ReviewLupus science & medicine2021
Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need.
Review in Lupus science & medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Placebo Response in Randomised Controlled Trials of Systemic Therapies for Cutaneous Lupus Erythematosus: A Systematic Review and Meta-Analysis.Pharmaceutical medicine · 2026Pooled it
- Recommendations for the use of CLASI as an outcome measure in cutaneous lupus erythematosus clinical trials.Nature reviews. Rheumatology · 2026Review
- What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond.The Journal of clinical and aesthetic dermatology · 2026Review
- Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Afimetoran, a Toll-Like Receptor 7 and 8 Inhibitor, in Patients With Cutaneous Lupus Erythematosus: A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study.ACR open rheumatology · 2025Article
- Subtype and Racial Erythema Variation for Cutaneous Lupus Trials.JAMA dermatology · 2025Article
- An update on clinical trials for cutaneous lupus erythematosus.The Journal of dermatology · 2024Review
- 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).Lupus science & medicine · 2024Article
- Clinical trial outcomes for SLE: what we have and what we need.Lupus science & medicine · 2024Review
- Editorial: Cutaneous lupus erythematosus landscape: pathophysiology, unmet needs, and related challenges in clinical practice. What is on the horizon?Frontiers in medicine · 2024Article
- Anifrolumab for Moderate and Severe Muco-Cutaneous Lupus Erythematosus: A Monocentric Experience and Review of the Current Literature.Biomedicines · 2023Article
- Cutaneous Involvement in Systemic Lupus Erythematosus: A Review for the Rheumatologist.The Journal of rheumatology · 2023Review
- Cutaneous lupus erythematosus disease assessment: Highlighting CLE outcome measures.Frontiers in medicine · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectiveThe lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies.
methodsWe conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined.
resultsProposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument.
conclusionThis work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.