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Randomized Controlled Trial
. 2020 Jan 15;21(1):90.
doi: 10.1186/s13063-019-4000-5.

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

Celia A J Michielsens  1   2 , Nadine Boers  3 , Nathan den Broeder  3 , Mark H Wenink  3 , Aatke van der Maas  3 , Elien A M Mahler  3 , Michelle L M Mulder  3   4 , Désirée van der Heijde  5 , Frank H J van den Hoogen  3   4 , Lise M Verhoef  3 , Alfons A den Broeder  3   4
Affiliations
Randomized Controlled Trial

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

Celia A J Michielsens et al. Trials. .

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).

Keywords: Dose reduction; Psoriatic arthritis; Randomised controlled trial; Spondyloarthritis; TNF inhibitors; Tapering.

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Conflict of interest statement

DvdH has received the following consulting fees: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma, Director of Imaging Rheumatology bv. AdB has received congress invitations from Roche, Cellgene, Pfizer, Abbvie, Biogen, and expert witness fees from Boehringer, BMS, Amgen, Feseniu, Novartis. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Standard protocol items: recommendation for interventional trials (SPIRIT) figure: trial visits and assessments. *Schedule of enrolment, time point in months. Patients visit the outpatient clinic every 3 months and if necessary extra visits are warranted. TNFi, tumour necrosis factor inhibitor
See this image and copyright information in PMC

References

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