OBJECTIVE: The efficacy and safety of collagenase clostridium histolyticum (CCH) in patients with Dupuytren's contracture (DC) was demonstrated in a program including two pivotal phase 3 clinical trials (CORD I and II) which included patients with a broad range of disease severity. This analysis assessed the efficacy and safety of CCH in the subpopulation of DC patients with up to two joints affected and moderate disease according to British Society of Surgery of the Hand classification. This was in support of a resubmission to the Scottish Medicines Consortium. RESEARCH DESIGN AND METHODS: A post-hoc analysis that included data from patients with up to two joints affected and moderate disease treated withCCH during the randomized and open-label phases of CORD I and II. RESULTS: Of 362 patients who received CCH during the two trials, 58 had one or two joints affected and moderate disease. Sixty-seven joints were treated; 49 patients received treatment for one joint, and 9 patients received treatment for two joints. Each patient received an average of 1.62 injections of CCH per joint. Of 65 evaluable joints, 82% met the primary endpoint of clinical success (reduction in contracture to ≤5° of full extension 30 days after the last injection). This was similar if only primary joints were considered (81% achieved clinical success). Recurrence at 12 months (increase in joint contracture to ≥20° in the presence of a palpable cord in joints that had attained clinical success) was observed in 3.8% of joints. Reported adverse events were mild to moderate in intensity; none resulted in discontinuation. CONCLUSIONS: CORD I and II show that CCH is well tolerated and effective in the treatment of DC in a broad population. The present analysis suggests that CCH has particular value in patients with moderate severity disease and up to two joints affected. STUDY LIMITATIONS: This analysis used data from both the randomized and open-label phases of CORD I and II; therefore, it is not possible to present comparative data for this subpopulation. As this was a post-hoc analysis in a relatively small patient subpopulation, statistical comparisons with the full population were not considered appropriate. Furthermore, the small sample size means that additional subgroup analyses, for example of patients by previous treatment or number of injections administered, are not appropriate. Nevertheless, the data presented demonstrate that CCH is both well tolerated and effective in this population when managed by appropriately trained individuals.
RCT Entities:
OBJECTIVE: The efficacy and safety of collagenase clostridium histolyticum (CCH) in patients with Dupuytren's contracture (DC) was demonstrated in a program including two pivotal phase 3 clinical trials (CORD I and II) which included patients with a broad range of disease severity. This analysis assessed the efficacy and safety of CCH in the subpopulation of DC patients with up to two joints affected and moderate disease according to British Society of Surgery of the Hand classification. This was in support of a resubmission to the Scottish Medicines Consortium. RESEARCH DESIGN AND METHODS: A post-hoc analysis that included data from patients with up to two joints affected and moderate disease treated with CCH during the randomized and open-label phases of CORD I and II. RESULTS: Of 362 patients who received CCH during the two trials, 58 had one or two joints affected and moderate disease. Sixty-seven joints were treated; 49 patients received treatment for one joint, and 9 patients received treatment for two joints. Each patient received an average of 1.62 injections of CCH per joint. Of 65 evaluable joints, 82% met the primary endpoint of clinical success (reduction in contracture to ≤5° of full extension 30 days after the last injection). This was similar if only primary joints were considered (81% achieved clinical success). Recurrence at 12 months (increase in joint contracture to ≥20° in the presence of a palpable cord in joints that had attained clinical success) was observed in 3.8% of joints. Reported adverse events were mild to moderate in intensity; none resulted in discontinuation. CONCLUSIONS: CORD I and II show that CCH is well tolerated and effective in the treatment of DC in a broad population. The present analysis suggests that CCH has particular value in patients with moderate severity disease and up to two joints affected. STUDY LIMITATIONS: This analysis used data from both the randomized and open-label phases of CORD I and II; therefore, it is not possible to present comparative data for this subpopulation. As this was a post-hoc analysis in a relatively small patient subpopulation, statistical comparisons with the full population were not considered appropriate. Furthermore, the small sample size means that additional subgroup analyses, for example of patients by previous treatment or number of injections administered, are not appropriate. Nevertheless, the data presented demonstrate that CCH is both well tolerated and effective in this population when managed by appropriately trained individuals.