All primary and key secondary end points met in two phase 3 trials of adults with PN with ≥20 nodules
By Elana Gotkine HealthDay Reporter
WEDNESDAY, May 10, 2023 (HealthDay News) — For adults with prurigo nodularis (PN), dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL-13, demonstrates clinically meaningful and significant improvements in itch and skin lesions in two phase 3 trials (LIBERTY-PN PRIME and PRIME2), according to a study published online May 4 in Nature Medicine.
Gil Yosipovitch, M.D., from the University of Miami, and colleagues randomly assigned adults with PN with ≥20 nodules and severe itch uncontrolled with topical therapies to dupilumab or placebo subcutaneously every two weeks for 24 weeks. Pruritus improvement, measured by the proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2), was the primary end point.
A total of 151 and 160 patients were enrolled in PRIME and PRIME2, respectively. The researchers found that both trials met all primary and key secondary end points. A ≥4-point reduction in WI-NRS was achieved at week 24 by 60.0 and 18.4 percent of patients in the dupilumab and placebo arms, respectively, in PRIME and at week 12 by 37.2 and 22.0 percent of patients, respectively, in PRIME2.
“These positive studies support the involvement of type 2 cytokines in driving PN disease pathogenesis and the targeting of the IL-4/IL-13 axis as a novel therapeutic paradigm for patients with PN,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.
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