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Efficacy and Effectiveness of Collagenase Clostridium Histolyticum for Dupuytren's Contracture
Clayton A. Peimer, MD1; Paul Skodny, PharmD2; John Mackowiak, PhD3
1College of Human Medicine, Michigan State University, Marquette, MI; 2Health Economics and Outcomes Research, Medical Affairs, Auxilium Pharmaceuticals, Malvern, PA; 3Center for Outcomes Research, Nashville, TN

Objectives: The objective was to determine if the effectiveness of collagenase clostridium histolyticum (XIAFLEX, CCH) in real-world settings is comparable to the efficacy demonstrated in the clinical trials.

Methods: A retrospective chart review was conducted at selected sites. Charts of each patient treated with CCH in 2010 were abstracted. Effectiveness results were compared to efficacy findings from the clinical registration trial (CORD-I)1 on 1) final contracture angle, 2) change in contracture,  3) final range of motion, and 4)change in range of motion, with means of 12°, 38°, 81°, and 37° respectively. The equivalence range was set at +/- 10°.

Results: 501 patient charts were abstracted from 10 sites. The average patient age was 65 years; 76% were male. The 95% confidence interval (C.I.) fell within the corresponding predefined equivalence range of +/- 10° for each of the 4 effectiveness measures (with means of 12°, 37°, 81°, and 37° respectively.)

The effectiveness injections/joint rate was 1.080.32(n=629 joints) with a 95% C.I. of 1.05 to 1.11, This CI does not fall within the  reported C.I. of 1.6 to 1.8 in published trials (p<0.05). The average number of (injection, manipulation, and follow-up) office visits/injection was 2.921.05 (n=620).

Conclusions:

  • CCH effectiveness findings were equivalent to those published for the CORD-I clinical trial, yet the effectiveness injections/joint rate was 36% lower than in the trial.
  • Visits per injection cycle were also lower than in the published CORD-I trial. 
  • The number of CCH injections used in real-world settings may be lower because (a) both patient/physician knew that active drug was administered, (b) anesthesia was used at manipulation, (c) patient focused treatment outcomes were used without the strict requirements of a clinical trial protocol.
  • Reducing CCH injections and visits while maintaining outcomes has significant positive implications for patients, payers, and providers. 

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