PDF herunterladen
CC BY-NC-ND 4.0 · Revista Iberoamericana de Cirugía de la Mano 2017; 45(02): 070-088
DOI: 10.1055/s-0037-1608749
Original Article | Artículo Original
Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil

Efficacy of Collagenase Clostridium Histolyticum for Dupuytren Disease: A Systematic Review

Artikel in mehreren Sprachen: English | español
Rafael Sanjuan-Cerveró
1   Department of Orthopedics and Traumatology Surgery, Hospital de Dénia, Alicante, Spain
,
Pedro Vazquez-Ferreiro
2   Department of Ophthalmology, Hospital Virxe da Xunqueira, La Coruña, Spain
,
Diego Gomez-Herrero
3   Pharmacy Service, Hospital 9 de Octubre, Valencia, Spain
,
Francisco Javier Carrera-Hueso
4   Pharmacy Service, Hospital Dr. Moliner, Valencia, Spain
› Institutsangaben
Weitere Informationen

Publikationsverlauf

26. Juli 2017

19. September 2017

Publikationsdatum:
22. November 2017 (online)

   Lizenzen und Reprints

Abstract

Introduction Collagenase Clostridium Histolyticum (CCH) has become a therapeutic alternative for Dupuytren disease. However, its efficacy in the medium to long term is unknown. The objective of our study is to carry out a systematic review of the studies conducted on the subject.

Material and Methods Systematic bibliographic search. Analysis depending on the time of progression, looking into 2 groups with the follow-up cut-off point of 1 year. Analysis of the number of patients who reached the primary endpoint, of the mean correction in degrees, and of the proportional correction of each joint.

Results The 50 selected clinical trials encompass a total of 4,622 patients (an average of 92.70). A total of 7,546 joints were treated with the mean being 148.15 joints per trial (3,925 metacarpophalangeal [MCP] and 2,350 proximal interphalangeal [PIP]). In less than one year of progression, the primary end point was reached in 48.9% of the joints (69.77% of the MCPs and 30.14% of the PIPs), the mean correction in degrees was 45.5 (standard deviation [SD]: 19.18) degrees; 40.8 degrees in the MCP (SD: 10.12) and 35.6 in the PIP (SD: 13.23), and the proportional correction of the joints was 72.9% (SD: 14.43) (83.9% for MCPs [SD: 12.58] and 64.2 for the PIPs [SD: 16.35]). In the follow-ups over 1 year, the primary end point was reached at a rate of 57.5% (68.9% of the MCPs and 43.3% of the PIPs), the mean correction in degrees was 37.6 degrees (SD: 10.93) (37.3 degrees in the MCPs [SD: 9.98] and 23.7 in the PIPs [SD: 16.33]) and the proportional correction of the joints was 87.3% (SD: 10.96) (90.3% for MCP [SD: 6.94] and 75% for PIP [SD: 13.54]).

Conclusions The results indicate a satisfactory response to CCH treatment maintained in the short and medium term. The recurrence rate is uncertain given the available data.

