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Identifying the Most Relevant Eczema Area and Severity Index Thresholds from the Patient Perspective in Atopic
Lawrence F Eichenfield1,2, Peter A Lio3, Alan D Irvine4
1Departments of Dermatology and Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, USA.
Background:
Atopic dermatitis (AD) is a chronic inflammatory disease significantly impacting patients' quality of life (QoL). While multiple outcome measures exist, a critical gap remains in establishing treatment goals that meaningfully connect improvements in clinician-reported outcome measures (ClinROMs) with patient-reported outcome measures (PROMs).
Objective:
To determine the Eczema Area and Severity Index (EASI) threshold that best corresponds with clinically meaningful and optimal treatment responses in PROMs, linking ClinROMs and PROMs.
Methods:
LIBERTY AD CHRONOS, a randomized controlled trial, included adult patients treated with dupilumab 300 mg every 2 weeks plus topical corticosteroids. In this post-hoc analysis of the trial, repeated-measures regression analysis was used to quantify the relationship between EASI and improvements in PROMs.
Results:
Most clinically meaningful responses in PROMs were associated with 50-75% EASI improvement from baseline with the greatest impact on achieving clinically meaningful and optimal PROM responses when transitioning from EASI-50 to EASI-75 and minimal additional benefit when transitioning from EASI-75 to EASI-90 and EASI-90 to EASI-100. Two PROM composite end points, encompassing treatment responses in symptoms and QoL, confirmed these findings.
Conclusions:
This analysis bridges clinician-reported EASI with PROMs, demonstrating that EASI-75 aligns closely with clinically meaningful and optimal treatment responses from the patient perspective, providing a treatment goal that is both meaningful to patients and visually quantifiable for physicians in moderate-to-severe AD [Graphical abstract available online].
Gov Identifier:
NCT02260986 (registered October 06, 2014).
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