Positive topline results from a phase 3 trial evaluating the efficacy and safety of dupilumab in adults with uncontrolled prurigo nodularis showed that it met primary and all key secondary endpoints.

The multicenter, randomized, double-blind, placebo-controlled, parallel-group PRIME2 study (ClinicalTrials.gov Identifier: NCT04202679) included 160 patients 18 years of age and older with prurigo nodularis inadequately controlled with topical prescription therapies or when those therapies were not advisable. Patients were randomly assigned to receive dupilumab (n=78) or placebo (n=82) 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 worst-itch numeric rating scale (WI-NRS) score of 4 or greater at week 12 from baseline. Key secondary endpoints included the proportion of patients with improvement in itch at week 24 and the proportion of patients with Investigator’s Global Assessment score of clear ‘0’ or almost clear ‘1’ skin at week 24.

Findings showed that 37% of patients treated with dupilumab achieved a clinically meaningful reduction in itch at week 12 compared with 22% of those treated with placebo (P =.0216). Moreover, 58% of dupilumab-treated patients had a clinically meaningful reduction in itch at week 24 compared with 20% of placebo-treated patients (P <.0001). A greater proportion of patients in the dupilumab arm also achieved clear or almost clear skin at week 24 compared with those in the placebo arm (45% vs 16%; P <.0001).


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Patients in the dupilumab arm also demonstrated significantly greater improvements in measures of health-related quality of life, skin pain, and symptoms of anxiety and depression. The most common treatment-emergent adverse events were conjunctivitis and herpes viral infection.

“We are encouraged that patients in this trial experienced a significant reduction in itch and skin lesions, especially given that prior to enrollment nearly all patients had severe itch and nearly 40% had 100 or more nodules covering their body,” said John Reed, MD, PhD, Global Head of Research and Development at Sanofi. “These data are an important step forward in furthering our knowledge of the role that targeting IL-4 and IL-13 can play in the treatment of skin diseases that cause extreme itch.”

Dupilumab is 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.

Reference

Dupixent® (dupilumab) is the first biologic to significantly reduce itch and skin lesions in phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease. News release. Regeneron Pharmaceuticals, Inc. Accessed October 22, 2021. https://www.prnewswire.com/news-releases/dupixent-dupilumab-is-the-first-biologic-to-significantly-reduce-itch-and-skin-lesions-in-phase-3-trial-for-prurigo-nodularis-demonstrating-the-role-of-type-2-inflammation-in-this-disease-301406425.html