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Introduction <p>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.</p> Methods <p>We used data from three randomized, double-blinded, placebo-controlled clinical trials of rocatinlimab in adults (aged ≥ 18&#xa0;years) (ROCKET-IGNITE and ROCKET-SHUTTLE) and adolescents (aged ≥ 12 to &lt; 18&#xa0;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.</p> Results <p>This psychometric analysis sample used 262 adults (ROCKET-IGNITE, <i>n</i> = 145; ROCKET-SHUTTLE, <i>n</i> = 117) and 109 adolescents (ROCKET-ASTRO, <i>n</i> = 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 (|<i>r</i>| ≥ 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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月9日

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  • Andrew Blauvelt,
  • Kimberly M. Deininger,
  • Joshua Porter,
  • Alexis Sohn,
  • Shanshan Qin,
  • Lori McLeod,
  • Angela J. Rylands,
  • Lauren Nelson

摘要

Introduction

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.

Methods

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.

Results

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.

Conclusions

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.