Background <p>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).</p> Objective <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>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].</p> Clinicaltrials.gov Identifier <p>NCT02260986 (registered October 06, 2014).</p>

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Identifying the Most Relevant Eczema Area and Severity Index Thresholds from the Patient Perspective in Atopic Dermatitis Treatment

  • Lawrence F. Eichenfield,
  • Peter A. Lio,
  • Alan D. Irvine,
  • Christian J. Apfelbacher,
  • Kenji Kabashima,
  • Amy H. Praestgaard,
  • Zhixiao Wang,
  • Mike Bastian

摘要

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].

Clinicaltrials.gov Identifier

NCT02260986 (registered October 06, 2014).