Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study

Ines Rombach, Laura Tucker, William Tillett, Deepak Jadon, Marion Watson, Anne Francis, Yvonne Sinomati, Susan J Dutton, Laura C Coates

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Abstract

Introduction: In psoriatic arthritis (PsA), treatment recommendations support first-line use of disease-modifying antirheumatic drugs (DMARDs). There are few treatment strategy trials, and no previous studies have investigated tailored treatment choice by disease severity. Studies in oligoarthritis (<5 inflamed joints) are limited but have suggested that some can be managed without DMARDs, preventing unnecessary side effects. This study aimed to assess the feasibility and acceptability of a study comparing standard DMARD treatment against symptomatic therapy in patients with mild psoriatic oligoarthritis. Methods: This trial was embedded within the MONITOR-PsA cohort, which uses a Trials Within Cohorts (TWiCs) design. Patients with newly diagnosed psoriatic oligoarthritis, with low disease activity (PASDAS ⩽ 3.2) and the absence of poor prognostic factors [C reactive protein (CRP) < 5 mg/dL, HAQ < 1, no radiographic erosions] were randomised open-label to either standard care with ‘step-up’ DMARD therapy or to symptomatic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and local corticosteroid injections to inflamed joints. Key outcomes were the proportion of eligible cohort patients, consent and study completion rate. Results: Over the 15-month study period, only one eligible patient was randomised. Although oligoarthritis patients represented 45% of patients in this early PsA cohort, the majority did not have mild disease (24% raised CRP, 51% moderate disease activity, 13% radiographic damage and/or poor function). Of those meeting trial inclusion criteria, many patients refused treatment in the observational cohort prior to an invitation into the trial as they did not wish to be treated with DMARDs. Conclusion: The study was not feasible as designed. Oligoarthritis represents around half of initial PsA presentations, but the majority starting therapy have high-impact disease. A small proportion have mild oligoarticular disease but many are not keen on treatment with DMARDs, given the potential side effects of these medications. Further research is needed to support evidence-based treatment in this subgroup. Trial registration number: – ClinicalTrials.gov (NCT03797872) and EudraCT (2018-001085-42).

Original languageEnglish
JournalTherapeutic Advances in Musculoskeletal Disease
Volume13
DOIs
Publication statusPublished - 10 Jan 2022

Bibliographical note

Funding Information:
The MONITOR-PsA team acknowledge the support and input from the Trial Steering Committee (Philip Helliwell, Chris Holroyd, Gareth Jones, Lucy McParland, John Swain, Alexandra Wright-Hughes) and the Data Safety and Monitoring Committee (Jon Packham, Sayam Dubash, Gayatri Mittal) who oversee the MONITOR cohort and embedded trials including POISE. This study has been conducted as part of the portfolio of trials in the registered UKCRC Oxford Clinical Trials Research Unit (OCTRU) at the University of Oxford. It has followed their Standard Operating Procedures ensuring compliance with the principles of Good Clinical Practice and the Declaration of Helsinki and any applicable regulatory requirements. We acknowledge the support of OCTRU staff: Lucy Eldridge and Patrick Julier. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the National Institute of Health Research (CS-2016-16-016) and supported by the NIHR Oxford Biomedical Research Centre. DJ acknowledges that this research was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215-42001) and Cambridge Arthritis Research Endeavour (CARE). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the National Institute of Health Research (CS-2016-16-016) and supported by the NIHR Oxford Biomedical Research Centre. DJ acknowledges that this research was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215-42001) and Cambridge Arthritis Research Endeavour (CARE). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Keywords

  • clinical trial
  • oligoarthritis
  • psoriatic arthritis

ASJC Scopus subject areas

  • Rheumatology
  • Orthopedics and Sports Medicine

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