Positive results from the phase 3 PRIME2 trial – part of the LIBERTY-PN PRIME clinical programme – assessing the safety and effectiveness of Sanofi and Regeron’s Dupixent (dupilumab) were shared in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting.
Previously, Sanofi and Regeneron announced topline results from PRIME2 and a second trial called PRIME, investigating the use of Dupixent in adults with uncontrolled prurigo nodularis. It was shown that Dupixent significantly reduced itch and skin lesions compared to placebo in both trials.
21 scientific abstracts in total were presented at the Congress, which assessed the safety and effectiveness of Dupixent in patients with atopic dermatitis in various age groups, as well as investigational indications – prurigo nodularis and chronic spontaneous urticaria.
Prurigo nodularis produces an intense and persistent itch in patients diagnosed with the condition, with thick skin lesions – called nodules – that can cover the body. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases, because of the extreme itch and is comparable to other chronic diseases that can negatively impact mental health.
Topical steroids are typically prescribed, but are associated with safety risks when used long term. In the US, there are around 75,000 people who are unable to control their condition with systemic therapy, reinforcing the need for an accessible treatment.
Gil Yosipovitch, Professor of Dermatology, Miller School of Medicine, University of Miami and principal investigator of the PRIME2 trial, said: “These positive results are the first time a phase 3 trial has demonstrated that targeting key drivers of type 2 inflammation with dupilumab significantly improved itch and skin lesions in this highly burdensome disease.”
The PRIME2 trial – a randomised, placebo-controlled study – met primary and all key secondary endpoints. It demonstrated that 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, while almost three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline at week 24.
Moreover, almost three times as many Dupixent patients had clear or almost clear skin at week 24 – 45% of Dupixent patients compared to 16% of placebo patients.
The results from both trials will form the foundation of submissions for regulatory authorities worldwide for the use of Dupixent in prurigo nodularis, which are planned to start in the first half of 2022.