Work

Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis

Year: 2026

Type: article

Abstract: Atopic dermatitis (AD) is a chronic inflammatory skin condition often associated with skin pain and sleep disturbance. The AD Skin Pain Numeric Rating Scale (SP-NRS) and Sleep Disturbance NRS (SD-NRS) are single-item patient-reported outcome measures developed to assess AD-related skin pain and sleep disturbance severity, respectively, in AD clinical trials. We used data from three randomized, double-blinded, placebo-controlled clinical trials of rocatinlimab in adults (aged ≥ 18 years) (ROCKET-IGNITE and ROCKET-SHUTTLE) and adolescents (aged ≥ 12 to < 18 years) (ROCKET-ASTRO) with moderate-to-severe AD to assess the reliability, validity, and responsiveness of the AD SP-NRS and SD-NRS. Clinical outcome assessments (COAs) supported the psychometric evaluation, and we estimated meaningful change thresholds for the AD SP-NRS and SD-NRS using anchor-based methods, which we confirmed with distribution-based methods. We included data from both the treatment arm and placebo in our analyses, and we analyzed results from adult and adolescent populations separately. This psychometric analysis sample used 262 adults (ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117) and 109 adolescents (ROCKET-ASTRO, n = 109), subsets from the initial data cuts of the respective clinical trials, in the psychometric analysis sample. Both AD SP-NRS and SD-NRS scores demonstrated high test–retest reliability for both adults and adolescents (intraclass correlation coefficients ≥ 0.80) and moderate-to-strong (|r| ≥ 0.30) positive correlations with most supporting COAs. Anchor-based meaningful within-patient change threshold ranges derived for AD SP-NRS and SD-NRS scores supported both 3-point and 4-point improvement thresholds for characterizing clinically meaningful changes. The AD SP-NRS and SD-NRS are reliable, valid, and responsive measures for assessing moderate-to-severe AD in adults and adolescents in clinical trials. The meaningful change thresholds identified in this study can be used in future clinical trials to interpret treatment effects. Atopic dermatitis (AD), also known as eczema, is a common skin condition that causes itching, skin pain, and trouble sleeping. To understand how well new medications work, doctors use questionnaires to track symptoms. We created questionnaires called the Skin Pain Numeric Rating Scale, which measures the intensity of skin pain related to AD, and the Sleep Disturbance Numeric Rating Scale, which measures how much AD affects sleep. In this study, we evaluated how well these tools measure the severity of skin pain and sleep disturbance over the past 24 h in both adults and children/teenagers. Our findings show that these questionnaires reliably track symptom severity and the intensity changes over time, confirming that these questionnaires are suitable for use in clinical trials.

Source: Dermatology and Therapy

DOI: 10.1007/s13555-025-01634-5