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A feasibility study for a randomised controlled trial of treatment withdrawal in psoriatic arthritis (REmoval of treatment for patients in REmission in psoriatic ArThritis (RETREAT (F))

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Abstract

TNF therapy is effective for all aspects of psoriatic disease, but these drugs are costly and the long-term effects are unknown. Further, methotrexate causes concern with long-term adverse events. The purpose of this pilot study was to test the feasibility of drug withdrawal from patients with psoriatic arthritis, in stable low disease state. We examined the availability of patients, their willingness to participate, study procedures, and the proportion of patients in the withdrawal arm who relapsed during the study. Low disease state was defined by minimal disease activity criteria (MDA), and relapse by failure to achieve these criteria. Patients in the withdrawal group underwent a phased withdrawal of medication where the last treatment added was the first withdrawn. Assessments were monthly for 3 months before study exit. Seventy-two patients were invited to participate, of which 57 were found to be eligible. Twenty-six (36.1 %) subsequently attended the screening visit but 9 failed eligibility criteria so that 17 patients (29.8 % of the 57 eligible patients, 95 % confidence interval (CI) 18.4, 43.4 %) were randomised at a ratio of 2:1 in favour of the withdrawal arm (11 withdrawals, 6 standard care). Six patients experienced a flare, all of whom were in the withdrawal arm (relapse rate 54.6 %, 95 % CI 23.4, 83.3 %). Four of the flares were apparent from visit 3 (8 weeks after starting withdrawal). Given the high relapse rate, an alternative trial design of partial treatment withdrawal, possibly including a patient preference arm, is recommended.

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Acknowledgments

The study was conceived by PSH, ARM and LCC. All authors contributed to trial design and all authors approved the final manuscript. The authors would like to thank members of the Trial Steering Committee and Data Monitoring Committee (Paresh Jobanputra, Zunaid Karim, Jon Packham, Martyn Lewis and Andrew Parkinson, the latter also serving on the Trial Management Committee). The study was funded by Arthritis Research UK.

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Authors and Affiliations

  1. York Teaching Hospitals NHS Trust, York, North Yorkshire, UK

    Anna Moverley

  2. University of Leeds, Leeds, UK

    Laura Coates, Helena Marzo-Ortega & Robin Waxman

  3. York Trials Unit, University of York, Heslington, York, UK

    David Torgerson, Kim Cocks & Judith Watson

  4. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK

    Philip S. Helliwell

Authors
  1. Anna Moverley
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  2. Laura Coates
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  3. Helena Marzo-Ortega
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  4. Robin Waxman
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  5. David Torgerson
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  6. Kim Cocks
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  7. Judith Watson
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  8. Philip S. Helliwell
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Correspondence to Philip S. Helliwell.

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Moverley, A., Coates, L., Marzo-Ortega, H. et al. A feasibility study for a randomised controlled trial of treatment withdrawal in psoriatic arthritis (REmoval of treatment for patients in REmission in psoriatic ArThritis (RETREAT (F)). Clin Rheumatol 34, 1407–1412 (2015). https://doi.org/10.1007/s10067-015-2886-1

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  • DOI: https://doi.org/10.1007/s10067-015-2886-1

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