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Real-World Data Reinforce Clinical Efficacy Of Xiapex® In The Treatment Of Dupuytren’s Contracture

New analysis of recurrence data at three years shows treatment response following Xiapex can be maintained at three years

Real-world data from clinical practice, presented last week at the annual congress of the Federation of European Societies for Surgery of the Hand (FESSH), show that Xiapex® ( clostridium histolyticum) improved the degree of ’s contracture by 36.6 ± 20.3 degrees (n=546 joints) with an 84% improvement in range of motion.1 These results are in line with those seen in the pivotal CORD I study1,2 and further support the role of collagenase clostridium histolyticum (CCH) as a minimally invasive option in the treatment of ’s contracture in adult patients with a palpable cord.3

The retrospective chart review of 501 US patient charts, representing 629 unique joints, examined the effectiveness of CCH for Dupuytren’s contracture in a real-world setting, compared to efficacy findings from the clinical registration trial (CORD-I). The number of CCH injections per joint was 1.08 ± 0.32 (n=629 joints) and the average number of office visits/treatment was 2.92 ± 1.0 (n=620).1 Both of these figures are lower than those seen in the phase III study, where the mean number of CCH injections per joint was 1.5 (CI 1.39-1.61).1

Dr Gary Pess, Orthopaedic Surgeon at the Drexel University School of Medicine, Philadelphia, PA and Central Jersey Hand Surgery Eatontown, , , explained, “This data supports collagenase clostridium histolyticum as a viable alternative, in some patients, to invasive surgical options currently available. It is good to hear that treatment outcomes can be achieved with fewer injections and visits than seen in clinical trials, and this could potentially lead to a positive impact on healthcare costs associated with Dupuytren’s contracture treatment in some countries”.

Also presented at FESSH are results from a separate ongoing study, investigating with CCH in patients with Dupuytren’s contracture.4 Recurrence was defined as an increase in contracture of ≥20° and finding of palpable cord, or the joint receiving further medical/surgical treatment.4

The analysis showed that three years after successful treatment with CCH (improvement in contracture to 0-5 degrees), recurrence across the 623 joints achieving clinical success was 35%, as reported earlier this year. 5 Approximately 7% of joints underwent medical (CCH) or surgical intervention for recurrence by Year 3. 4 In addition, the proximal interphalangeal (PIP) joints that had lower baseline severity also demonstrated a lower than those with more severe contracture (50% low v 71% high).4 No new long-term adverse events or serious adverse events related to previous collagenase clostridium histolyticum treatment were observed.4

This analysis is part of a prospective, five year follow-up study (CORDLESS) involving 602 patients (1,080 joints) who received one or more CCH injections and one or more post-treatment assessments during any of the five phase III CCH clinical studies.4 Date of prep: June 2012 EUXPX-12-40

Commenting on the results of this data, Jarkko Vasenius, M.D. Ph.D., Senior Consulting Hand Surgeon at the Dextra Hand Clinic in Helsinki, Finland, noted, “Low recurrence rates (26.6%) especially in the metacarpophalangeal (MP) joints that achieved clinical success are very encouraging. Treatment of severe PIP contractures by any method is always very challenging with low clinical success and high recurrence rates.”

Xiapex (collagenase clostridium histolyticum) is the first pharmaceutical treatment approved in the EU for the treatment of Dupuytren’s contracture in adult patients with a palpable cord.3 Xiapex (collagenase clostridium histolyticum) already has a proven efficacy and a favourable safety profile.3

Source

1 Pess G, Peimer CA, Skodny P, et al. Efficacy and effectiveness of collagenase clostridium histolyticum for Dupuytren’s contracture: Comparison of real-world data with clinical trial results. FESSH 2012.

2 Hurst LC, Badalamente MA, Hentz VR et al. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture (CORD I). NEJM 2003; 361: 968-79

3 European Medicines Agency. XIAPEX® EPAR – Product Information. Available here.

4 Boeckstyns M, Boyce D, Vasenius J, et al. Recurrence rates in patients with Dupuytren’s contracture 3 years after successful treatment with collagenase clostridium histolyticum. FESSH 2012.

5 Boyce D, Boeckstyns M, Vasenius J, et al. Three-Year Recurrence Rates of Dupuytren’s Contracture Following Successful Collagenase Clostridium Histolyticum Treatment. Oral presentation at 13th European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress, 2012.

6 Hindocha S, McGrouther DA and Bayat A. Epidemiological evaluation of Dupuytren’s disease incidence and prevalence rates in relation to etiology. Hand (NY) 2009; 4(3): 256-69

7 Godtfredsen NS, Lucht H, Prescott E, et al. A prospective study linked both alcohol and tobacco to Dupuytren’s disease. J Clin Epidemiol 2004; 57(8): 858-863

8 Finsen V, Dalen H, Nesheim J. The prevalence of Dupuytren’s disease among 2 different ethnic groups in northern Norway. J Hand Surg [Am] 2002; 27(1): 115-117

9 Attali P, Ink O, Pelletier G, et al. Dupuytren’s contracture, alcohol consumption, and chronic liver disease. Arch Intern Med 1987; 147(6): 1065-1067

10 Bergenudd H, Lindgarde F, Nilsson BE. Prevalence of Dupuytren’s contracture and its correlation with degenerative changes of the hands and feet and with criteria of general health. J Hand Surg [Br] 1993; 18(2): 254-257

11 Crean SM, Gerber RA, Hellio Le Graverand MP, et al. The efficacy and safety of fasciectomy and fasciotomy for Dupuytren’s contracture in European patients: a structured review of published studies. J Hand Surg (Eur) Published online 7 March 2011

12 Gudmundsson KG, et al. Epidemiology of Dupuytren’s disease: clinical, serological, and social assessment. The Reykjavik Study. J Clin Epidemiology 2000; 53: 291-6

13 Townley WA, et al. Dupuytren’s contracture unfolded. BMJ 2006; 332: 397-400

14 Bayat A and McGrouther DA. Management of Dupuytren’s disease – clear advice for an elusive condition. Ann R Coll Surg Engl 2006; 88: 3-8

15 Kantar Health Dupuytren’s Patient Journey Study 2010/2011. 1,392 Patients aged 18+ years old across 9 European countries

16 US Food and Drug Administration press release, 2nd February 2010.