ArticleDermatology and therapy2026
Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis.
Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05704738 (A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab), which is not on this map. Not yet cited in PubMed.
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A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
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Abstract
introductionAtopic 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.
methodsWe 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.
resultsThis 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.
conclusionsThe 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.
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