Efficacy and Safety of Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture: Short-Term Results From 2 Open-Label Studies

Witthaut, J.; Jones, Graeme; Skrepnik, Nebojša; Kushner, Harvey; Houston, Anthony; Lindau, Tommy

doi:10.1016/j.jhsa.2012.10.008

Cited by 122 publications

(121 citation statements)

References 25 publications

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“…77,80,83 One case series involved consecutive enrolment of study participants, 83 two did not 48,88 and the remaining 12 case series did not provide this information. [77][78][79][80][81][84][85][86][87][89][90][91] Four collagenase versus placebo RCTs were conducted in the USA, 55,[63][64][65] and one was conducted in Australia. 56 Two of the surgical RCTs took place in the UK 67,68 and one in the Netherlands.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…71,72 Of the surgery non-randomised studies, one was conducted in several countries, 73 one in the UK, 74 one in Brazil, 57 one in the USA 75 and one in Australia. 76 Nine of the collagenase case series were conducted in the USA 48,77,81,83,[85][86][87][88][89] two in Australia, 78,79 one in the UK, 91 one in Spain, 84 one in several countries, 90 and the remaining one did not report this information. 63 The non-randomised studies comparing collagenase with surgery enrolled and analysed a total of 105 participants.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…48,78,79,[84][85][86][87][88][89][90][91] Secondary reports 81-83 and abstracts 77,80 were not assessed. The majority of studies included a representative population, collected data prospectively, clearly defined the intervention, administered the collagenase injection in an appropriate setting by someone experienced at performing the procedure, and identified important prognostic factors.…”

Section: Case Series Studiesmentioning

confidence: 99%

“…The majority of studies included a representative population, collected data prospectively, clearly defined the intervention, administered the collagenase injection in an appropriate setting by someone experienced at performing the procedure, and identified important prognostic factors. Three studies, 78,90,91 however, included a mixed patient population (i.e. participants with primary disease and with disease recurrence).…”

Section: Case Series Studiesmentioning

confidence: 99%

“…In about half of the studies (54.6%), follow-up periods were not adequate (< 1 year) and the majority (72.7%) failed to provide information on the characteristics of participants who withdrew or did not complete follow-up. All studies were sponsored by Auxilium Pharmaceuticals 48,78,79,84,[86][87][88][89][90][91] or had a potential conflict of interest with the company. 85 A summary of the risk-of-bias assessment of the case series studies is presented in Figure 7 and the results of individual study level assessments are provided in Appendix 13.…”

Section: Case Series Studiesmentioning

confidence: 99%

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Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Brazzelli

