Patients with prurigo nodularis treated with dupilumab experienced a clinically significant reduction in itch, according to new phase 3 data.
The randomized, double-blind, placebo-controlled PRIME study (ClinicalTrials.gov Identifier: NCT04183335) evaluated the efficacy and safety of dupilumab in 151 adults with inadequately controlled prurigo nodularis. Patients were randomly assigned to receive dupilumab (n=75) or placebo (n=76) every 2 weeks with or without topical treatments (low- or medium-dose topical corticosteroids or topical calcineurin inhibitors were continued if patients were using these at randomization).
The primary endpoint was the proportion of patients with improvement (reduction) in the worst-itch numeric rating scale (WI-NRS) by at least 4-points at week 24 from baseline. The key secondary endpoint was the proportion of patients with Investigator’s Global Assessment score of clear ‘0’ or almost clear ‘1’ skin at week 24.
Results showed that 60% of patients treated with dupilumab had a clinically meaningful reduction in itch at week 24 compared with 18% of those who received placebo (P <.0001). Moreover, 48% of patients in the dupilumab arm achieved clear or almost clear skin vs 18% of the placebo arm (P =.0004). Significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression were also observed with dupilumab.
The safety profile of dupilumab was consistent with that previously reported in the phase 3 PRIME2 study (ClinicalTrials.gov Identifier: NCT04202679), and was consistent with the known safety profile of dupilumab in its approved indications. The most common adverse reactions were nasopharyngitis and headache.
“These results strengthen our understanding of the underlying biology of prurigo nodularis and are encouraging as we seek to help patients severely impacted by symptoms like unbearable itch, skin lesions, stinging and burning,” says Naimish Patel, MD, Head of Global Development, Immunology and Inflammation at Sanofi. “The decision to accelerate directly into a phase 3 clinical trial for prurigo nodularis was driven by our conviction that type 2 inflammation is a key driver of this highly pruritic disease and underscores our commitment to quickly bring novel treatments to patients who are in urgent need of new options.”
Dupilumab is currently marketed under the brand name Dupixent® and is approved to treat moderate to severe asthma, moderate to severe atopic dermatitis, and chronic rhinosinusitis with nasal polyposis.
Second positive phase 3 Dupixent® (dupilumab) trial confirms significant improvements for patients with prurigo nodularis. News release. Regeneron Pharmaceuticals, Inc. Accessed January 19, 2022. https://www.prnewswire.com/news-releases/second-positive-phase-3-dupixent-dupilumab-trial-confirms-significant-improvements-for-patients-with-prurigo-nodularis-301463476.html