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  • Long-term outcomes after disease activity-guided dose reduction of TNF inhibition in rheumatoid arthritis: 3-year data of the DRESS study - a randomised controlled pragmatic non-inferiority strategy trial

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Clinical and epidemiological research
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Long-term outcomes after disease activity-guided dose reduction of TNF inhibition in rheumatoid arthritis: 3-year data of the DRESS study - a randomised controlled pragmatic non-inferiority strategy trial
  1. Chantal AM Bouman1,
  2. Noortje van Herwaarden1,
  3. Frank HJ van den Hoogen1,2,
  4. Jaap Fransen2,
  5. Ronald F van Vollenhoven3,4,
  6. Johannes WJ Bijlsma5,
  7. Aatke van der Maas1,
  8. Alfons A den Broeder1,2
  1. 1Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands
  2. 2Department of Rheumatology, Radboud University Medical Centre, Nijmegen, The Netherlands
  3. 3Department of Clinical Immunology and Rheumatology, Academic Medical Center, Amsterdam, The Netherlands
  4. 4Department of Rheumatology, VU University Medical Centre, Amsterdam, The Netherlands
  5. 5Department of Rheumatology & Clinical Immunology, Utrecht University Medical Centre, Utrecht, The Netherlands
  1. Correspondence to Chantal AM Bouman, Department of Rheumatology, Sint Maartenskliniek, PO box 9011, Nijmegen 6500 GM, The Netherlands; C.Bouman{at}maartenskliniek.nl

Abstract

Objective Tumour necrosis factor inhibitors (TNFi) are effective in rheumatoid arthritis (RA), but disadvantages include adverse events (AEs) and high costs. This can be improved by disease activity-guided dose reduction (DR). We aimed to assess long-term outcomes of TNFi DR in RA by using 3-year data from the DRESS study (Dose REduction Strategy of Subcutaneous TNF inhibitors study).

Methods In the intervention phase (month 0–18) of the DRESS study (Dutch trial register, NTR 3216), patients were randomised to DR or usual care (UC). In the extension phase (month 18–36), treatment strategies in both groups converged to continuation of protocolised tight control and allowed dose optimisation. Intention-to-treat analyses were done on flare, disease activity (28 joint count-based disease activity score with C reactive protein (DAS28-CRP)), functioning (health assessment questionnaire-disability index (HAQ-DI)), quality of life (Euroqol 5 dimensions 5 levels questionnaire (EQ5D–5L)), medication use, radiographic progression (Sharp van der Heijde score (SvdH)) and AE.

Results 172/180 patients included in the DRESS study were included in the extension phase. Cumulative incidences of major flare were 10% and 12% (−2%, 95% CI −8 to 15) in DR and UC groups in the extension phase, and 17% and 14% (3%, 95% CI −9 to 13) from 0 to 36 months. Cumulative incidences of short-lived flares were 43% (33 to 52%)%) and 35% (23 to 49%)%) in DR and UC groups in the extension phase, and 83% (75 to 90%)%) and 44% (31 to 58%)%) from 0 to 36 months. Mean DAS28-CRP, HAQ-DI, EQ5D-5L and SvdH remained stable and not significantly different between groups. TNFi use remained low in the DR group and decreased in the UC group. Cumulative incidences of AE were not significantly different between groups.

Conclusions Safety and efficacy of disease activity guided TNFi DR in RA are maintained up to 3 years, with a large reduction in TNFi use, but no other benefits. Implementation of DR would vastly improve the cost-effective use of TNFi.

  • rheumatoid arthritis
  • TNF inhibitor
  • treatment optimization
  • flare

https://doi.org/10.1136/annrheumdis-2017-211169

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    Footnotes

    • Contributors CAMB, NvH, FHJvdH, JF, RFvV, HB, AvdM and AAdB were involved in the study design. CAMB, NvH, AvdM, FHJvdH and AAdB were involved in the data collection. CAMB, NvH, JF, AvdM and AAdB performed the data analyses. All authors were involved in writing and revision of the manuscript. CAMB declares she had full access to all the data in this study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    • Competing interests HB received grants and personal fees from Pfizer and AbbVie during the conduct of the study; grants and personal fees from Roche, BMS, MSD, UCB, all outside the submitted work. RFvV received grants from AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB and personal fees from AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Vertex, outside the submitted work. JF received a research grant from BMS. AAdB received congress invitations from Roche and Abvie and an expert witness fee from Amgen. The other authors declare that they have no conflicts of interest.

    • Ethics approval CMO region Arnhem Nijmegen.

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

    • Data sharing statement The authors commit to making the relevant anonymized patient level data available on reasonable request.