Slide 1: Psychometric Validation of WI-NRS in Cold Urticaria (poster)
Scan QR code to view poster Psychometric Validation of the Worst Itch Numeric Rating Scale (WI-NRS) as a Patient-Reported Outcome (PRO) in Cold Urticaria: Data from a Clinical Trial of Barzolvolimab M. Metz,1,2 L. Podger,3 A. M. Giménez-Arnau,4 D. Serrano,3 B. Bloom,5 H. Lu,5 P. Golden,5 J. A. Berns
Slide 2: Psychometric Validation of the Worst Itch Numeric Rating Scale (WI-NRS) as a PRO in Cold Urticaria
Psychometric Validation of the Worst Itch Numeric Rating Scale (WI-NRS) as a Patient-Reported Outcome (PRO) in Cold Urticaria: Data from a Clinical Trial of Barzolvolimab M. Metz,1,2 L. Podger,3 A. M. Giménez-Arnau,4 D. Serrano,3 B. Bloom,5 H. Lu,5 P. Golden,5 J. A. Bernstein6 1Institute of Allergol
Slide 3: Introduction
INTRODUCTION • Cold urticaria (ColdU), a type of chronic inducible urticaria, is characterized by the occurrence of itchy wheals with or without angioedema after exposure to cold stimuli over a period of >6 weeks1 • Itch, the most frequently reported ColdU symptom, has been understudied in prior cli
Slide 4: Methods
METHODS • Psychometric validation of the WI-NRS was conducted using data from patients in a Phase 2 trial of barzolvolimab (NCT05405660; 2 treatment arms [150 mg every 4 weeks or 300 mg every 8 weeks] vs placebo) and followed patient-focused drug development guidance on the use of meaningful patient
Slide 5: Methods (cont'd)
METHODS (CONT’D) • Psychometric evaluation of WI-NRS included the following 5 core analyses, as detailed below: Psychometric analyses: definitions and time points Psychometric What question does this analysis Statistical test used & analysis: answer? success criteria: Timepoints: Screening Baseline
Slide 6: Methods (cont'd): Baseline demographics and disease characteristics
METHODS (CONT’D) • Baseline demographics and disease characteristics of the WI-NRS validation subgroup were similar to the full trial ColdU cohort Baseline demographics and disease characteristics of WI-NRS validation subgroup Patients with Patients with ColdU (n=89) ColdU (n=89) Age, y (SD) 40.2 (1
Slide 7: Measurements of itch with WI-NRS are reliable and reproducible
Measurements of itch with WI-NRS are reliable and reproducible The psychometric performance of WI-NRS, a patient-reported measure of itch, was robust in patients with ColdU • Test-retest reliability for WI-NRS indicated strong reproducibility; correlations between weekly average scores at screening
Slide 8: WI-NRS demonstrated strong correlations with conceptually related measurements
WI-NRS demonstrated strong correlations with conceptually related measurements, suggesting robust convergent validity • 94% (16/17) of correlations between weekly average WI-NRS scores and convergent validators (ie, external instruments/scores hypothesized to measure similar constructs) met or excee
Slide 9: WI-NRS can detect differences in itch in known groups of patients
WI-NRS can detect differences in itch in known groups of patients with externally validated differences in ColdU symptom severity • Weekly average WI-NRS scores at baseline were able to clearly distinguish between known groups of patients stratified by patient global impression of severity (PGIS) ca
Slide 10: WI-NRS can detect improvements in itch severity over time
WI-NRS can detect improvements in itch severity over time in patients with externally validated changes in symptom severity • Compared with the “no change” cohort (0-point change in PGIS scores from baseline to week 12), 0 * patients in the PGIS-defined week 12 in WI-NRS scores Change from baseline
Slide 11: Over 50% of treated patients achieved the 2.64-point decrease in WI-NRS
Over 50% of treated patients achieved the 2.64-point decrease in WI-NRS required for meaningful within-patient improvement (MWPI) in itch • In patients stratified into patient global impression of change (PGIC) anchor groups (“no change” [score of 3], “a little better [score of 2], “much better” [sc
Slide 12: Conclusions
CONCLUSIONS • These results provide robust evidence for the reliability and validity of WI-NRS, with all measurements meeting the pre-specified success criteria, confirming it is a psychometrically sound tool to measure itch in patients with ColdU • These analyses support the fit-for-purpose status
Slide 13: Thank You!
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