Skip to main content
SpringerLink
Log in

Nonsurgical treatment of Dupuytren’s contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum

  • Surgery Articles
  • Published:
HAND

Abstract

Background

Collagenase clostridium histolyticum (CCH) is a Food and Drug Administration-approved treatment for adult patients with Dupuytren’s contracture with a palpable cord that has been shown efficacious and safe in clinical trials.

Methods

This paper summarizes the most common post-marketing clinical adverse event (AE) reports received by the manufacturer of CCH and sponsor of the US Biologics License Application (Auxilium Pharmaceuticals, Malvern, PA, USA) during the first 12 months after drug approval and commercialization in the USA.

Results

Of the 115 AE reports describing 270 AEs voluntarily received from patients or health care providers after approximately 5,400 injections of CCH administered, the most common AEs involved local, nonserious reactions to treatment, including skin tears, peripheral edema, and contusion. There were few serious AEs observed (0.6% reporting rate per 1,000 injections), and two flexor tendon ruptures and one flexor pulley injury were reported.

Conclusions

Analysis of post-marketing AEs received for CCH in the first year post-approval supports the safety profile reported earlier during clinical development and did not reveal additional clinical risks or concerns about CCH.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med. 2003;18:57–60.

    Article  PubMed  Google Scholar 

  2. Auxilium Pharmaceuticals Inc. AAC briefing document for collagenase clostridium histolyicum. Malvern, PA: Auxilium Pharmaceuticals, Inc.; September 16, 2009.

  3. Chen NC, Srinivasan RC, Shauver MJ, Chung KC. A systematic review of outcomes of fasciotomy, aponeurotomy, and collagenase treatments for Dupuytren’s contracture. Hand. 2011;6:250–5.

    Article  Google Scholar 

  4. Chigot PL. Foreword: Baron Dupuytren. In: Hueston JT, Tubiana R, editors. Dupuytren’s disease. New York: Grune & Stratton; 1974. ix–x.

  5. Cooper A. A treatise on dislocations and fractures of the joints. London: Churchill; 1842.

    Google Scholar 

  6. Denkler K. Surgical complications associated with fasciectomy for Dupuytren’s disease: a 20-year review of the English literature. J Plast Surg. 2010;10:116–33.

    Google Scholar 

  7. Desai SS, Hentz VR. Collagenase clostridium histolyticum for Dupuytren’s contracture. Expert Opin Biol Ther. 2010;10:1395–404.

    Article  PubMed  CAS  Google Scholar 

  8. Elliot D. The early history of contracture of the palmar fascia. Part 2: the revolution in Paris: Guillaume Dupuytren: Dupuytren’s disease. J Hand Surg Eur. 1988;13:371–8.

    Article  CAS  Google Scholar 

  9. French MF, Mookhtiar KA, Van Wart HE. Limited proteolysis of type I collagen at hyperreactive sites by class I and II Clostridium histolyticum collagenases: complementary digestion patterns. Biochemistry. 1987;26:681–7.

    Article  PubMed  CAS  Google Scholar 

  10. 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;35A:2027–2083.e1.

    Article  Google Scholar 

  11. Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, et al. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. N Engl J Med. 2009;361:968–79.

    Article  PubMed  CAS  Google Scholar 

  12. Hutchison RL, Rayan GM. Astley Cooper: his life and surgical contributions. J Hand Surg Am. 2011;36:316–20.

    Article  PubMed  Google Scholar 

  13. Starkweather KD, Lattuga S, Hurst LC, Badalamente MA, Guilak F, Sampson SP, et al. Collagenase in the treatment of Dupuytren’s disease: an in vitro study. J Hand Surg Am. 1996;21:490–5.

    Article  PubMed  CAS  Google Scholar 

  14. Zhang AY, Curtin CM, Hentz VR. Flexor tendon rupture after collagenase injection for Dupuytren contracture: case report. J Hand Surg Am. 2011;36:1323–5.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The authors wish to thank Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. Funding for this study and support in the preparation of this manuscript was provided by Auxilium Pharmaceuticals. This manuscript was prepared according to the International Society for Medical Publication Professionals’ Good Publication Practice for Communicating Company-Sponsored Medical Research: the GPP2 Guidelines.

Conflict of interest

C. A. P. is a consultant for Auxilium Pharmaceuticals, from which he has received honoraria and reimbursement for travel and accommodation expenses. G. J. F’s employer, SSI Strategy, has received consulting fees or honoraria and travel and expenses reimbursement from Auxilium Pharmaceuticals, where he served as a safety consultant. C. A. M. is an employee of Auxilium Pharmaceuticals, where she is the Director of Drug Safety.

Author information

Authors and Affiliations

  1. College of Human Medicine, Michigan State University, Hand Surgery Office, 1414 W. Fair Avenue, Suite 249, Marquette, MI, 49855, USA

    C. A. Peimer

  2. SSI Strategy, 515 Trinity Place, Unit 1CN, Westfield, NJ, 07090, USA

    G. J. Fiore

  3. Auxilium Pharmaceuticals, 40 Valley Stream Parkway, Malvern, PA, 19355, USA

    C. A. McGoldrick

Authors
  1. C. A. Peimer
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. C. A. McGoldrick
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. G. J. Fiore
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to C. A. Peimer.

About this article

Cite this article

Peimer, C.A., McGoldrick, C.A. & Fiore, G.J. Nonsurgical treatment of Dupuytren’s contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum. HAND 7, 143–146 (2012). https://doi.org/10.1007/s11552-012-9407-3

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11552-012-9407-3

Keywords

Search

Navigation