{
  "abstract": "Objectives To define a fit-for-purpose clinical outcome assessment for lupus arthritis, with thresholds for entry and improvement, which will form part of the Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE), a novel multi-domain outcome measure for SLE clinical trials.Methods A multi-step consensus process was completed by an international working group comprising ten expert clinicians (including seven adult rheumatologists and three paediatric rheumatologists), one medical statistician and four SLE patients with lived experience of lupus arthritis. First, the domain scope for arthritis in the SLE clinical trial context was defined via structured discussion. Candidate response measures were then nominated via an online survey, and shortlisted for evaluation in a systematic literature review (SLR) focussing on relevant measurement properties and clinical trial utility. Informed by the SLR results, nominal group technique (NGT) was utilised to reach a consensus on a measure for the arthritis domain.Results The arthritis domain was defined with 100% consensus as ‘active inflammatory arthropathy attributed to lupus that impacts the patient and is modifiable by therapy to reduce or control disease activity’, and the scope defined as synovitis, tenosynovitis or other confirmed articular/periarticular inflammation attributed to lupus. Other arthropathies, joint damage and painful pathologies due to lupus that are not musculoskeletal in nature were listed as specific exclusions. A total of 47 measures were nominated for consideration to fit this scope, shortlisted via discussion to 8 (listed in figure 1) which proceeded to evaluation via SLR. The SLR screened 3,729 articles, of which 46 were included. Following review and discussion of the SLR results, 25 unique instruments (either individual measures or a combination of multiple measures) were nominated via survey, and ranked via NGT. The Lupus Arthritis and Musculoskeletal Disease Activity score (LAMDA) was the most highly ranked option. LAMDA incorporates swollen joint count, patient musculoskeletal pain visual analogue scale (VAS), physician musculoskeletal disease activity VAS and erythrocyte sedimentation rate (ESR).Abstract PO:05:137 Figure 1Conclusions Based on formal consensus methodology supported by an SLR, an expert panel including patients reached consensus to use LAMDA to measure disease activity for enrolment and treatment response in the arthritis domain of TRM-SLE.",
  "authors": [
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia",
        "Department of Rheumatology, Monash Health, Clayton, Australia"
      ],
      "name": "Kathryn Connelly"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia",
        "Department of Rheumatology, Monash Health, Clayton, Australia"
      ],
      "name": "Eric F Morand"
    },
    {
      "affiliations": [
        "Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK",
        "NIHR Leeds Biomedical Research Centre, Leeds, UK"
      ],
      "name": "Elizabeth MA Hensor"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia"
      ],
      "name": "Rachel Koelmeyer"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia",
        "Department of Rheumatology, Monash Health, Clayton, Australia"
      ],
      "name": "Lavanya Rajagopala"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia"
      ],
      "name": "John May"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia",
        "Department of Rheumatology, Monash Health, Clayton, Australia"
      ],
      "name": "Ambika Wakhlu"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia"
      ],
      "name": "Yanjie Hao"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash University, Clayton, Australia",
        "Department of Rheumatology, Monash Health, Clayton, Australia"
      ],
      "name": "Katie Liao"
    },
    {
      "affiliations": [
        "School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia"
      ],
      "name": "Darshini Ayton"
    },
    {
      "affiliations": [
        "Library, Monash Health, Clayton, Australia"
      ],
      "name": "Cassandra Gorton"
    },
    {
      "affiliations": [
        "Department of Orthopedics, Rheumatology and Traumatology, School of Medical Science, University of Campinas, Campinas, BRAZIL"
      ],
      "name": "Simone Appenzellar"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Columbia University Irving Medical Center, New York City, USA"
      ],
      "name": "Anca D Askanase"
    },
    {
      "affiliations": [
        "UMass Chan Medical School, Worcester, USA"
      ],
      "name": "Roberto Caricchio"
    },
    {
      "affiliations": [
        "Lupus Foundation of America, Washington D.C., USA"
      ],
      "name": "Khadija Dantata"
    },
    {
      "affiliations": [
        "N/A, N/A, * OTHER"
      ],
      "name": "Alan Friedman"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Sandra Garces"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Monash Health, Clayton, Australia",
        "School of Clinical Sciences, Monash University, Clayton, Australia"
      ],
      "name": "Alberta Hoi"
    },
    {
      "affiliations": [
        "Genentech, South San Francisco, USA"
      ],
      "name": "Justine Maller"
    },
    {
      "affiliations": [
        "Lupus Europe, Brussels, Belgium"
      ],
      "name": "Francesca Marchiori"
    },
    {
      "affiliations": [
        "Japan Connective Tissue Diseases Association (Lupus Japan), Tokyo, Japan"
      ],
      "name": "Shiori Nagamori"
    },
    {
      "affiliations": [
        "Lupus Europe, Brussels, Belgium"
      ],
      "name": "Blanca Rubio"
    },
    {
      "affiliations": [
        "Department of Women’s and Children’s Health, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK",
        "Department of Paediatric Rheumatology, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK"
      ],
      "name": "Eve MD Smith"
    },
    {
      "affiliations": [
        "Universidad Cientifica del Sur, Lima, Peru and Hospital Guillermo Almenara Irigoyen-EsSalud, Lima, Peru"
      ],
      "name": "Manuel F Ugarte-Gil"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Autoimmunity and Inflammation, University of California, San Diego, USA"
      ],
      "name": "Kenneth Kalunian"
    },
    {
      "affiliations": [
        "Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK",
        "NIHR Leeds Biomedical Research Centre, Leeds, UK"
      ],
      "name": "Edward M Vital"
    }
  ],
  "title": "PO:05:137 Measurement of arthritis in a novel treatment response measure for systemic lupus erythematosus clinical trials",
  "uid": "c7ebe702-1c14-50fa-ae93-a31de10bdc6a"
}