{
  "abstract": "Objectives Previous work by an international taskforce delivered consensus to include rash, mucosal ulcers and alopecia in the mucocutaneous domain of a novel multi-domain clinical outcome measure for systemic lupus erythematosus (SLE) clinical trials, the Treatment Response Measure for SLE (TRM-SLE). (1) Here we report results of a consensus process to define a fit for purpose clinical outcome assessment and entry and response thresholds for assessment of mucocutaneous activity.Methods A multi-step consensus process was completed by a 18-person working group comprising rheumatologists, dermatologists, and patients with lived experience of mucocutaneous SLE. The domain scope for rash, mucosal ulcers and alopecia for the SLE clinical trial context was defined. Candidate outcome measures were nominated via an online survey. After structured discussion and review of results from the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) working group of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) addressing outcome measures for trials in cutaneous lupus (CLE), the working group selected a response measure and proceeded to nominal group technique (NGT) to reach consensus on thresholds defining entry and clinically meaningful minimum response.Results 100% consensus was achieved to define the scopes ( figure 1). Rash includes SLE-specific rashes such as acute cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus. Mucosal ulcers are limited to oral ulcers confirmed by assessor examination. Alopecia includes CLE-related alopecia and non-scarring alopecia, limited to the scalp. Potential measures of each domain were nominated, with CLASI featuring for all three. After discussion and review of the evidence, including outcomes from the Lupus ABC CLASI working group, there was unanimous agreement to adopt CLASI as the response measure for the mucocutaneous domain in TRM-SLE. Potential CLASI-A thresholds for entry and response were nominated, discussed and ranked via NGT, resulting in consensus on thresholds for entry (CLASI-A >=8) and minimum clinically meaningful response (CLASI-50: CLASI-A reduction by >50%) for use in TRM-SLE. Discussions will be held pending further evidence to define thresholds reflecting complete response.Abstract PO:05:141 Figure 1Conclusions CLASI, with meaningful thresholds for entry and improvement, will be adopted to classify treatment response of mucocutaneous SLE manifestations in 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": [
        "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",
        "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, Victoria, Australia, Melbourne, Australia"
      ],
      "name": "Darshini Ayton"
    },
    {
      "affiliations": [
        "Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, INDIA"
      ],
      "name": "Amita Aggarwal"
    },
    {
      "affiliations": [
        "Feinstein Lupus Center of Excellence, Feinstein Institutes for Medical Research, New York, USA"
      ],
      "name": "Cynthia Aranow"
    },
    {
      "affiliations": [
        "Department of Dermatology, University of Wisconsin School of Medicine and Public Health, Madison, USA"
      ],
      "name": "Lisa Arkin"
    },
    {
      "affiliations": [
        "Hope Arthritis Foundation, Nairobi, KENYA"
      ],
      "name": "Odette Cassidy"
    },
    {
      "affiliations": [
        "Sorbonne Université, Faculté de médecine, AP-HP, Service de Dermatologie et Allergologie, Hôpital Tenon, Paris, France"
      ],
      "name": "Francois Chasset"
    },
    {
      "affiliations": [
        "Department of Dermatology, University of Texas Southwestern Medical Centre, Dallas, USA"
      ],
      "name": "Benjamin F Chong"
    },
    {
      "affiliations": [
        "Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, USA"
      ],
      "name": "Scott A Elman"
    },
    {
      "affiliations": [
        "Lupus Foundation of America, Washington, D.C, USA"
      ],
      "name": "Toni Grimes"
    },
    {
      "affiliations": [
        "Amgen Inc., Thousand Oaks, USA"
      ],
      "name": "Elaine Karis"
    },
    {
      "affiliations": [
        "Department of Dermatology, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea"
      ],
      "name": "Hee Joo Kim"
    },
    {
      "affiliations": [
        "Department of Paediatrics and Child Health, Aga Khan University Medical College East Africa, Nairobi, Kenya"
      ],
      "name": "Angela Migowa"
    },
    {
      "affiliations": [
        "John Hopkins University School of Medicine, Baltimore, USA"
      ],
      "name": "Michelle Petri"
    },
    {
      "affiliations": [
        "Department of Dermatology, University of Rochester Medical Center, Rochester, USA"
      ],
      "name": "Christopher T Richardson"
    },
    {
      "affiliations": [
        "Lupus Foundation of America, Washington, D.C, USA"
      ],
      "name": "Stephanie Scoggins"
    },
    {
      "affiliations": [
        "Lupus Europe, Brussels, Belgium"
      ],
      "name": "Annemarie Sluijmers"
    },
    {
      "affiliations": [
        "AstraZeneca plc, Cambridge, UK"
      ],
      "name": "Sule Yavuz"
    },
    {
      "affiliations": [
        "Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, USA"
      ],
      "name": "Joseph F Merola"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hospital of the University of Pennsylvania, Philadelphia, USA"
      ],
      "name": "Victoria P Werth"
    }
  ],
  "title": "PO:05:141 Measurement of mucocutaneous domain activity in a novel treatment response measure for systemic lupus erythematosus clinical trials",
  "uid": "1a7de5b7-ce42-558a-936b-6fcf1bd5aab9"
}