Postapproval clinical experience in the treatment of Dupuytren’s contracture with collagenase clostridium histolyticum (CCH): the first 1,000?days

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• 作者：Scott M. Schulze (1)
  James P. Tursi (2)
  
• 关键词：Collagen ; Collagenase clostridium histolyticum ; Contracture ; Dupuytren ; Hand ; Nonsurgical treatment
• 刊名：HAND
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：9
• 期：4
• 页码：447-458
• 全文大小：923 KB
• 参考文献：1. American Society for Surgery of the Hand. Level of evidence guidelines. Available at: http://www.assh.org. Accessed 6 Jul 2012.
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  3. Auxilium Pharmaceuticals Inc. BLA 125338 Xiaflex? (collagenase clostridium histolyticum) risk evaluation and mitigation strategy (REMS). Malvern, PA: Auxilium Pharmaceuticals, Inc.; February, 2012.
  4. Auxilium Pharmaceuticals Inc. Xiaflex? (collagenase clostridium histolyticum) [prescribing information]. Malvern, PA: Auxilium Pharmaceuticals, Inc.; December, 2013.
  5. Beaudreuil J, Lellouche H, Orcel P, Bardin T. Needle aponeurotomy in Dupuytren’s disease. Joint Bone Spine. 2012;79:13-. CrossRef
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  9. Coleman S, Gilpin D, Kaplan FT, Houston A, Kaufman GJ, Cohen BM, et al. Efficacy and safety of concurrent collagenase clostridium histolyticum injections for multiple Dupuytren contractures. J Hand Surg [Am]. 2014;39:57-4. CrossRef
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  11. Couceiro J, Savvidou C, Kaufman CL, Moreno R, Tien HY. Effect of joint contracture on patient satisfaction in collagenase injection treatment of Dupuytren’s disease. Presented at: 67th Annual Meeting of the American Society for Surgery of the Hand, September 6-, 2012, Chicago, IL.
  12. Curtin C, Cohen B. Dupuytren’s contracture recurrence after treatment with collagenase clostridium histolyticum diathesis and other disease factors. Presented at: American Association for Hand Surgery, January 9-2, 2013, Naples, FL.
  13. De Salas-Cansado M, Cuadros M, Del CM, Arandes JM. Budget impact analysis in Spanish patients with Dupuytren’s contracture: fasciectomy vs. collagenase clostridium histolyticum. Chir Main. 2013;32:68-3. main.2013.02.012" target="_blank" title="It opens in new window">CrossRef
  14. DeMarco PJ, Beall AD, Matsumoto AK, Baraf HSB, Mandel DR. Retrospective review of the use of ultrasound guidance while injecting collagenase clostridium histolyticum (Xiaflex?) into a Dupuytren’s cord. Presented at: Annual Meeting of the American Association for Hand Surgery, January 9-2, 2013, Naples, FL.
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• 作者单位：Scott M. Schulze (1)
  James P. Tursi (2)
  
  1. Delmarva Hand Specialists, 34434 King Street Row, Suite 2, Lewes, DE, 19958, USA
  2. Clinical Development, Auxilium Pharmaceuticals, 640 Lee Road, Chesterbrook, PA, 19087, USA
  
• ISSN：1558-9455

文摘

Dupuytren’s contracture is a benign fibromatosis of the palmar and digital fascia of the hand of uncertain etiology, resulting in nodules and cords beneath the skin of the palm of the hands that may lead to the development of contractures. Surgical intervention is often considered when metacarpophalangeal (MP) joint contracture is 30° or more, or when there is any degree of proximal interphalangeal (PIP) joint contracture. Collagenase clostridium histolyticum (CCH) is a nonsurgical, minimally invasive enzymatic drug indicated for the treatment of adult patients with Dupuytren’s contracture (DC) and palpable cord. CCH has been available for approximately 3.5?years, and postapproval experience indicates that the effectiveness of CCH is equivalent to or better than efficacy observed in clinical trials, as seen by lower injection rates to achieve clinical success. Postapproval experience has shown a risk-benefit profile that favors CCH for patients not indicated for surgery based on current recommendations and shows also that treating earlier-stage vs later-stage joint contracture results in significantly better outcomes on average. Postapproval surveillance reveals a safety profile similar to that observed in clinical trials. Nonserious adverse events are mainly local reactions; tendon rupture, a serious adverse event, is reported rarely in the clinical practice setting and at a lower rate than in clinical trials. Risk Evaluation and Mitigation Strategy (REMS) training is designed to mitigate benefit vs risk to achieve safe and effective use of CCH.