Trial reportEBioMedicine2018
Anti-Tumour Necrosis Factor Therapy for Dupuytren's Disease: A Randomised Dose Response Proof of Concept Phase 2a Clinical Trial.
Trial report in EBioMedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03180957 (A Multi-centre, Double Blind, Randomised, Placebo-controlled, Parallel Group, Phase II Trial to Determine the Efficacy of Intra-nodular Injection of Anti-TNF to Control Disease Progression in Early Dupuytren's Disease, With a Dose Response.), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-centre, Double Blind, Randomised, Placebo-controlled, Parallel Group, Phase II Trial to Determine the Efficacy of Intra-nodular Injection of Anti-TNF to Control Disease Progression in Early Dupuytren's Disease, With a Dose Response.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- Fibroproliferative disorders and diabetes: Understanding the pathophysiologic relationship between Peyronie's disease, Dupuytren disease and diabetes.Endocrinology, diabetes & metabolism · 2021Pooled it
- Imaging for Dupuytren disease: a systematic review of the literature.BMC musculoskeletal disorders · 2019Pooled it
- Trial
- Biosimilars: A Virtuous Cycle of Sustainability and Innovation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Active synthesis of type I collagen homotrimer in Dupuytren's fibrosis is unaffected by anti-TNF-α treatment.JCI insight · 2025Article
- Challenges and innovations in the surgical treatment of advanced Dupuytren disease by percutaneous needle fasciotomy: indications, limitations, and medico-legal implications.Journal of orthopaedic surgery and research · 2024Article
- Pharmacotherapies in Dupuytren Disease: Current and Novel Strategies.The Journal of hand surgery · 2023Review
- Treatments for early-stage Dupuytren's disease: an evidence-based approach.The Journal of hand surgery, European volume · 2023Review
- Cost-effectiveness of adalimumab for early-stage Dupuytren's disease : an economic evaluation based on a randomized controlled trial and individual-patient simulation model.Bone & joint open · 2022Article
- Anti-tumour necrosis factor therapy for early-stage Dupuytren's disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial.The Lancet. Rheumatology · 2022Article
- The possible role of hypoxia in the affected tissue of relapsed clubfoot.Scientific reports · 2022Article
- Echogenicity of Dupuytren's nodules is correlated to myofibroblast load and nodule hardness.The Journal of hand surgery, European volume · 2022Article
- Treatment Options for Dupuytren's Disease: Tips and Tricks.Plastic and reconstructive surgery. Global open · 2022Review
- Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial.NIHR open research · 2022Article
- An Evaluation of the Source and Content of Dupuytren's Disease Information Available on the Internet.Cureus · 2021Article
- Identification of TNFR2 and IL-33 as therapeutic targets in localized fibrosis.Science advances · 2019Article
- Could coenzyme Q10 be the treatment for Dupuytren's disease?BMJ case reports · 2019Article
- Recent advances in the understanding of Dupuytren's disease.F1000Research · 2019Review
- Cytokine Targeted Therapy for Dupuytren's Disease.EBioMedicine · 2018Review
- 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).Wellcome open research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDupuytren's disease is a common fibrotic condition of the hand that causes irreversible flexion contractures of the fingers, with no approved therapy for early stage disease. Our previous analysis of surgically-excised tissue defined tumour necrosis factor (TNF) as a potential therapeutic target. Here we assessed the efficacy of injecting nodules of Dupuytren's disease with a TNF inhibitor.
methodsPatients were randomised to receive adalimumab on one occasion in dose cohorts of 15 mg in 0.3 ml, 35 mg in 0.7 ml, or 40 mg in 0.4 ml, or an equivalent volume of placebo in a 3:1 ratio. Two weeks later the injected tissue was surgically excised and analysed. The primary outcome measure was levels of mRNA expression for α-smooth muscle actin (ACTA2). Secondary outcomes included levels of α-SMA and collagen proteins. The trial was registered with ClinicalTrial.gov (NCT03180957) and the EudraCT (2015-001780-40).
findingsWe recruited 28 patients, 8 assigned to the 15 mg, 12 to the 35 mg and 8 to the 40 mg adalimumab cohorts. There was no change in mRNA levels for ACTA2, COL1A1, COL3A1 and CDH11. Levels of α-SMA protein expression in patients treated with 40 mg adalimumab (1.09 ± 0.09 ng per μg of total protein) were significantly lower (p = 0.006) compared to placebo treated patients (1.51 ± 0.09 ng/μg). The levels of procollagen type I protein expression were also significantly lower (p < 0.019) in the sub group treated with 40 mg adalimumab (474 ± 84 pg/μg total protein) compared with placebo (817 ± 78 pg/μg). There were two serious adverse events, both considered unrelated to the study drug.
interpretationIn this dose-ranging study, injection of 40 mg of adalimumab in 0.4 ml resulted in down regulation of the myofibroblast phenotype as evidenced by reduction in expression of α-SMA and type I procollagen proteins at 2 weeks. These data form the basis of an ongoing phase 2b clinical trial assessing the efficacy of intranodular injection of 40 mg adalimumab in 0.4 ml compared to an equivalent volume of placebo in patients with early stage Dupuytren's disease.
fundingHealth Innovation Challenge Fund (Wellcome Trust and Department of Health) and 180 Therapeutics LP.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.