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Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium Histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data

      Purpose

      Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study was a 5-year noninterventional follow-up study to determine long-term efficacy and safety of collagenase clostridium histolyticum (CCH) treatment for Dupuytren contracture.

      Methods

      Patients from previous CCH clinical studies were eligible. Enrolled patients were evaluated annually for contracture and safety at 2, 3, 4, and 5 years after their first injection (0.58 mg) of CCH. In successfully treated joints (≤ 5° contracture following CCH treatment), recurrence was defined as 20° or greater worsening (relative to day 30 after the last injection) with a palpable cord or any medical/surgical intervention to correct new/worsening contracture. A post hoc analysis was also conducted using a less stringent threshold (≥ 30° worsening) for comparison with criteria historically used to assess surgical treatment.

      Results

      Of 950 eligible patients, 644 enrolled (1,081 treated joints). At year 5, 47% (291 of 623) of successfully treated joints had recurrence (≥ 20° worsening)—39% (178 of 451) of metacarpophalangeal and 66% (113 of 172) of proximal interphalangeal joints. At year 5, 32% (198 of 623) of successfully treated joints had 30° or greater worsening (metacarpophalangeal 26% [119 of 451] and proximal interphalangeal 46% [79 of 172] joints). Of 105 secondary interventions performed in the successfully treated joints, 47% (49 of 105) received fasciectomy, 30% (32 of 105) received additional CCH, and 23% (24 of 105) received other interventions. One mild adverse event was attributed to CCH treatment (skin atrophy [decreased ring finger circumference from thinning of Dupuytren tissue]). Antibodies to clostridial type I and/or II collagenase were found in 93% of patients, but over the 5 years of follow-up, this did not correspond to any reported clinical adverse events.

      Conclusions

      Five years after successful CCH treatment, the overall recurrence rate of 47% was comparable with published recurrence rates after surgical treatments, with one reported long-term treatment-related adverse event. Collagenase clostridium histolyticum injection proved to be an effective and safe treatment for Dupuytren contracture. For those receiving treatment during follow-up, both CCH and fasciectomy were elected options.

      Type of study/level of evidence

      Therapeutic II.

      Key words

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      References

        • Rayan G.M.
        Dupuytren's disease: anatomy, pathology, presentation, and treatment.
        J Bone Joint Surg Am. 2007; 89: 189-198
        • Bayat A.
        • Cunliffe E.J.
        • McGrouther D.A.
        Assessment of clinical severity in Dupuytren's disease.
        Br J Hosp Med. 2007; 68: 604-609
        • DiBenedetti D.B.
        • Nguyen D.
        • Zografos L.
        • Ziemiecki R.
        • Zhou X.
        Prevalence, incidence, and treatments of Dupuytren's disease in the United States: results from a population-based study.
        Hand (N Y). 2011; 6: 149-158
        • Werker P.M.N.
        • Pess G.M.
        • van Rijssen A.L.
        • Denkler K.
        Correction of contracture and recurrence rates of Dupuytren contracture following invasive treatment: the importance of clear definitions.
        J Hand Surg Am. 2012; 37: 2095-2105
        • Kan H.J.
        • Verrijp F.W.
        • Huisstede B.M.
        • Hovius S.E.
        • van Nieuwenhoven C.A.
        • Selles R.W.
        The consequences of different definitions for recurrence of Dupuytren's disease.
        J Plast Reconstr Aesthet Surg. 2012; 66: 95-103
        • Xiaflex (collagenase clostridium histolyticum)
        Prescribing information.
        Auxilium Pharmaceuticals, Inc., Chesterbrook, PAOctober 2014
        • Xiapex (collagenase clostridium histolyticum)
        Prescribing information.
        Auxilium UK Limited, Windsor, UKApril 2013
      1. European Medicines Agency. EPAR summary for the public: Xiapex (collagenase clostridium histolyticum). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002048/WC500103377.pdf. Accessed March 11, 2015.

        • Hurst L.C.
        • Badalamente M.A.
        • Hentz V.R.
        • et al.
        Injectable collagenase clostridium histolyticum for Dupuytren's contracture.
        N Engl J Med. 2009; 361: 968-979
        • Gilpin D.
        • Coleman S.
        • Hall S.
        • Houston A.
        • Karrasch J.
        • Jones N.
        Injectable collagenase clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease.
        J Hand Surg Am. 2010; 35: 2027-2038
        • Peimer C.A.
        • Blazar P.
        • Coleman S.
        • et al.
        Dupuytren's contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS): 3-year data.
        J Hand Surg Am. 2013; 38: 12-22
        • Witthaut J.
        • Jones G.
        • Skrepnik N.
        • Kushner H.
        • Houston A.
        • Lindau T.R.
        Efficacy and safety of collagenase clostridium histolyticum, a nonsurgical treatment for adults with Dupuytren's contracture: short-term results from two open-label studies, in the US (JOINT I) and Australia and Europe (JOINT II).
        J Hand Surg Am. 2013; 38: 2-11
        • Smith A.C.
        Diagnosis and indications for surgical treatment.
        Hand Clin. 1991; 7: 635-642
        • van Rijssen A.L.
        • Werker P.M.N.
        Percutaneous needle fasciotomy in Dupuytren's disease.
        J Hand Surg Eur Vol. 2006; 31: 498-501
        • van Rijssen A.L.
        • ter Linden H.
        • Werker P.M.N.
        Five-year results of randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy.
        Plast Reconstr Surg. 2012; 129: 469-477
        • Mafi R.
        • Hindocha S.
        • Khan W.
        Recent surgical and medical advances in the treatment of Dupuytren's disease—a systematic review of the literature.
        Open Orthop J. 2012; 6: 77-82
        • Desai S.S.
        • Hentz V.R.
        The treatment of Dupuytren disease.
        J Hand Surg Am. 2011; 36: 936-942
        • Peimer C.A.
        • Wilbrand S.
        • Gerber R.A.
        • Chapman D.
        • Szczypa P.P.
        Safety and tolerability of collagenase clostridium histolyticum and fasciectomy for Dupuytren's contracture.
        J Hand Surg Eur Vol. 2015; 40: 141-149
        • Peimer C.A.
        • McGoldrick C.A.
        • Kaufman G.
        Nonsurgical treatment of Dupuytren's contracture: 3 year safety results using collagenase clostridium histolyticum.
        J Hand Surg Am. 2013; 38 ([abstract]): e52
        • Tubiana R.
        Surgical treatment.
        in: Tubiana R. The Hand. WB Saunders, Philadelphia1999: 451-483

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