Keywords

collagenase - clostridium histolyticum - efficacy - systematic review
 

  • References

  • 1 Smeraglia F, Del Buono A, Maffulli N. Collagenase clostridium histolyticum in Dupuytren's contracture: a systematic review. Br Med Bull 2016; 118 (01) 149-158
    CrossrefPubMedGoogle Scholar
  • 2 Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am 2011; 36 (05) 936-942
    CrossrefPubMedGoogle Scholar
  • 3 Hueston JT. Enzymic fasciotomy. Hand 1971; 3 (01) 38-40
    CrossrefPubMedGoogle Scholar
  • 4 Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am 2002; 27 (05) 788-798
    CrossrefPubMedGoogle Scholar
  • 5 Badalamente MA, Hurst LC. Enzyme injection as nonsurgical treatment of Dupuytren's disease. J Hand Surg Am 2000; 25 (04) 629-636
    CrossrefPubMedGoogle Scholar
  • 6 Hurst LC, Badalamente MA, Hentz VR. , et al; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med 2009; 361 (10) 968-979
    CrossrefPubMedGoogle Scholar
  • 7 Zhao JZ, Hadley S, Floyd E, Earp BE, Blazar PE. The Impact of Collagenase Clostridium histolyticum Introduction on Dupuytren Treatment Patterns in the United States. J Hand Surg Am 2016; 41 (10) 963-968
    CrossrefPubMedGoogle Scholar
  • 8 Marks M, Krefter C, Herren DB. Treatment Methods for Patients with Dupuytren's Disease in Switzerland. Handchir Mikrochir Plast Chir 2016; 48 (03) 155-160
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 9 Peimer CA, Blazar P, Coleman S. , et al. Dupuytren contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS study): 3-year data. J Hand Surg Am 2013; 38 (01) 12-22
    CrossrefPubMedGoogle Scholar
  • 10 Peimer CA, Blazar P, Coleman S, Kaplan FTD, Smith T, Lindau T. 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. J Hand Surg Am 2015; 40 (08) 1597-1605
    CrossrefPubMedGoogle Scholar
  • 11 Badalamente MA, Hurst LC, Benhaim P, Cohen BM. Efficacy and safety of collagenase clostridium histolyticum in the treatment of proximal interphalangeal joints in dupuytren contracture: combined analysis of 4 phase 3 clinical trials. J Hand Surg Am 2015; 40 (05) 975-983
    CrossrefPubMedGoogle Scholar
  • 12 Witthaut J, Bushmakin AG, Gerber RA, Cappelleri JC, Le Graverand-Gastineau M-PH. Determining clinically important changes in range of motion in patients with Dupuytren's Contracture: secondary analysis of the randomized, double-blind, placebo-controlled CORD I study. Clin Drug Investig 2011; 31 (11) 791-798
    CrossrefPubMedGoogle Scholar
  • 13 Warwick D. Dupuytren's disease: my personal view. J Hand Surg Eur Vol 2017; 42 (07) 665-672
    CrossrefPubMedGoogle Scholar
  • 14 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 (12) 2027-38.e1
    CrossrefPubMedGoogle Scholar
  • 15 Witthaut J, Jones G, Skrepnik N, Kushner H, Houston A, Lindau TR. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies. J Hand Surg Am 2013; 38 (01) 2-11
    CrossrefPubMedGoogle Scholar
  • 16 Warwick D, Arner M, Pajardi G. , et al; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol 2015; 40 (02) 124-132
    CrossrefPubMedGoogle Scholar
  • 17 Gaston RG, Larsen SE, Pess GM. , et al. The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, Multicenter Study. J Hand Surg Am 2015; 40 (10) 1963-1971
    CrossrefPubMedGoogle Scholar
  • 18 Spanholtz TA, Holzbach T, Wallmichrath J. , et al. [Treatment of Dupuytren's contracture by means of injectable collagenase: first clinical experiences]. Handchir Mikrochir Plast Chir Organ Deutschsprachigen Arbeitsgemeinschaft Handchir Organ Deutschsprachigen Arbeitsgemeinschaft Mikrochir Peripher Nerven Gefasse Organ V. 2011; 43 (05) 275-280
    PubMedGoogle Scholar
  • 19 Vollbach FH, Walle L, Fansa H. [Dupuytren's disease - patient satisfaction and functional results one year after partial fasciectomy and injection of collagenase]. Handchir Mikrochir Plast Chir 2013; 45 (05) 258-264
