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  • Treat-to-target dose reduction and withdrawal strategy of TNF inhibitors in psoriatic arthritis and axial spondyloarthritis: a randomised controlled non-inferiority trial

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Psoriatic arthritis
Treat-to-target dose reduction and withdrawal strategy of TNF inhibitors in psoriatic arthritis and axial spondyloarthritis: a randomised controlled non-inferiority trial
  1. Celia AJ Michielsens1,2,
  2. Nathan den Broeder1,2,
  3. Frank HJ van den Hoogen1,
  4. Elien AM Mahler1,
  5. Steven Teerenstra3,
  6. Désirée van der Heijde4,
  7. Lise M Verhoef1,
  8. Alfons A den Broeder1,2
  1. 1 Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands
  2. 2 Department of Rheumatic Diseases, Radboudumc Radboud Institute for Health Sciences, Nijmegen, Gelderland, The Netherlands
  3. 3 Radboud Institute for Health Sciences, Department for Health Evidence, group Biostatistics, Radboudumc, Nijmegen, Gelderland, The Netherlands
  4. 4 Rheumatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
  1. Correspondence to Celia AJ Michielsens, Rheumatology, Sint Maartenskliniek, 6500 GM Nijmegen, Gelderland, The Netherlands; celiamichielsens{at}gmail.com

Abstract

Objectives Tumour necrosis factor inhibitors (TNFi) are effective in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), but are associated with a small (0.6%) increase in serious infection risk, patient burden due to need for self-injection and high costs. Treat-to-target (T2T) tapering might ameliorate these drawbacks, but high-quality evidence on T2T tapering strategies is lacking in PsA and axSpA.

Methods We performed a pragmatic open-label, monocentre, randomised controlled non-inferiority (NI) trial on T2T tapering of TNFi. Patients with PsA and axSpA using a TNFi with ≥6 months stable low disease activity (LDA) were included. Patients were randomised 2:1 to disease activity-guided T2T with or without tapering until withdrawal and followed-up to 12 months. Primary endpoint was the difference in proportion of patients having LDA at 12 months between groups, compared with a prespecified NI margin of 20%, estimated using a Bayesian prior.

Results 122 patients (64 PsA and 58 axSpA) were randomised to a T2T strategy with (N=81) or without tapering (N=41). The proportion of patients in LDA at 12 months was 69% for the tapering and 73% for the no-tapering group: adjusted difference 5% (Bayesian 95% credible interval: −10% to 19%) which confirms NI considering the NI margin of 20%. The mean percentage of daily defined dose was 53% for the tapering and 91% for the no-tapering group at month 12.

Conclusions A T2T TNFi strategy with tapering attempt is non-inferior to a T2T strategy without tapering with regard to the proportion of patients still in LDA at 12 months, and results in a substantial reduction of TNFi use.

Trial registration number NL 6771.

  • Spondylitis, Ankylosing
  • Arthritis, Psoriatic
  • Tumor Necrosis Factor Inhibitors

Data availability statement

Data are available upon reasonable request. The data underlying this article will be shared on reasonable request to the corresponding author.

https://doi.org/10.1136/annrheumdis-2022-222260

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    Data availability statement

    Data are available upon reasonable request. The data underlying this article will be shared on reasonable request to the corresponding author.

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    Footnotes

    • Handling editor Josef S Smolen

    • Contributors CM, NdB, FHJvdH, EAMM, ST, DvdH, LMV and AAdB contributed to study design. CM was responsible for data collection. CM, NdB and ST contributed to data analyses. All authors contributed to data interpretation and writing of the report. CM accepts full responsibility for the work and the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding This study received funding from ReumaNederland, a health fund covering different topics on rheumatism, the Netherlands.

    • Competing interests DvdH has received consulting fees from AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer and UCB Pharma and is director of Imaging Rheumatology. AAdB has received research grants (to the institution) from AbbVie, Lilly, Novartis, Sanofi, Galapagos and Gilead. The remaining authors have declared no conflicts of interest.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.