Xiapex is a mixture of two collagenases produced by the bacterium C. histolyticum. The two enzymes have complementary substrate specificity, as they cleave interstitial collagen at different sites. The product is injected directly into the cord of tissue responsible for the contracture, causing collagen lysis and cord disruption.1
Two pivotal double-blind studies, CORD I and CORD II, evaluated the efficacy of collagenase C. histolyticum in adults with Dupuytren’s contracture with a palpable cord.
At study entry, patients had a finger flexion contracture of 20° or more and a positive 'table top test', defined as the inability to place the affected finger and palm flat against a table top. Patients were randomised to receive up to 3 injections of collagenase or placebo into the cord at 4-week intervals. If required, a finger extension procedure was performed to facilitate cord disruption.
Approximately four weeks after the last injection, the percentage of patients who had achieved the primary endpoint, a reduction in contracture to 5° or less, was significantly greater in the collagenase arm than in the placebo arm in both CORD I (64% vs 6.8%; p<0.001) and CORD II (44.4% vs 4.8%; p<0.001).1,2,3
- Xiapex Summary of Product Characteristics, February 2011.
- Hurst LC et al. N Engl J Med 2009; 361: 968–79.
- Gilpin D et al. J Hand Surg Am 2010; 35: 2027–38.
Further information: Pfizer