Dupuytren disease (DD), a common, fibroproliferative condition of the hand that can cause contracture of the fingers, currently has no approved treatment for its early stages, and surgical intervention is often required as the disease progresses.
Dupuytren disease (DD), a common, fibroproliferative condition of the hand that can cause contracture of the fingers, currently has no approved treatment for its early stages, and surgical intervention is often required as the disease progresses. However, injection with adalimumab has shown promise in this disease state, and a new trial aims to assess the health economics of targeting patients with early DD using adalimumab versus placebo.1
Earlier research has demonstrated that the pro-inflammatory cytokine tumor necrosis factor (TNF) is likely to have a prominent role in the progression of DD; TNF acts to promote contraction and profibrotic signaling in DD cells, and in vitro studies have shown that neutralizing antibodies to TNF downregulates microfibroblast activity.
In a phase 2 trial reported in 20182, patients with DD received injections of adalimumab before scheduled DD surgery to test the efficacy of different doses. Surgically excised tissue was then analyzed. The authors found that TNF inhibition decreased protein expression of procollagen type I, though it did not reduce nodule size or hardness after the single injection.
The new trial that includes an economic evaluation will enroll at least 138 patients with DD at centers in the United Kingdom and the Netherlands. The participants will receive either adalimumab or placebo (saline injection), and the researchers will seek to determine if the optimal dose of 40 mg of adalimumab is superior to placebo in controlling disease progression at 12 months.
This trial, say the investigators, is the first time that a randomized controlled trial has taken place with an economic evaluation among patients with DD. The key strengths of undertaking both tasks together, they say, include reliable estimates of cost effectiveness for later use in the National Health Service (NHS).
If adalimumab is determined to be cost-effective in treating DD, biosimilars may play a role in that outcome; biosimilar adalimumab first became available in Europe in October 2018, and the United Kingdom’s NHS has aggressively adopted biosimilars as a way to curb its spending on the brand-name adalimumab while preserving patient access to treatment.
In November 2018, the NHS announced that its negotiations for the best-value adalimumab had resulted in a plan that awarded lots to multiple biosimilar developers and that is poised to cut spending on adalimumab by 75%. Those savings, said the NHS, would be put back into health system.
1. Png ME, Dritsaki M, Gray A, Pinedo-Villanueva R, Rivero-Arias O, Nanchahal J. Economic evaluation plan of a randomised controlled trial of intra-nodular injection of anti-TNF and placebo among patients with early Dupuytren’s disease: Repurposing Anti-TNF for Treating Dupuytren’s Disease (RIDD) [published online February 12, 2019]. Wellcome Open Res. ncbi.nlm.nih.gov/pmc/articles/PMC6354323/.
2. Satish L. Cytokine targeted therapy for Dupuytren’s disease. EBioMedicine. 2018;34:14-15. ncbi.nlm.nih.gov/pmc/articles/PMC6116413/.