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.

Sofia

Age 45

has lived with prurigo nodularis
for 2 years

Tried topicals multiple times

The itch never let up, and
scratching made it worse—the
nodules would scab and hurt. 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

  • Around 50 nodules on my back and extremities
  • Intense itching and scratching
  • Itch present even where nodules were not active

My treatment and goals

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