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). In the PRIME trial, a nominal difference was observed at Week 4 (19% with DUPIXENT vs 4% with placebo), with significant improvement at Week 24.1-3

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

PRIME2

  • 37% of DUPIXENT patients achieved a meaningful itch response at Week 12 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

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 had ≥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