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Abstract
Dupuytren's disease (DD) is a common fibroproliferative condition of the palmar and digital fascia of the hand; however, there is currently no approved treatment for early stage DD. The objective of this paper is to describe the methods applied to assess the cost-effectiveness of adalimumab injections compared to placebo for controlling the progression of early stage DD in the Repurposing Anti-TNF for Treating Dupuytren's Disease (RIDD) trial. Measure of effectiveness and resource use will be obtained from a randomised clinical trial, carried out in three healthcare centres, and recruiting a minimum of 138 patients aged 18 years and above with a diagnosis of early stage DD. Resource use and utility measures (quality-adjusted life years) will be collected at 3, 6, 9, 12 (primary outcome endpoint) and 18 months post-randomisation. A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs. The analysis will be performed from a health system (National Health Service and personal social services) perspective. Sensitivity analysis will be conducted to assess the robustness of the results. RIDD is the first randomised controlled trial with an economic evaluation conducted among patients with early stage DD. The protocol described here records our intent to conduct both a within-trial CUA alongside the RIDD study and a lifetime CUA using decision-analytic modelling.
Highlights
Dupuytren’s disease (DD) is a common and progressive fibroproliferative disorder of the palmar and digital fascia of the hand that affects 0.6% of the general population aged 18 years and 12% among those aged 55 years in Western countries[1].Current treatment for DD, which includes fasciectomy, needle fasciotomy and collagenase fasciotomy, aims to correct the flexion deformities and restore hand function and is recommended when the digital flexion contractures limit hand function and/or the proximal interphalangeal joint is flexed to 30 degrees or more
There were four studies, all of which included evidence from various sources, rather than a single randomised controlled trial, that reported the cost-effectiveness of collagenase clostridium histolyticum injection, percutaneous needle fasciotomy and limited fasciectomy among patients with late stage DD
The objectives of the economic evaluation conducted in this study are to assess the cost-effectiveness of anti-TNF compared to placebo among patients with early stage DD via a within-trial cost-utility analysis (CUA), and to model lifetime cost-utility if anti-TNF is shown to be effective in controlling disease progression at 12 months follow-up
Summary
Dupuytren’s disease (DD) is a common and progressive fibroproliferative disorder of the palmar and digital fascia of the hand that affects 0.6% of the general population aged 18 years and 12% among those aged 55 years in Western countries[1]. A detailed description of the study design is available in the published protocol which contains details on the methodology (e.g. recruitment, interventions, approval/consent, etc.)[4]. This trial has been registered with the European Clinical Trials Database (EudraCT: 2015-001780-40) and its Ethics Reference is 15/SC/0259. The primary objective of the second part of the trial is to determine if optimal dose of anti-TNF injection is superior to placebo injection in controlling disease progression among patients with early stage DD by assessment of nodule hardness at 12 months after the first treatment. Secondary objectives include comparing the development of Dupuytren’s nodules and its associated cord, flexion deformities of the fingers and impairment of hand function for participants between each treatment arms and monitoring for adverse events[4]
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