Unknown

Dataset Information

0

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial.


ABSTRACT: BACKGROUND:Tumour 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. METHODS:We 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. DISCUSSION:More 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 REGISTRATION:Dutch Trial Register, NL6771. Registered on 27 November 2018 (CMO NL66181.091.18, 23 October 2018).

SUBMITTER: Michielsens CAJ 

PROVIDER: S-EPMC6964104 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

altmetric image

Publications

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial.

Michielsens Celia A J CAJ   Boers Nadine N   den Broeder Nathan N   Wenink Mark H MH   van der Maas Aatke A   Mahler Elien A M EAM   Mulder Michelle L M MLM   van der Heijde Désirée D   van den Hoogen Frank H J FHJ   Verhoef Lise M LM   den Broeder Alfons A AA  

Trials 20200115 1


<h4>Background</h4>Tumour 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 opt  ...[more]

Similar Datasets

| S-EPMC6323809 | biostudies-literature
| S-EPMC7675867 | biostudies-literature
| S-EPMC4390320 | biostudies-literature
| S-EPMC7368134 | biostudies-literature
| S-EPMC6624054 | biostudies-literature
| S-EPMC10796874 | biostudies-literature
| S-EPMC5696278 | biostudies-literature
| S-EPMC4016115 | biostudies-literature
| S-EPMC10129963 | biostudies-literature
| S-EPMC7733711 | biostudies-literature