to those observed in randomized, placebo-controlled trials.
