Dupilumab improves pruritus and skin lesions in patients with prurigo nodularis: Pooled results from 2 phase 3 trials (LIBERTY-PN PRIME and PRIME2)
Journal
JAAD International
Journal Volume
16
Start Page
163-174
ISSN
2666-3287
Date Issued
2024-09
Author(s)
Yosipovitch, Gil
Kim, Brian S.
Kwatra, Shawn G.
Mollanazar, Nicholas K.
Ständer, Sonja
Satoh, Takahiro
Mendes-Bastos, Pedro
et al.
Abstract
Background: Phase 3 PRIME/PRIME2 trials independently demonstrated efficacy and an acceptable safety profile of dupilumab adults with moderate-to-severe prurigo nodularis.
Objective: To obtain a more precise estimate of onset and magnitude of treatment effect using PRIME/PRIME2 pooled data.
Methods: In PRIME/PRIME2, patients were randomized to dupilumab or placebo for 24 weeks. Pooled analysis assessed proportion of patients achieving clinically meaningful improvement in itch, clear/almost-clear skin, or both; at weeks 12 and 24; overall and by demographic subgroups and changes from baseline to week 24 in symptoms, signs, and quality of life.
Results: Patients receiving dupilumab (n = 153) vs placebo (n = 158) experienced significant improvements in all tested endpoints. At week 24, 90 (58.8%) dupilumab-treated vs 30 (19.0%) placebo-treated patients achieved clinically meaningful improvement in itch, 71 (46.4%) vs 27 (17.1%) clear/almost clear skin, and 54 (35.3%) vs 14 (8.9%) achieved both (P < .0001 for all). Treatment benefits were independent of baseline demographics. Safety to week 36 was generally consistent with the known dupilumab safety profile.
Limitations: On-treatment data limited to 24 weeks.
Conclusions: Pooled analysis confirmed improvements reported in individual trials and revealed earlier effect onset in itch and skin pain. Dupilumab treatment showed benefits across demographics.
Subjects
Dermatology Life Quality Index (DLQI)
Investigator’s Global Assessment for Prurigo Nodularis Stage (IGA PN-S)
Worst Itch Numerical Rating Scale (WI-NRS)
dupilumab
prurigo nodularis
Publisher
Elsevier BV
Type
journal article