Cruickshank

Tassie

et al. 2015

Health Technol Assess

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BackgroundDupuytren’s disease is a slowly progressive condition of the hand, characterised by the formation of nodules in the palm that gradually develop into fibrotic cords. Contracture of the cords produces deformities of the fingers. Surgery is recommended for moderate and severe contractures, but complications and/or recurrences are frequent. Collagenase clostridium histolyticum (CCH) has been developed as a minimally invasive alternative to surgery for some patients.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of collagenase as an alternative to surgery for adults with Dupuytren’s contracture with a palpable cord.Data sourcesWe searched all major electronic databases from 1990 to February 2014.Review methodsRandomised controlled trials (RCTs), non-randomised comparative studies and observational studies involving collagenase and/or surgical interventions were considered. Two reviewers independently extracted data and assessed risk of bias of included studies. A de novo Markov model was developed to assess cost-effectiveness of collagenase, percutaneous needle fasciotomy (PNF) and limited fasciectomy (LF). Results were reported as incremental cost per quality-adjusted life-year (QALY) gained. Deterministic and probabilistic sensitivity analyses were undertaken to investigate model and parameter uncertainty.ResultsFive RCTs comparing collagenase with placebo (493 participants), three RCTs comparing surgical techniques (334 participants), two non-randomised studies comparing collagenase and surgery (105 participants), five non-randomised comparative studies assessing various surgical procedures (3571 participants) and 15 collagenase case series (3154 participants) were included. Meta-analyses of RCTs assessing CCH versus placebo were performed. Joints randomised to collagenase were more likely to achieve clinical success. Collagenase-treated participants experienced significant reduction in contracture and an increased range of motion compared with placebo-treated participants. Participants treated with collagenase also experienced significantly more adverse events, most of which were mild or moderate. Four serious adverse events were observed in the collagenase group: two tendon ruptures, one pulley rupture and one complex regional pain syndrome. Two tendon ruptures were also reported in two collagenase case series. Non-randomised studies comparing collagenase with surgery produced variable results and were at high risk of bias. Serious adverse events across surgery studies were low. Recurrence rates ranged from 0% (at 90 days) to 100% (at 8 years) for collagenase and from 0% (at 2.7 years for fasciectomy) to 85% (at 5 years for PNF) for surgery. The results of the de novo economic analysis show that PNF was the cheapest treatment option, whereas LF generated the greatest QALY gains. Collagenase was more costly and generated fewer QALYs compared with LF. LF was £1199 more costly and generated an additional 0.11 QALYs in comparison with PNF. The incremental cost-effectiveness ratio was £10,871 per QALY gained. Two subgroup analyses were conducted for a population of patients with moderate and severe disease and up to two joints affected. In both subgroup analyses, collagenase remained dominated.LimitationsThe main limitation of the review was the lack of head-to-head RCTs comparing collagenase with surgery and the limited evidence base for estimating the effects of specific surgical procedures (fasciectomy and PNF). Substantial differences across studies further limited the comparability of available evidence. The economic model was derived from a naive indirect comparison and was hindered by a lack of suitable data. In addition, there was considerable uncertainty about the appropriateness of many assumptions and parameters used in the model.ConclusionsCollagenase was significantly better than placebo. There was no evidence that collagenase was clinically better or worse than surgical treatments. LF was the most cost-effective choice to treat moderate to severe contractures, whereas collagenase was not. However, the results of the cost–utility analysis are based on a naive indirect comparison of clinical effectiveness, and a RCT is required to confirm or refute these findings.Study registrationThis study is registered as PROSPERO CRD42013006248.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: Case Series Studiesmentioning

confidence: 99%

Section: Case Series Studiesmentioning

confidence: 99%

Section: Case Series Studiesmentioning

confidence: 99%

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Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Brazzelli

Cruickshank

Tassie

et al. 2015

Health Technol Assess

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Cost-effectiveness of Recurrent Dupuytren Contracture Treatment

et al. 2020

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IMPORTANCE Owing to its tendency to recur, Dupuytren contracture often requires multiple treatments, which places additional economic burden on health care. The likelihood of contracture recurrence varies not only with treatment but also with disease characteristics, such as contracture severity and location, but prior cost-effectiveness analyses of Dupuytren contracture treatments have not considered these patient-specific disease characteristics. OBJECTIVE To identify the most cost-effective treatment regimen for patients with recurrent Dupuytren contracture. DESIGN, SETTING, AND PARTICIPANTS This economic evaluation was conducted with statetransition microsimulation modeling using data from published studies and Medicare. A simulated cohort of 10 000 individuals with Dupuytren contracture was created. Patients could transition yearly between the following health states: symptom-free, symptomatic, and death. Available treatments were collagenase clostridium histolyticum injection, percutaneous needle aponeurotomy (PNA), and limited fasciectomy (LF); individuals randomly chose any treatment when symptomatic. Patients were limited to 3 rounds of treatment for a contracture affecting 1 joint, totaling 27 unique combinations. If the contracture recurred after 3 treatments, patients lived with the disease for the remainder of life.

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Dupuytren disease

Werker

2015

Plastic and Reconstructive Surgery

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Efficacy and Safety of Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture: Short-Term Results From 2 Open-Label Studies

Cited by 122 publications

References 25 publications

Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Cost-effectiveness of Recurrent Dupuytren Contracture Treatment

Dupuytren disease

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