New Approach to Cutaneous Lupus Erythematosus Clinical Improvement Measurement May Help Better Understand Response to Treatment and Guide Future Trial Design
To improve cutaneous lupus erythematosus (CLE) clinical study design, investigators analyzed a range of Cutaneous Lupus Activity and Severity Index (CLASI) outcomes in a group of 140 people to identify meaningful changes in disease course that may have otherwise been missed.
The clinical manifestations, severity and course of CLE are highly variable, challenging the development of clear outcome measures to assess the effectiveness of different therapies and selection of most appropriate treatments. The CLASI scoring system is commonly used to help guide treatment – CLASI-A evaluates manifestations such as erythema, scaling and skin damage and CLASI-B evaluates other developments like dyspigmentation and scarring.
By examining a range of outcome definitions rather than focusing on a single threshold to classify treatment response, the researchers were able to identify demographic and clinical factors associated with likelihood of CLE improvement across different thresholds. Additionally, they found that less stringent thresholds may not reliably distinguish meaningful clinical improvement from expected changes in disease course, particularly for CLASI-A.
The investigators also identified association patterns that will aid providers in setting expectations when counseling people with CLE. The age of CLE development was associated with increased likelihood of disease activity improvement, and initial CLE activity was associated with lower likelihood of CLE damage improvement.
Defining how different CLASI improvement thresholds influence models of CLE improvement is critical to CLE clinical study design. This study can potentially help model future studies. Learn more about cutaneous lupus.