TY - JOUR
T1 - Dosage reduction and discontinuation of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
T2 - Protocol for a pragmatic, randomised controlled trial (the BIOlogical Dose OPTimisation (BIODOPT) trial)
AU - Uhrenholt, Line
AU - Schlemmer, Annette
AU - Hauge, Ellen Margrethe
AU - Christensen, Robin
AU - Dreyer, Lene
AU - Suarez-Almazor, Maria E.
AU - Kristensen, Salome
N1 - Funding Information:
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).
Publisher Copyright:
© 2019 Author(s).
PY - 2019/7/1
Y1 - 2019/7/1
N2 - 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.
AB - 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.
KW - axial spondyloarthritis
KW - biological therapy
KW - dosage reduction
KW - psoriatic arthritis
KW - rheumatoid arthritis
KW - tapering
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U2 - 10.1136/bmjopen-2018-028517
DO - 10.1136/bmjopen-2018-028517
M3 - Article
C2 - 31292181
AN - SCOPUS:85068830017
SN - 2044-6055
VL - 9
JO - BMJ open
JF - BMJ open
IS - 7
M1 - e028517
ER -