Expert consensus achieved on a working core outcome set for cutaneous lupus erythematosus research in survey following the 5th International Conference on Cutaneous Lupus Erythematosus (ICCLE)

Abstract

Cutaneous lupus erythematosus (CLE) is a potentially disfiguring and debilitating manifestation of lupus erythematosus, a heterogeneous autoimmune disease with a broad spectrum of organ system involvement and clinical presentations. Despite CLE’s demonstrated impact on patients’ quality of life, no drugs for treatment of CLE have been approved by the Food and Drug Administration. One proposed driver of this gap is a focus on SLE rather than its cutaneous counterpart in therapeutic development programmes. Another challenge is the lack of regulatory acceptance of and clarity on existing endpoints, which has inhibited some expansion into this area of the field. To address an urgent unmet need for guidance around a standardised outcome measurement set in CLE research, a steering committee comprised of dermatologists and rheumatologists proposed a working core outcome set (COS) for randomised controlled trials and longitudinal observational studies. A COS comprises outcomes that must be assessed and documented in every clinical trial related to a specific medical condition.1 This ensures uniformity in assessing and reporting outcomes across different clinical studies. Following the Outcome Measures In Rheumatology (OMERACT) Filter 2.1 Onion framework,2 the steering committee first classified candidate outcomes as ‘core domains’ (ie, relevant domains and subdomains that should be measured in every study for a given disease), ‘important but optional’ domains and ‘research agenda’ domains. Subsequently, they recommended candidate outcome measures for each core domain based on review of the literature (table 1).3 The proposed COS (ie, core domain set and corresponding outcome measurement set) represents a ‘working’ set to bridge an urgent need while allowing more rigorous methodological approaches to continue in …