Phase III trial of Dupixent meets primary and secondary endpoints in prurigo nodularis.

The data confirm the positive results that were previously reported from the Phase III PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch.

In the Phase III PRIME trial, topline results comparing Dupixent (n=75) to placebo (n=76) showed at week 24: More than three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline, the primary endpoint: 60% of Dupixent patients compared to 18% of placebo patients (p <0.0001). nearly three times as many dupixent patients achieved clear or almost clear skin, a secondary endpoint: 48% of dupixent patients compared to 18% of placebo patients (p="0.0004)." dupixent patients experienced significantly greater improvements in measures of overall health-related quality of life, skin pain, and symptoms of anxiety and depression.></0.0001).

The safety results of the trial were consistent what was observed in PRIME2 and were also generally consistent with the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, overall rates of treatment-emergent adverse events were 71% for Dupixent and 63% for placebo. Adverse events most commonly observed with Dupixent included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo). Additionally, 0% of Dupixent patients and 4% of placebo patients discontinued treatment due to adverse events prior to week 24. Consistent with published literature for the atopic dermatitis trials, numerically lower rates of skin infections were seen with Dupixent in this trial (4% Dupixent, 9% placebo). Detailed results from this trial will be presented at an upcoming medical congress.