Efficacy demonstrated in 2 pivotal Phase 3 trials, PRIME and PRIME21,2

Randomized

PRIME (N=151)
DUPIXENT
300 mg Q2W after
600 mg loading
dose for 24 weeks (n=75) Matched placebo
for 24 weeks
(n=76)

PRIME2 (N=160)
DUPIXENT
300 mg Q2W after
600 mg loading
dose for 24 weeks (n=78) Matched placebo
for 24 weeks
(n=82)
Study population

Patients (≥18 years) with:
  • Severe pruritus (WI‑NRS ≥7 on a scale of 0 to 10)
  • Greater than or equal to 20 nodular lesions
  • Disease that was not adequately controlled with topical prescription therapies or when those therapies were not advisable

≈60% of trial participants were on a stable regimen of background TCS/TCI therapy.
  • The remaining ≈40% of participants received DUPIXENT monotherapy for their PN or placebo
57% of patients did not have a history of atopy.
  • History of atopy was defined as having a medical history of one or more of the following:
    • Atopic dermatitis
    • Allergic rhinitis/rhinoconjunctivitis
    • Asthma
    • Food allergy
Primary endpoints

PRIME (N=151)
Week 24
  • Proportion of subjects with ≥4‑point improvement in WI‑NRS
PRIME2 (N=160)
Week 12
  • Proportion of subjects with ≥4‑point improvement in WI‑NRS
Key secondary endpoints

Week 24:
  • Proportion of subjects with IGA PN‑S 0 or 1 (the equivalent of 0 to 5 nodules)
  • Proportion of subjects who achieved both ≥4-point improvement in WI‑NRS and IGA PN‑S of 0 or 1 at Week 24
  • Proportion of subjects with ≥4‑point improvement in WI‑NRS (PRIME2 only)

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.

Discover ITCH IMPROVEMENT DATA

EXPLORE WI-NRS RESULTS

Dosage and administration

Thinking about prescribing DUPIXENT? Find the
information you need to get started.

View administration Options