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 20 Muppavarapu RC, Waters MJ, Leibman MI, Belsky MR, Ruchelsman DE. Clinical outcomes following collagenase injections compared to fasciectomy in the treatment of Dupuytren's contracture. Hand (NY) 2015; 10 (02) 260-265
    CrossrefPubMedGoogle Scholar
  • 21 Povlsen B, Povlsen SD. What is the better treatment for single digit dupuytren's contracture: surgical release or collagenase clostridium histolyticum (Xiapex) injection?. Hand Surg 2014; 19 (03) 389-392
    CrossrefPubMedGoogle Scholar
  • 22 Zhou C, Hovius SER, Slijper HP. , et al. Collagenase Clostridium Histolyticum versus Limited Fasciectomy for Dupuytren's Contracture: Outcomes from a Multicenter Propensity Score Matched Study. Plast Reconstr Surg 2015; 136 (01) 87-97
    CrossrefPubMedGoogle Scholar
  • 23 Tay TKW, Tien H, Lim EYL. Comparison between Collagenase Injection and Partial Fasciectomy in the Treatment of Dupuytren's Contracture. Hand Surg 2015; 20 (03) 386-390
    CrossrefPubMedGoogle Scholar
  • 24 Nydick JA, Olliff BW, Garcia MJ, Hess AV, Stone JD. A comparison of percutaneous needle fasciotomy and collagenase injection for dupuytren disease. J Hand Surg Am 2013; 38 (12) 2377-2380
    CrossrefPubMedGoogle Scholar
  • 25 Strömberg J, Ibsen-Sörensen A, Fridén J. Comparison of Treatment Outcome After Collagenase and Needle Fasciotomy for Dupuytren Contracture: A Randomized, Single-Blinded, Clinical Trial With a 1-Year Follow-Up. J Hand Surg Am 2016; 41 (09) 873-880
    CrossrefPubMedGoogle Scholar
  • 26 Scherman P, Jenmalm P, Dahlin LB. One-year results of needle fasciotomy and collagenase injection in treatment of Dupuytren's contracture: A two-centre prospective randomized clinical trial. J Hand Surg Eur Vol 2016; 41 (06) 577-582
    CrossrefPubMedGoogle Scholar
  • 27 Skov ST, Bisgaard T, Søndergaard P, Lange J. Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial. J Hand Surg Am 2017; 42 (05) 321-328.e3
    CrossrefPubMedGoogle Scholar
  • 28 Sanjuan Cerveró R, Franco Ferrando N, Poquet Jornet J. Use of resources and costs associated with the treatment of Dupuytren's contracture at an orthopedics and traumatology surgery department in Denia (Spain): collagenase clostridium hystolyticum versus subtotal fasciectomy. BMC Musculoskelet Disord 2013; 14 (01) 293
    CrossrefPubMedGoogle Scholar
  • 29 Murphy LE, Murphy KM, Kilpatrick SM, Thompson NW. The use of Collagenase Clostridium Histolyticum in the management of Dupuytren's contracture-outcomes of a pilot study in a District General Hospital setting. Ulster Med J 2017; 86 (02) 94-98
    PubMedGoogle Scholar
  • 30 Sood A, Therattil PJ, Paik AM, Simpson MF, Lee ES. Treatment of dupuytren disease with injectable collagenase in a veteran population: a case series at the department of veterans affairs new jersey health care system. Eplasty 2014; 14: e13
    PubMedGoogle Scholar
  • 31 Waters MJ, Belsky MR, Blazar PE, Leibman MI, Ruchelsman DE. Collagenase enzymatic fasciotomy for Dupuytren contracture in patients on chronic immunosuppression. Am J Orthop 2015; 44 (11) 518-521
    PubMedGoogle Scholar
  • 32 Skirven TM, Bachoura A, Jacoby SM, Culp RW, Osterman AL. The effect of a therapy protocol for increasing correction of severely contracted proximal interphalangeal joints caused by dupuytren disease and treated with collagenase injection. J Hand Surg Am 2013; 38 (04) 684-689
    CrossrefPubMedGoogle Scholar
  • 33 Leclère F-M, Mathys L, Vögelin E. [Collagenase injection in Dupuytren's disease, evaluation of the ultrasound assisted technique]. Chir Main 2014; 33 (03) 196-203
    CrossrefPubMedGoogle Scholar
