Anti-tumour necrosis factor therapy for early-stage Dupuytren's disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial

Nanchahal, Jagdeep; Ball, Catherine; Rombach, Ines; Williams, Lynn M.; Kenealy, Nicola; Dakin, Helen; O’Connor, Heather; Davidson, Dominique; Werker, Paul M. N.; Dutton, Susan; Feldmann, Marc; Lamb, Sarah E

doi:10.1016/s2665-9913(22)00093-5

Cited by 16 publications

(24 citation statements)

References 32 publications

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“…Two UK centres recruited 140 participants between February 2017 and April 2019. 9 At 12 months, 128 (91%) participants had quality of life data and 130 (93%) had healthcare resource use (Supplementary Table ii). EQ-5D-5L utilities remained relatively constant during the trial, with a mean between-group difference of 0.011 (95% CI -0.026 to 0.048) at 12 months (linear mixed model, Supplementary At a 12-month time horizon, adalimumab cost £503,410 per QALY gained and the probability of adalimumab injections being cost-effective at a willingness to pay threshold of £20,000/QALY was < 1% (Table II, Supplementary Figure a).…”

Section: Resultsmentioning

confidence: 99%

“…For both the within-trial and model-based economic evaluation, the patient population comprised adults with progressive early-stage DD who met the RIDD inclusion criteria: active extensor deficit ≤ 30° and an established, clinically distinct nodule with a clear history of progression in the preceding six months. 9 Both analyses took an NHS and personal and social services (PSS) perspective, following the NICE reference case. 14 Following UK guidelines, 14 we conducted a cost-utility analysis, measuring health outcomes in quality-adjusted life years (QALYs).…”

Section: Methodsmentioning

confidence: 99%

“…This was varied between the trial duration (1.5 years) and 5 years (approximately 3 times the trial duration) in one-way and probabilistic sensitivity analyses. The RIDD trial observed that adalimumab-treated nodules continued to soften and reduce in size over the nine-month period between end of treatment and 18 months, 9 suggesting that the duration of quiescence is likely to be substantially longer than 1.5 years. Natural history studies have shown that many patients with untreated early-stage DD have periods of quiescence (during which the nodule is inactive and cords are unlikely to develop) and periods of activity (during which the nodule is more active and a cord may develop).…”

Section: Assumptionmentioning

confidence: 99%

“…Within RIDD, there was no relationship between the development of antibodies against adalimumab and response to treatment. 9 Patients who did not reach quiescence with initial treatment were assumed to receive no further treatment for early-stage DD.…”

Section: Assumptionmentioning

confidence: 99%

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Cost-effectiveness of adalimumab for early-stage Dupuytren’s disease

et al. 2022

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Aims To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective. Methods We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded. Results The within-trial economic evaluation found that adalimumab plus standard care cost £503,410 per quality-adjusted life year (QALY) gained versus standard care alone over a 12-month time horizon. The model-based extrapolation suggested that, over a lifetime, repeated courses of adalimumab could cost £14,593 (95% confidence interval £7,534 to £42,698) per QALY gained versus standard care alone. If the NHS was willing to pay £20,000/QALY gained, there is a 77% probability that adalimumab with retreatment is the best value for money. Conclusion Repeated courses of adalimumab are likely to be a cost-effective treatment for progressive early-stage DD. The value of perfect parameter information that would eliminate all uncertainty around the parameters estimated in RIDD and the duration of quiescence was estimated to be £105 per patient or £272 million for all 2,584,411 prevalent cases in the UK. Cite this article: Bone Jt Open 2022;3(11):898–906.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Assumptionmentioning

confidence: 99%

Section: Assumptionmentioning

confidence: 99%

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Cost-effectiveness of adalimumab for early-stage Dupuytren’s disease

et al. 2022

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“…This randomized trial from Oxford (UK) compared anti-TNF injections to placebo in the treatment of early Dupuytren’s disease. 1 All patients enrolled in the study had early Dupuytren’s with nodules present, but without progression to contractures. A total of 140 patients were randomized to either four adalimumab injections or four saline injections over the course of a year.…”

Section: Anti-tumour Necrosis Factor Therapy For Early-stage Dupuytre...mentioning

confidence: 99%

Wrist & Hand

2022

Bone & Joint 360

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The December 2022 Wrist & Hand Roundup360 looks at: Anti-tumour necrosis factor therapy for early-stage Dupuytren’s disease; Patient experiences of scaphoid waist fractures and their treatment; Postoperative complications following open a1 pulley release for a trigger finger or thumb; How certain are findings in distal radius fractures: a systematic review of randomized controlled trials; Partial wrist denervation in wrist osteoarthritis: patient-reported outcomes and objective function; Dorsal bridge plating versus bridging external fixation for management of complex distal radius fractures; How is reduction lost in distal radius fractures in females aged 50 years and older; The HAND-Q: psychometrics of a new patient-reported outcome measure for clinical and research applications.

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