Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials

Gil Yosipovitch, Nicholas Mollanazar, Sonja Ständer, Shawn G. Kwatra, Brian S. Kim, Elizabeth Laws, Leda P. Mannent, Nikhil Amin, Bolanle Akinlade, Heribert W. Staudinger, Naimish Patel, George D. Yancopoulos, David M. Weinreich, Sheldon Wang, Genming Shi, Ashish Bansal, John T. O’Malley

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47 Scopus citations

Abstract

Prurigo nodularis (PN) is a chronic inflammatory skin disease with intensely pruritic nodules. The LIBERTY-PN PRIME and PRIME2 phase 3 trials enrolled adults with PN with ≥20 nodules and severe itch uncontrolled with topical therapies. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13. Patients were randomized 1:1 to 300 mg dupilumab or placebo subcutaneously every 2 weeks for 24 weeks. The primary endpoint was pruritus improvement, measured by proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2). Key secondary endpoints included nodule number reduction to ≤5 at week 24. PRIME and PRIME2 enrolled 151 and 160 patients, respectively. Both trials met all the pre-specified primary and key secondary endpoints. A ≥4-point WI-NRS reduction at week 24 in the dupilumab and placebo arms was achieved by 60.0% and 18.4% of patients, respectively, in PRIME (95% confidence interval (CI), 27.8–57.7 for the difference, P < 0.001) and at week 12 by 37.2% and 22.0% of patients, respectively, in PRIME2 (95% CI, 2.3–31.2; P = 0.022). Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN. Safety was consistent with the known dupilumab safety profile. ClinicalTrials.gov identifiers: NCT04183335 and NCT04202679 .

Original languageEnglish
Pages (from-to)1180-1190
Number of pages11
JournalNature Medicine
Volume29
Issue number5
DOIs
StatePublished - May 2023

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