To establish standardized definitions for disease activity states in atopic dermatitis for clinical trials and translational research, addressing a critical gap in clinical benchmarks.
Approach:
Key Findings:
Four disease states were defined: low disease activity, very low disease activity, on-drug complete control, and off-drug remission.
High agreement (95%-97%) was achieved on the final definitions.
The validated Investigator Global Assessment for Atopic Dermatitis and Eczema Area and Severity Index were favored for clinician-reported measures.
Interpretation:
The standardized definitions aim to improve consistency in clinical trials and facilitate comparability across studies in atopic dermatitis by providing clear benchmarks for disease activity.
Limitations:
Uneven geographic representation and variation in participation across Delphi rounds may affect the generalizability of the findings.
Limited representation of patients with AD who were not clinicians or researchers may bias the outcomes.
Conclusion:
The IEC framework provides a foundation for harmonized trial design and regulatory evaluation, with plans for future integration of patient-priority outcomes to enhance relevance.
