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Dosage reduction and discontinuation of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: protocol for a pragmatic, randomised controlled trial (the BIOlogical Dose OPTimisation (BIODOPT) trial)
  1. Line Uhrenholt1,2,
  2. Annette Schlemmer1,
  3. Ellen-Margrethe Hauge3,4,
  4. Robin Christensen2,5,
  5. Lene Dreyer1,6,
  6. Maria E Suarez-Almazor7,
  7. Salome Kristensen1
  1. 1Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark
  2. 2Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
  3. 3Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  4. 4Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  5. 5Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark
  6. 6Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
  7. 7Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  1. Correspondence to Salome Kristensen; sakr{at}rn.dk

Abstract

Introduction The The BIOlogical Dose OPTimisation (BIODOPT) trial is a pragmatic, multicentre, randomised controlled, open-label, parallel-group, equivalence study designed to evaluate tapering of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) in sustained clinical remission or low disease activity (LDA). Traditionally, these patients maintain standard dosage of bDMARD lifelong; however, recent studies indicate that a significant proportion of patients in sustained remission or LDA can taper their bDMARD and maintain stable disease activity. Thus, this trial aims to evaluate whether a disease activity-guided tapering strategy for bDMARDs will enable a significant dosage reduction while maintaining disease activity compared with usual care. From the individual patient’s standpoint as well as from a societal perspective, it would be advantageous if bDMARDs could be reduced or even discontinued while maintaining disease activity.

Methods and analysis A total of 180 patients with RA, PsA or axSpA treated with bDMARDs and in clinical remission/LDA during the past 12 months will be enrolled from four centres in Denmark. Patients will be randomised in a ratio of 2:1 to either disease activity-guided tapering of bDMARDs (intervention group) or continuation of bDMARDs as usual care (control group).

The primary objective is the difference between the two groups in the proportion of patients who have reduced their inclusion dosage of bDMARDs to 50% or less while maintaining stable disease activity at 18 months follow-up.

Ethics and dissemination The study is approved by the ethics committee of Northern Jutland, Denmark (N-20170073) and by the Danish Medicine Agency. Patient research partner KHH contributed to refinement of the protocol and approved the final manuscript. Results will be disseminated through publication in international peer-reviewed journals.

Trial registration number 2017-001970-41; Pre-results.

  • rheumatoid arthritis
  • psoriatic arthritis
  • axial spondyloarthritis
  • biological therapy
  • tapering
  • dosage reduction

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors LU, SK and AS conceived the trial hypothesis and LU, SK, AS, EMH and RC have designed the trial. SK is the trial sponsor-investigator and LU is the coordinating investigator. LU, SK, AS, EMH, RC and LD are responsible for implementation of the trial, analysis of the results and publication in scientific journals. LU, SK, AS, EMH and RC all contributed to refinement of the trial protocol and approved the final manuscript. LU wrote this protocol paper and SK, AS, LD, EMH, RC and MESA contributed with refinement and approved the final draft.

  • Funding This trial was initiated by the BIODOPT trial group; thus, no pharmaceutical companies or funding parties are involved in the design or conduct of the trial or analyses of the trial results. This work was supported by the Danish Regions (Regionernes Medicinpulje) grant number 16/2885, the Health Science Research Fund of the North Denmark Region grant number 2016-017615 and the Department of Rheumatology at Aalborg University Hospital. Musculoskeletal Statistics Unit at the Parker Institute is supported by a core grant from the Oak Foundation (OCAY-13-309).

  • Competing interests LU has received speaker honoraria from Abbvie, Eli Lilly and Novartis (not related to the submitted work). SK has received speaker honoraria from Novartis and Eli Lilly (not related to the submitted work). AS has received speaker honoraria from MSD and Eli Lilly (not related to the submitted work). LD has received speaker honoraria from UCB, MSD, Eli Lilly and Janssen Pharmaceutica (not related to the submitted work).

  • Ethics approval This trial is approved by the ethics committee of Northern Jutland, Denmark (N-20170073) and by the Danish Medicine Agency (2017091722) and the Danish Data Protection Agency (2017–194). The BIODOPT trial is conducted in accordance with the Helsinki Declaration.

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

  • Patient consent for publication Not required.

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