Dupixent Reduces Itch, Clears Skin in Prurigo Nodularis Phase 3 Trial

Data from a pivotal Phase 3 trial show that Dupixent® (dupilumab) reduced itch and led to higher rates of skin clearance than placebo among adults with uncontrolled prurigo nodularis.

In the Phase 3 PRIME2 trial, 37 percent of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22 percent of placebo patients at week 12, the primary endpoint. At week 24, 58 percent of Dupixent patients experienced a clinically meaningful reduction in itch from baseline, compared to 20 percent of placebo patients.

At 24 weeks, patients receiving active treatment were nearly three times as likely to achieve clear or almost clear skin. Forthy0five percent of Dupixent patients achieved clear or almost clear skin, compared to 16 percent of placebo patients (p<0.0001).

Additionally, Dupixent patients experienced significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression, compared to controls.

Safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. Treatment-emergent adverse events occurred with generally similar rates between Dupixent and placebo groups.

“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 percent had 100 or more nodules covering their body,” says 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. We are committed to continuing to leverage the robust Dupixent clinical program to transform the understanding of the science behind a number of type 2 inflammatory diseases and look forward to presenting the full results at a future medical congress.”

The use of Dupixent, from Sanofi and Regeneron, in prurigo nodularis is investigational, and the safety and efficacy have not been fully evaluated by any regulatory authority.