Dupixent shows positive phase 3 results in prurigo nodularis
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Dupixent reduced itch and lesions in patients with prurigo nodularis in a phase 3 study, Sanofi and Regeneron announced in a press release.
The randomized, double-blind, placebo-controlled phase 3 PRIME2 trial, part of the LIBERTY-PN PRIME program, included 160 adults with prurigo nodularis. Subjects received Dupixent (dupilumab), a fully human monoclonal interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor, or placebo every 2 weeks for 24 weeks.
The trial found 37% of those treated with Dupixent had a clinically meaningful reduction in itch, compared to 22% of those treated with placebo at week 12 (P = .0216).
At week 24, 58% of those in the Dupixent group had a clinically meaningful reduction in itch, compared to 20% of placebo-treated patients (P < .0001).
Clear or almost clear skin was also recorded in 45% of those in the Dupixent group, compared to 16% of those in the placebo group (P < .0001).
“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,”
John Reed, MD, PhD, global head of research and development at
Sanofi, said in the release. “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.”
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Press Release
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