Treatment of Dupuytren’s contracture with collagenase clostridium histolyticum under clinical practice conditions: ReDUCTo study

Abstract

Background: To date, real-life data on non-surgical correction of Dupuytren’s contracture with collagenase clostridium histolyticum injection (CCH, Xiapex) are limited. Methods and results: In an open-label non-interventional study in in Germany (mean age 65.1±9.8 years, 79.3% males), patients were followed up until 1 year after injection. 63 (73.3%) received the injection at the MCP joint, and 23 (26.7%) at the PIP. The mean grade of contracture in the presently treated finger at baseline was for the MCP joint 32.4°±25.1, for the PIP° 29.2±31.5, and for the DIP° 0.5±2.0. At days 30/360 compared to baseline, the degree of contracture of the MCP joint was reduced by 28.2°±24.6/30.8°±25.0, of the PIP by 20.0°±24.7/8.5°±29.6, and of the DIP by 0.01°±1.9/0.7±2.3. Improvement of hand function at day 30/360 was rated by physicians as very good in 69.5/60.9%, as good in 23.2/28.3%, and as poor in 7.3/8.7%, and none in 0.0/2.2%. No serious adverse drug reactions (SADR) occurred. Adverse drug reactions (ADR) were noted within injection in 64 patients (74.4%), mostly contusion/swelling, pain, blood blister or other bleeding at the injection site, or ecchymosis. In an overall assessment, at day 30/360, 73.5%/95.7% of the physicians rated tolerability of CCH in their patients as very good, 22.9%/2.2% as good, and 3.6%/2.2% as moderate. On the EQ-5D Visual Analog Scale the mean score improved from 79.5±17.9 to 83.8±15.8 at day 30, and to 85.4±14.1 at day 360. On the Michigan Hand Questionnaire, the total score was 67.5 points at baseline, at day 30 and 75.2 points at day 360.Conclusions: Overall, treatment with CCH under clinical practice conditions was effective and well tolerated. Quality of life and hand function improved substantially. No unknown safety issues were identified during the study.

Keywords

• Dupuytren’s contracture
• microbial collagenase
• injection
• range of motion
• patient satisfaction
• EQ-5D
• safety
• treatment outcome