  • 34 Bear BJ, Peimer CA, Kaplan FTD, Kaufman GJ, Tursi JP, Smith T. Treatment of Recurrent Dupuytren Contracture in Joints Previously Effectively Treated With Collagenase Clostridium histolyticum. J Hand Surg Am 2017; 42 (05) 391.e1-391.e8
    CrossrefPubMedGoogle Scholar
  • 35 McMahon HA, Bachoura A, Jacoby SM, Zelouf DS, Culp RW, Osterman AL. Examining the efficacy and maintenance of contracture correction after collagenase clostridium histolyticum treatment for Dupuytren's disease. Hand (NY) 2013; 8 (03) 261-266
    CrossrefPubMedGoogle Scholar
  • 36 Peimer CA, Skodny P, Mackowiak JI. Collagenase clostridium histolyticum for dupuytren contracture: patterns of use and effectiveness in clinical practice. J Hand Surg Am 2013; 38 (12) 2370-2376
    CrossrefPubMedGoogle Scholar
  • 37 Haerle M, Witthaut J, Giunta RE. , et al. Treatment of Dupuytreńs contracture with collagenase clostridium histolyticum under clinical practice conditions: ReDUCTo study. Ger Plast Reconstr Aesthet Surg 2015; 5: Doc06
    PubMedGoogle Scholar
  • 38 Warwick DJ, Graham D, Worsley P. New insights into the immediate outcome of collagenase injections for Dupuytren's contracture. J Hand Surg Eur Vol 2016; 41 (06) 583-588
    CrossrefPubMedGoogle Scholar
  • 39 Verheyden JR. Early outcomes of a sequential series of 144 patients with Dupuytren's contracture treated by collagenase injection using an increased dose, multi-cord technique. J Hand Surg Eur Vol 2015; 40 (02) 133-140
    CrossrefPubMedGoogle Scholar
  • 40 Mickelson DT, Noland SS, Watt AJ, Kollitz KM, Vedder NB, Huang JI. Prospective randomized controlled trial comparing 1- versus 7-day manipulation following collagenase injection for dupuytren contracture. J Hand Surg Am 2014; 39 (10) 1933-1941.e1
    CrossrefPubMedGoogle Scholar
  • 41 Manning CJ, Delaney R, Hayton MJ. Efficacy and tolerability of Day 2 manipulation and local anaesthesia after collagenase injection in patients with Dupuytren's contracture. J Hand Surg Eur Vol 2014; 39 (05) 466-471
    CrossrefPubMedGoogle Scholar
  • 42 Kaplan FTD, Badalamente MA, Hurst LC, Merrell GA, Pahk R. Delayed manipulation after collagenase clostridium histolyticum injection for Dupuytren contracture. Hand (NY) 2015; 10 (03) 578-582
    CrossrefPubMedGoogle Scholar
  • 43 Mármol-Soler S, Espejo-Ortega L, Gutiérrez-Ortega C. , et al. Tratamiento no quirúrgico de la contractura de Dupuytren con colagenasa de Clostridium hystoliticum. Cir Plástica Ibero-Latinoam. 2013; 39 (03) 247-254
    PubMedGoogle Scholar
  • 44 Alberton F, Corain M, Garofano A. , et al. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren contracture: report of 40 cases. Musculoskelet Surg 2014; 98 (03) 225-232
    CrossrefPubMedGoogle Scholar
  • 45 Martín-Ferrero MÁ, Simón-Pérez C, Rodríguez-Mateos JI, García-Medrano B, Hernández-Ramajo R, Brotat-García M. Treatment of Dupuytren's disease using collagenase from Clostridium histolyticum. Rev Esp Cir Ortop Traumatol 2013; 57 (06) 398-402
    PubMedGoogle Scholar
  • 46 Coleman S, Gilpin D, Kaplan FTD. , et al. Efficacy and safety of concurrent collagenase clostridium histolyticum injections for multiple Dupuytren contractures. J Hand Surg Am 2014; 39 (01) 57-64
    CrossrefPubMedGoogle Scholar
  • 47 Atroshi I, Nordenskjöld J, Lauritzson A, Ahlgren E, Waldau J, Waldén M. Collagenase treatment of Dupuytren's contracture using a modified injection method: a prospective cohort study of skin tears in 164 hands, including short-term outcome. Acta Orthop 2015; 86 (03) 310-315
    CrossrefPubMedGoogle Scholar
  • 48 Lauritzson A, Atroshi I. Collagenase injections for Dupuytren's disease: prospective cohort study assessing 2-year treatment effect durability. BMJ Open 2017; 7 (03) e012943
    CrossrefPubMedGoogle Scholar
