Detailed positive results from the Phase 3 PRIME2 trial show Dupixent® (dupilumab) significantly reduced itch and skin lesions compared to placebo in adults with uncontrolled prurigo nodularis. Findings were presented in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting.

Regeneron Pharmaceuticals, Inc. and Sanofi previously announced topline results from PRIME2 and a second trial, called PRIME, investigating the use of Dupixent in prurigo nodularis. 

"Prurigo nodularis is a relentless and often misunderstood itchy skin disease that leaves many patients with uncontrolled symptoms such as unbearable itch and painful skin lesions, along with a significantly impaired quality of life that should not be underestimated," says Gil Yosipovitch, MD, Professor of Dermatology at the Miller School of Medicine at University of Miami, Director of the Miami Itch Center and principal investigator of the trial. "These positive results are the first time a Phase 3 trial has demonstrated that targeting key drivers of type 2 inflammation, IL-4 and IL-13, with dupilumab significantly improved itch and skin lesions in this highly burdensome disease."

The randomized, placebo-controlled PRIME2 trial met its primary and all key secondary endpoints. Data presented at AAD 2022 show 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients at week 12, the primary endpoint.

Nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline at week 24: 58% of Dupixent patients compared to 20% of placebo patients.

Nearly three times as many Dupixent patients achieved clear or almost clear skin at week 24: 45% of Dupixent patients compared to 16% of placebo patients.

Safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. For the 24-week treatment period, overall rates of adverse events were generally similar between Dupixent and placebo groups (57% Dupixent, 51% placebo). Adverse events that were more commonly (≥5%) observed with Dupixent were herpes viral infections (7% Dupixent, 0% placebo). A lower rate of skin infections was observed with Dupixent (5% Dupixent, 9% placebo). Additionally, 3% of Dupixent patients and 30% of placebo patients discontinued prior to week 24.

Results from the confirmatory PRIME trial will be presented at an upcoming medical congress. Data from both trials will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis, which are planned to begin in the first half of 2022.

In total, 21 scientific abstracts evaluating the safety and efficacy of Dupixent in patients with atopic dermatitis in different age groups, as well as investigational indications of prurigo nodularis and chronic spontaneous urticaria will be presented at the congress.

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