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Treatment of Recurrent Dupuytren's Contractures in Joints Effectively Treated With Collagenase Clostridium Histolyticum: Interim Results
Clayton A. Peimer, MD1; Chris Bainbridge, MBChB, FRCS2; Stephan Wilbrand, MD3; Gregory J. Kaufman, MD4; James P. Tursi, MD4; Ted Smith, PhD4; Yan Ling, MD, PhD4
1College of Human Medicine, Michigan State University, Marquette, MI; 2Department of Hand Surgery, The Pulvertaft Hand Unit, Derby, United Kingdom; 3Uppsala University Hospital, Uppsala, Sweden; 4Auxilium Pharmaceuticals, Inc, Chesterbrook, PA

Introduction: Recurrence of Dupuytren's contracture is common following treatment, regardless of initial intervention. Collagenase clostridium histolyticum (CCH) is approved in the US for treatment of adult patients with Dupuytren's contracture with a palpable cord. This study assessed safety and efficacy of CCH in the retreatment of recurrent contractures in joints that were previously effectively treated with CCH.

Methods: This open-label Phase 4 study included patients who were participating in a long-term follow-up study and who had recurrence of contracture (increase ≥20° [compared with the Day 30 value after the last injection in the previous study] and a palpable cord) in a joint that had been effectively treated (reduction in contracture to ≤5°) in the previous study. The cord affecting the recurrent joint was treated with up to 3 CCH injections (28 days apart). Outcomes included changes in contracture and range of motion (ROM), physician assessment of improvement, patient satisfaction with treatment at Day 30 after the last injection, and adverse events (AEs). All patients completed the Day 30 follow-up visit; final results will be available when all patients have completed the 1-year follow-up visit.

Results: The study included 51 patients with 1 treated joint/patient (31 metacarpophalangeal [MP], 20 proximal interphalangeal [PIP]). Of 51 joints, 35 (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Overall, 44/51 joints (86%) reached a positive end point (clinical success, patient satisfied with treatment, or no palpable cord). Specifically, 29/51 joints (57%) achieved contracture ≤5° (clinical success), 8/51 (16%) were not treated to ≤5° as the patient was satisfied with the results and opted not to have further injections, and 7/ 51 (14%) did not receive further injections due to lack of palpable cord. Additional results are summarized in the Table. The AE profile was consistent with what was observed in Phase 3 trials. Most frequently reported AEs include edema peripheral, contusion, pain in extremity, injection site pain, and pruritus, all of which were mild or moderate. No tendon injuries were reported; there was 1 mild ligament injury (an A2 pulley strain which resolved after 6 months without intervention).

Conclusions: The results suggest that recurrent contracture in joints that previously had been treated successfully with CCH can be safely and successfully retreated with CCH.

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