  • 49 Grandizio LC, Akoon A, Heimbach J, Graham J, Klena JC. The Use of Residual Collagenase for Single Digits With Multiple-Joint Dupuytren Contractures. J Hand Surg Am 2017; 42 (06) 472.e1-472.e6
    CrossrefPubMedGoogle Scholar
  • 50 Odinsson A, Brenne LE, Lurie TB, Finsen V. Dupuytren's Contracture. The Safety and Efficacy of Collagenase Treatment. J Hand Surg Asian Pac Vol 2016; 21 (02) 187-192
    PubMedGoogle Scholar
  • 51 Binter A, Neuwirth M, Rab M. [Treatment of Dupuytren's disease with collagenase - a 1-year follow-up of 37 patients]. Handchir Mikrochir Plast Chir 2014; 46 (06) 355-360
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 52 Considine S, Heaney R, Hirpara KM. Early results of the use of collagenase in the treatment of Dupuytren's contracture. Ir J Med Sci 2015; 184 (02) 323-327
    CrossrefPubMedGoogle Scholar
  • 53 Pérez-Giner RA, Aguilella L. Resultado precoz del tratamiento de la enfermedad de Dupuytren mediante inyección de colagenasa. Rev Iberoam Cir Mano. 2015; 43 (01) 13-19
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 54 Hirata H, Tanaka K, Sakai A, Kakinoki R, Ikegami H, Tateishi N. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population. J Hand Surg Eur Vol 2016; 1753193416653249
    PubMedGoogle Scholar
  • 55 Verstreken F, Degreef I, Decramer A. , et al. Effectiveness and safety of collagenase Clostridium histolyticum in Dupuytren's disease : an observational study in Belgium. Acta Orthop Belg 2016; 82 (02) 397-404
    PubMedGoogle Scholar
  • 56 European Medicines Agency - Find medicine - Xiapex.
    PubMed
  • 57 Coleman S, Gilpin D, Tursi J, Kaufman G, Jones N, Cohen B. Multiple concurrent collagenase clostridium histolyticum injections to Dupuytren's cords: an exploratory study. BMC Musculoskelet Disord 2012; 13 (01) 61
    CrossrefPubMedGoogle Scholar
  • 58 Arora R, Kaiser P, Kastenberger T-J, Schmiedle G, Erhart S, Gabl M. Injectable collagenase Clostridium histolyticum as a nonsurgical treatment for Dupuytren's disease. Oper Orthop Traumatol 2016; 28 (01) 30-37
    CrossrefPubMedGoogle Scholar
  • 59 Hansen KL, Werlinrud JC, Larsen S, Ipsen T, Lauritsen J. Difference in Success Treating Proximal Interphalangeal and Metacarpophalangeal Joints with Collagenase: Results of 208 Treatments. Plast Reconstr Surg Glob Open 2017; 5 (04) e1275
    CrossrefPubMedGoogle Scholar
  • 60 Keller M, Arora R, Schmiedle G, Kastenberger T. Therapie des Morbus Dupuytren mit Kollagenase Clostridium histolyticum. Orthop 2017; 1 (07) 321-327
    PubMedGoogle Scholar
  • 61 Malafa MM, Lehrman C, Criley JW, Amirlak B. Collagenase Dupuytren Contracture: Achieving Single Treatment Success with a Hand Therapist-Based Protocol. Plast Reconstr Surg Glob Open 2016; 4 (02) e629
    CrossrefPubMedGoogle Scholar
  • 62 Rodrigues JN, Zhang W, Scammell BE, Davis TR. Dynamism in Dupuytren's contractures. J Hand Surg Eur Vol 2015; 40 (02) 166-170
    CrossrefPubMedGoogle Scholar
  • 63 Sanjuan-Cerveró R, Carrera-Hueso FJ, Vazquez-Ferreiro P, Gomez-Herrero D. Adverse Effects of Collagenase in the Treatment of Dupuytren Disease: A Systematic Review. BioDrugs 2017; 31 (02) 105-115
    CrossrefPubMedGoogle Scholar
  • 64 García-Olea A, Dudley AF, Gimeno Andrade MD, Ocampos M, Fahandezh-Saddi H, Del Cerro M. Efectividad del tratamiento de la enfermedad de Dupuytren (ED) mediante fasciotomía enzimática con colagenasa. Estudio multicéntrico cohortes prospectivo. Rev Iberoam Cir Mano. 2014; 42: 97-106
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 65 Peimer CA, McGoldrick CA, Kaufman G. Nonsurgical Treatment of Dupuytren Contracture: 3-Year Safety Results Using Collagenase Clostridium histolyticum. J Hand Surg Am 2013; 38 (10) e52
    PubMedGoogle Scholar