When did patients experience itch relief for their prurigo nodularis?

Itch reduction (as measured by the proportion of patients with a ≥4-point improvement in WI-NRS) was the primary endpoint in two 24-week randomized, double-blind, placebo-controlled, multicenter, parallel-group studies (PRIME and PRIME2).^1,2 In the PRIME trial, a nominal difference was observed at Week 4 (19% with DUPIXENT vs 4% with placebo), with significant improvement at Week 24.³

In PRIME, the proportion of DUPIXENT patients who achieved ≥4-point improvement in WI-NRS was ≈3 times more than placebo at Week 24 (60% with DUPIXENT vs 18% with placebo; P<0.001, primary endpoint)^1,2

Definitive conclusions cannot be made for results earlier than 24 weeks in PRIME. Data were not multiplicity controlled.

PRIME2

A nominal difference in itch improvement was observed at Week 11 (33% with DUPIXENT vs 17% with placebo).³ At Week 12, 37% of DUPIXENT patients achieved ≥4-point improvement in WI-NRS vs 22% with placebo; P=0.022 (primary endpoint). At Week 24, 58% of DUPIXENT patients achieved significant itch relief vs 20% with placebo; P<0.001 (secondary endpoint).^1,2

Definitive conclusions cannot be made for timepoints other than Week 12 and 24 in PRIME2. Data were not multiplicity controlled.

IN A POOLED ANALYSIS OF PRIME AND PRIME2

Itch improvement observed after first dose (as measured at Week 2)^3,4

7.9% of DUPIXENT patients saw ≥4-point improvement in WI-NRS at Week 2 vs 1.9% with placebo
59% of DUPIXENT patients had ≥4-point improvement in WI-NRS at Week 24 vs 19% with placebo

Definitive conclusions cannot be made for these results as the data were not multiplicity controlled and P values were nominal.

REVIEW WI-NRS RESULTS