ArticleJournal of the American Academy of Dermatology2021
Evaluating change in disease activity needed to reflect meaningful improvement in quality of life for clinical trials in cutaneous lupus erythematosus.
Article in Journal of the American Academy of Dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
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Who cites it
13 citing papers in PubMed, 29 citations in OpenAlex.
- Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Trial
- Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study.Rheumatology (Oxford, England) · 2022Trial
- Recommendations for the use of CLASI as an outcome measure in cutaneous lupus erythematosus clinical trials.Nature reviews. Rheumatology · 2026Review
- Erythema and scale in cutaneous lupus erythematosus significantly impacts patient quality of life and disease course impression.The British journal of dermatology · 2025Article
- Cutaneous lupus erythematosus: Expanding clinical trial eligibility criteria based on quality of life data.Journal of the American Academy of Dermatology · 2024Article
- 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
- Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective.Lupus science & medicine · 2023Article
- Comparative responsiveness of cutaneous lupus erythematosus patients to methotrexate and mycophenolate mofetil: A cohort study.Journal of the American Academy of Dermatology · 2022Article
- The Meaning and Reliability of Minimal Important Differences (MIDs) for Clinician-Reported Outcome Measures (ClinROMs) in Dermatology-A Scoping Review.Journal of personalized medicine · 2022Article
- Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need.Lupus science & medicine · 2021Review
- The CLASI, a validated tool for the evaluation of skin disease in lupus erythematosus: a narrative review.Annals of translational medicine · 2021Review
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundOutcome measures of clinical trials in cutaneous lupus erythematosus (CLE) should reflect clinically meaningful improvement in disease activity, as measured by the Cutaneous Lupus Disease Area and Severity Index activity score (CLASI-A).
objectiveWe aimed to define the degree of improvement in disease activity meaningful to a patient's quality of life.
methodsThe change in the CLASI-A in 126 patients needed to predict meaningful change in QoL, as defined by the Emotions and Symptoms subscales of the Skindex-29, was evaluated by linear regression models.
resultsIn patients with an initial CLASI-A of ≥8, a 42.1% or ≥7-point and a 31.0% or ≥5-point decrease in CLASI-A predicts meaningful improvement in the Emotions and the Symptoms subscales, respectively. LIMITATIONS: This is a retrospective study of prospectively collected data at a single site.
conclusionsA CLASI-A score of ≥8 for trial entry allows for inclusion of patients with milder disease where CLASI-A improvement by ≥50% is clinically significant and meaningful.
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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.