Using Statistical Methods to Modify and Repurpose the Composite Assessment of Index Lesion Severity Scoring System in Cutaneous Lichen Planus

• Activity Number: 385 - Biomarkers, Endpoint Validation and Other Topics
• Type: Contributed
• Date/Time: Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Nan Zhang* and Caitlin Brumfiel and Meera Patel and Amylou Dueck and Mark Pittelkow and Aaron Mangold
• Companies: Mayo Clinic and Mayo Clinic and Mayo Clinic and Mayo Clinic and Mayo Clinic and Mayo Clinic
• Keywords: mCAILS; optimize scoring system; clinical trial; repeated-measure data

Abstract

The Composite Assessment of Index Lesion Severity (CAILS) system is a validated lesional scoring assessment used in cutaneous T-cell lymphoma (CTCL), and incorporates lesion size, scale, elevation, erythema, and pigmentation. In a recently completed clinical trial, modified CAILS (mCAILS), eliminating pigmentation, was used to assess lesions of cutaneous lichen planus (LP). Data from this trial was used to propose an optimized scoring system for mCAILS in LP. In the study, 12 patients were assessed using physician global assessment (PGA) and up to 10 lesions per patient were assessed using mCAILS at weeks 0, 1, 2, 3, 4, 8, 12. The original erythema, scale, and elevation 9-level subscores were simplified to 4 levels (none, mild, moderate and severe). A new scoring method for size was created. PGA served as the standard to evaluate the performance of this proposed scoring method. Using mCAILS data, three statistical values: F-value from repeated measure ANOVA, AUC, and repeated measure correlation coefficients were calculated to determine the optimal scoring method for each subscore. Other lesions’ assessments from the study were used to validate the proposed scoring method.