Why carry out this study?

The Investigator’s (Static) Global Assessment [I(S)GA] is recommended by the US Food and Drug Administration for assessment of the severity of atopic dermatitis (AD) in clinical trials, whereas the Eczema Area and Severity Index (EASI) is recommended by the Harmonizing Outcome Measures for Eczema initiative for the same purpose.

In phase 3 clinical trials of crisaborole ointment, 2%, the primary outcome was assessed using the ISGA.

The objective of the present analysis was to translate ISGA scores to EASI scores using clinical trial data, thereby aiding in the interpretability of trial data that use ISGA-based endpoints.

What was learned from this study?

This study showed, through simulation analysis, the consistency of results obtained using mapped EASI scores across key clinical outcomes measures commonly reported in clinical trials in AD (i.e., % change from baseline, EASI-50, EASI-75, EASI-90).

This analysis provides an approach that may be useful in other studies to further assist in interpretability of ISGA reported in clinical studies.