Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity...

Area of Science:

• Dermatology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• Three patient-reported outcome (PRO) questionnaires were developed to assess atopic dermatitis (AD) symptoms and impacts: Worst Pruritus Numerical Rating Scale (WP-NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS).
• Severity strata are essential for interpreting scores from these PROs in clinical settings and research.

Purpose of the Study:

• To define severity strata for the WP-NRS, ADerm-SS, and ADerm-IS questionnaires in patients with moderate-to-severe atopic dermatitis.
• To establish clear score interpretations for these PROs to facilitate their use in clinical studies and practice.

Main Methods:

• Equipercentile linking analyses were performed using data from a global, randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT03568318).
• The Patient Global Impression of Severity was used as an anchor to define severity strata.
• Analyses were conducted separately for adults and adolescents and subsequently harmonized between the age groups.

Main Results:

• Severity strata were defined for WP-NRS, ADerm-SS (Skin Pain and TSS-7), and ADerm-IS (Sleep, Daily Activities, and Emotional State).
• Specific score ranges were associated with absent, minimal, mild, moderate, and severe categories for each PRO.
• For example, WP-NRS scores of 8-10 were classified as severe.

Conclusions:

• The established severity strata provide intuitive score interpretations for the WP-NRS, ADerm-SS, and ADerm-IS.
• These strata will enhance the utility of these PROs in informing clinical studies and guiding clinical practice for atopic dermatitis management.