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

57% of patients did not have a history of atopy (defined as having a medical history of atopic dermatitis, allergic rhinitis/rhinoconjunctivitis, asthma, or 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; WI-NRS, Worst Itch numerical rating scale.

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EXPLORE WI-NRS RESULTS

Dosage and administration

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