TRIAL DESIGNS AND RESULTS

A total of 311 adults in PRIME and PRIME2 with prurigo nodularis were randomized to DUPIXENT or placebo. All DUPIXENT-treated participants received 300 mg Q2W after a 600 mg loading dose. At baseline, participants had an average WI-NRS score of ≥7 (on a scale of 0 to 10) and ≥20 prurigo nodularis lesions in total at screening visit and Day 1 (inclusion criteria). In addition, ≈60% of participants were on a background therapy of TCS/TCI, and 43% had a history of atopy (defined as having a medical history of atopic dermatitis, allergic rhinitis/rhinoconjunctivitis, asthma, or food allergy). No participants had moderate-to-severe atopic dermatitis at study entry or at any time 6 months prior to study entry (exclusion criteria).1,2

The primary endpoint was the proportion of participants with improvement in WI-NRS by ≥4 points from baseline at Week 24 (60% of participants treated with DUPIXENT vs 18% with placebo in PRIME, P<0.001) and Week 12 (37% of participants treated with DUPIXENT vs 22% with placebo in PRIME2, P=0.022). Other endpoints included the proportion of participants with IGA PN-S 0 or 1 at Week 24 (the equivalent of 0 to 5 nodules; 48% of participants treated with DUPIXENT vs 18% with placebo in PRIME, P<0.001; 45% of participants treated with DUPIXENT vs 16% with placebo in PRIME2, P<0.001) and the proportion of participants who achieved both ≥4-point improvement in WI-NRS and IGA PN-S 0 or 1 at Week 24 (39% of participants treated with DUPIXENT vs 9% with placebo in PRIME, P<0.001; 32% of participants treated with DUPIXENT vs 9% with placebo in PRIME2, P<0.001).1,2

IGA PN-S, Investigator’s Global Assessment PN-Stage; Q2W, once every 2 weeks; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids; WI-NRS, Worst Itch numerical rating scale.

Joseph

Age 54

has lived with prurigo nodularis
for 10 years

Struggling with topicals

I’ve picked and scratched at the
persistent itch and unsightly
nodules for 10+ years. Now with
DUPIXENT, I have it under control.

Not an actual patient.
Story is inspired by people who have prurigo nodularis.
Not an actual patient.
Story is inspired by people who have prurigo nodularis.

My signs and symptoms

  • Between 50 and 70 nodules on trunk and arms
  • Intense itch-scratch cycle that resulted in nodules and scarring
  • Bothersome itch, even where nodules were not present

My treatment and goals

  • Previous management approaches have been unsuccessful
  • A therapy to improve my itch and reduce nodules is needed