Abstract
BackgroundTumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). However, these drugs come with some disadvantages such as adverse events, practical burden for patients and high costs. Dose optimisation of TNFi after patients have reached low disease activity (LDA) has been shown feasible and safe in rheumatoid arthritis (RA). However, data on TNFi dose optimisation in PsA and axSpA are scarce, especially pragmatic, randomised strategy studies.MethodsWe developed an investigator-driven, pragmatic, open-label, randomised, controlled, non-inferiority trial (DRESS-PS) to compare the effects of a disease activity-guided treat-to-target strategy with or without a tapering attempt in patients with SpA (PsA and axSpA combined), ≥ 16 years of age, who are being treated with TNFi, and have had at least 6 months of low disease activity. The primary outcome is the percentage of patients in LDA after 12 months of follow up. Patients are assessed at baseline, 3, 6, 9, and 12 months of follow up. Bayesian power analyses with a weakened prior based on a similar study performed in RA resulted in a sample size of 95 patients in total.DiscussionMore knowledge on disease activity-guided treatment algorithms would contribute to better treatment choices and cost savings and potentially decrease the risk of side effects. In this article we elucidate some of our design choices on TNFi dose optimisation and its clinical and methodological consequences.Trial registrationDutch Trial Register, NL6771. Registered on 27 November 2018 (CMO NL66181.091.18, 23 October 2018).
Highlights
Tumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis
In addition to the motivations we provide for all the design choices we made in our study, we want to discuss some important overarching questions
We have decided to include patients with PsA and axial spondyloarthritis (axSpA) combined in one trial, as we argue that these disease entities are sufficiently similar and treated with similar TNFi to be analyzed in one composite group, making the study more feasible
Summary
Design The dose reduction strategy study of TNF inhibitors in psoriatic arthritis and axial spondyloarthritis patients (DRESS-PS) is a pragmatic, open-label, mono-centre, randomised, controlled, non-inferiority strategy trial, and is currently recruiting patients at the departments of Rheumatology of the Sint Maartenskliniek in Nijmegen and Woerden and at the department of Rheumatic Diseases of the Radboud University Medical Centre. (Radboudumc) in Nijmegen, the Netherlands (Fig. 1; Standard protocol items: recommendation for interventional trials (SPIRIT) checklist is shown in Additional file 1). The study design is inspired by the original DRESS study [19, 20]
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