TRIAL DESIGNS AND ENDPOINTS

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 numeric rating scale.

Sandra

Age 55

Living with PN for 5 years

Battling widespread nodules

The nodules are not
only uncomfortable but
unsightly. And I have them
all over. I need to get this
under control.

Image of an actual adult patient
with PN. Story is inspired by people
who suffer from PN.

Image of an actual adult patient
with PN. Story is inspired by people
who suffer from PN.

Signs and symptoms

  • Has >100 nodules on the body that are hard to cover up
  • Worries that people think the condition is contagious

Treatment and goals

  • Has tried several prescription therapies, including topical steroids and steroid injections into the nodules
  • Wants clearer skin—especially in more visible areas—and less itch