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Efficacy and Safety of Collagenase Clostridium Histolyticum Treatment for Dupuytren's Contracture: Effect of Delayed Finger Extension
Gary M. Pess, MD1; Robert I. Gelb, MD2; Huey Y. Tien, MD3; Gregory J. Kaufman, MD4; James P. Tursi, MD4; Ted Smith, PhD4
1Central Jersey Hand Surgery, Eatontown, NJ; 2CORE Orthopaedic Medical Center, Encinitas, CA; 3Christine M. Kleinert Institute for Hand and Microsurgery, Louisville, KY; 4Auxilium Pharmaceuticals, Inc, Chesterbrook, PA

Introduction: Treatment of Dupuytren's contracture with collagenase clostridium histolyticum (CCH) involves a single injection of CCH into the cord of the affected joint, followed by a finger extension procedure. Current CCH labeling recommends that the finger extension procedure be performed 24 hours post-injection. In practice, the timing of the procedure may vary due to variability in physicians' clinic hours. The effect of varying time to finger extension was evaluated as part of a study of patients who received two concurrent injections of CCH to concurrently treat two affected joints of the same hand.

Materials and Methods: Patients with ?2 contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label phase 3b study. Patients received two CCH doses (each 0.58 mg) injected into one or two cords in the same hand during the same visit. Finger extension was performed 24, 48, or ?72 hours later. Changes in fixed flexion contracture (FFC) and range of motion (ROM), rates of clinical success (FFC ?5), and adverse events (AEs), were summarized by time of finger extension (24, 48, or ?72 hours).

Results: The study enrolled 715 patients and 725 joint pairs were treated; among these pairs, 268 (37%) had finger extension at 24 hours, 299 (41%) at 48 hours, and 158 (22%) at ?72 hours. A total of 714 patients and 724 joint pairs were analyzed for efficacy. Improvement in FFC and ROM at 30 days post-CCH injection and clinical success rates (Table 1) and the percentage of subjects that experienced ?1 treatment-related AE (Table 2) were similar regardless of time to finger extension. The majority of AEs began on the day of injection or finger extension; most were mild to moderate and resolved without intervention.

Conclusions: The timing of the finger extension procedure did not affect the efficacy or safety of CCH, although numerically, the rate of lacerations appeared lower when finger extension was performed at 72 hours rather than at 24 or 48 hours. The ability to vary the time between CCH injection and finger extension may allow for greater flexibility for both physicians and patients.



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