International Eczema Council Definitions of Low Disease Activity and Remission in Atopic Dermatitis

医学 特应性皮炎 德尔菲法 皮肤病科 梅德林 疾病 基础(证据) 临床试验 疾病控制 家庭医学 替代医学 随机对照试验 生活质量(医疗保健) 重症监护医学 疾病严重程度 德尔菲
作者
J F Merola,Beth A. Childs,Brooke R. Bartley,Robert Bissonnette,Thomas Bieber,Emma Guttman‐Yassky,Amy S. Paller,Eric L. Simpson,April W. Armstrong,Alan D. Irvine
出处
期刊:JAMA Dermatology [American Medical Association]
标识
DOI:10.1001/jamadermatol.2026.0662
摘要

Importance: Advances in targeted therapeutics have made substantial response states in atopic dermatitis (AD) increasingly attainable. However, the field lacks standardized, internationally endorsed definitions of low disease activity (LDA), very low disease activity (vLDA), and remission to benchmark treatment response, support regulatory clarity, and enable consistent cross-trial comparisons. Objective: To develop consensus-based definitions of LDA, vLDA, and remission in AD that accommodate regional regulatory frameworks and to refine associated terminology for clinical and research use. Evidence Review: A steering committee from the International Eczema Council (IEC) conducted a targeted systematic literature review. PubMed was searched in July 2024 for studies from January 1, 2004, through December 31, 2024, using combinations of terms related to atopic dermatitis, clinician-reported outcomes, patient-reported outcomes, disease control states, pruritus measures, and disease activity constructs. Evidence was appraised using the Oxford Centre for Evidence-Based Medicine criteria. Key conceptual domains were identified to inform a 3-round sequential modified Delphi process conducted from January to July 2025. Panelists (current IEC members with recognized AD expertise) iteratively reviewed feedback, refined thresholds, and provided qualitative rationale. Predefined criteria distinguished consensus (≥70% agreement), near consensus (60%-69%), and nonconsensus (<60%), guiding which cutoffs were adopted, revised, or excluded. Findings: Of the 151 experts invited, 61 (40%) completed round 1, 37 (25%) completed round 2, and 103 (68%) completed round 3. Responses from participants were globally distributed (North America: 59 [29%]; Europe: 47 [23%]; Asia-Pacific: 60 [30%]; Latin America 27 [13%]; Middle East and Africa: 7 [3%]), including 131 clinician-researchers (66%), 59 clinicians (30%), and 9 researchers (5%); 17 respondents (8%) self-identified as individuals with lived AD experience and/or patient advocacy representatives. A total of 43 panelists (74%) endorsed a modular framework that stratifies clinician-reported signs and patient-reported symptoms as complementary components of remission (eg, remission [signs], remission [symptoms], remission [overall]) in the initial survey. Final consensus definitions included LDA (validated Investigator Global Assessment for Atopic Dermatitis [vIGA] = 2 or Eczema Area and Severity Index [EASI] ≤ 7 plus Peak Pruritus Numerical Rating Scale [PP-NRS] ≤ 4), vLDA (vIGA-AD = 0/1 or EASI ≤ 3 plus PP-NRS = 0/1), on-drug complete control (ie, complete control while taking AD-related medications, excluding only nonmedicated moisturizers/emollients, defined as vIGA-AD = 0 or EASI = 0 plus PP-NRS = 0/1 for ≥6 months), and off-drug remission (ie, remission after stopping treatment, defined as vIGA-AD = 0 or EASI = 0 for plus PP-NRS = 0/1 maintained for ≥12 months after treatment). Conclusions and Relevance: This modified Delphi initiative establishes a globally endorsed, expert-derived framework defining LDA, vLDA, on-drug complete control, and off-drug remission in AD. These standardized, clinically meaningful definitions provide a foundation for harmonized trial design, regulatory evaluation, and longitudinal comparative effectiveness research. By promoting consistent assessment of disease control across studies, this framework advances the field toward evidence-based, treat-to-target AD strategies.
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