scholarly journals Clinical outcome measures for cutaneous lupus erythematosus

Lupus ◽  
2010 ◽  
Vol 19 (9) ◽  
pp. 1137-1143 ◽  
Author(s):  
J. Albrecht ◽  
VP Werth
Keyword(s):  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Skin Diseases ◽  
Cutaneous Lupus Erythematosus ◽  
Severity Index ◽  
Controlled Clinical Trials ◽  
Global Response ◽  
Organ Specific ◽  
Cutaneous Lupus

Cutaneous lupus erythematosus (CLE) is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may have been partly due to a lack of suitable validated outcome instruments. Recently, the Food and Drug Administration (FDA) mandated that organ-specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient’s condition needs to be assessed in terms of quality of life, the patient’s global response, and organ-specific instruments that measure activity of the disease as well as damage due to the disease. For the skin, the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE. Lupus (2010) 19, 1137—1143.

scholarly journals Validation of the Cutaneous Lupus Erythematosus Disease Area and Severity Index and pSkindex27 for use in childhood-onset systemic lupus erythematosus

2018 ◽  
Vol 5 (1) ◽  
pp. e000275
Author(s):  
Ashwaq AlE'ed ◽  
Pinar Ozge Avar Aydin ◽  
Nora Al Mutairi ◽  
Alhanouf AlSaleem ◽  
Hafize Emine Sonmez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lupus Erythematosus ◽  
Cutaneous Lupus Erythematosus ◽  
Severity Index ◽  
Assessment Tools ◽  
Measurement Properties ◽  
Childhood Onset ◽  
Disease Area ◽  
Cutaneous Lupus

ObjectiveTo determine the measurement properties of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and the paediatric adaptation of the Skindex29 (pSkindex27) when used in childhood-onset SLE (cSLE).MethodsPatients with mucocutaneous involvement of cSLE were evaluated at the study entry and 6 months later. Besides the CLASI and pSkindex27, the Pediatric Quality of Life Inventory Generic Core scale (PedsQL-GC), its Rheumatology Module (PedsQL-RM), the SLE Disease Activity Index (SLEDAI) and the SLE Damage Index (SDI) were completed.ResultsThe CLASI and pSkindex27 had high internal consistency (both Cronbach α >0.82). Children were able to complete the pSkindex27, with self-report and caregiver proxy-reports showing excellent agreement (intraclass correlation coefficient=0.97). The CLASI Activity Score (CLASI-A) was strongly correlated with the mucocutaneous domain score of the SLEDAI as was the CLASI Damage Score (CLASI-D) with that of the SDI (both: Spearman correlation coefficients (rs) >0.68). pSkindex27 summary scores were moderately correlated with those of the PedsQL-GC and PedsQL-RM (all: rs>|0.51|), the CLASI-A and CLASI-D (both: rs> 0.64), respectively. Patients who experienced a >50% improvement of the CLASI-A between study visits had significantly higher PedsQL-GC and pSkindex27 scores than those without improvement of mucocutaneous features.ConclusionBoth CLASI and pSkindex27 are useful assessment tools in cSLE, active and chronic mucocutaneous lesions and their changes over time can be measured using the CLASI and the pSkindex27 can capture the impact of mucocutaneous involvement on patient health-related quality of life.

scholarly journals Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need

2021 ◽  
Vol 8 (1) ◽  
pp. e000529
Author(s):  
Lisa N Guo ◽  
Lourdes M Perez-Chada ◽  
Robert Borucki ◽  
Vinod E Nambudiri ◽  
Victoria P Werth ◽  
...  
Keyword(s):  
Disease Activity ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Core Outcome Set ◽  
Cutaneous Lupus Erythematosus ◽  
Core Outcome ◽  
Outcome Set ◽  
Starting Point ◽  
Cutaneous Lupus

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.

scholarly journals 424 Quality of life in patients with facial cutaneous lupus erythematosus

2020 ◽  
Vol 140 (7) ◽  
pp. S55
Author(s):  
J.S. Concha ◽  
D. Yan ◽  
A. Ravishankar ◽  
C. Bax ◽  
R. Borucki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lupus Erythematosus ◽  
Cutaneous Lupus Erythematosus ◽  
Cutaneous Lupus

scholarly journals Quality of Life Differences Between Responders and Nonresponders in the Treatment of Cutaneous Lupus Erythematosus

2013 ◽  
Vol 149 (1) ◽  
pp. 104 ◽  
Author(s):  
Aileen Y. Chang ◽  
Elizabeth Ghazi ◽  
Joyce Okawa ◽  
Victoria P. Werth
Keyword(s):  
Quality Of Life ◽  
Lupus Erythematosus ◽  
Cutaneous Lupus Erythematosus ◽  
Cutaneous Lupus

scholarly journals Quality of life in cutaneous lupus erythematosus

2011 ◽  
Vol 64 (5) ◽  
pp. 849-858 ◽  
Author(s):  
Rachel Klein ◽  
Siamak Moghadam-Kia ◽  
Lynne Taylor ◽  
Christopher Coley ◽  
Joyce Okawa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lupus Erythematosus ◽  
Cutaneous Lupus Erythematosus ◽  
Cutaneous Lupus

The study of Cutaneous Lupus Erythematosus Disease Area and Severity Index in Indian patients with systemic lupus erythematosus

Lupus ◽  
2011 ◽  
Vol 20 (14) ◽  
pp. 1510-1517 ◽  
Author(s):  
P Salphale ◽  
D Danda ◽  
L Chandrashekar ◽  
D Peter ◽  
N Jayaseeli ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Cutaneous Lupus Erythematosus ◽  
Severity Index ◽  
Skin Lesions ◽  
Systemic Lupus ◽  
Disease Area ◽  
Indian Patients ◽  
The Mean ◽  
Cutaneous Lupus

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a newly described tool used to assess the activity of and damage caused by cutaneous lupus erythematosus (CLE). There is a paucity of data on CLASI from the Indian subcontinent. We sought to determine the applicability of CLASI in specific lesions of CLE in patients with systemic lupus erythematosus (SLE) attending a tertiary care hospital in India. In this prospective, cross-sectional study, 93 patients of SLE with cutaneous lesions were recruited. CLASI activity and damage scores of lupus erythematosus (LE)-specific skin lesions were done in 75 patients with SLE. The mean CLASI activity score was 15.4 ± 9.4 (range 0–39) and the mean damage score was 6.87 ± 7.75 (range 0–30). Higher mean CLASI activity scores were seen in patients with a combination of acute, subacute and chronic CLE and in those with widespread lesions. Patients with longstanding disease and long duration of skin lesions had higher damage scores. This study shows that CLASI is an effective tool to assess cutaneous activity of LE-specific lesions, and the damage caused by them, in Indian patients.

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