CLINICAL TRIAL RESULTS AND TRIAL DESIGNS

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.

Jennifer

Age 42

Living with PN

Currently taking DUPIXENT

I felt extremely itchy, and the
nodules were always there. I
tried topicals and even steroid
injections. With DUPIXENT, I
have it under control.

Real patient being treated with DUPIXENT.
Individual results may vary.
Real patient being treated with DUPIXENT.
Individual results may vary.

My story

When I first saw red dots on my
thighs, I
went to the doctor. I tried
over-the-counter
and prescription
topical options, but the
signs and
symptoms continued to get worse.
I saw different doctors, who ran
tests that
were inconclusive. I
tried many
unsuccessful
treatments. After years of
itching
and bleeding nodules, a
dermatologist diagnosed me with
PN. Then,
DUPIXENT was
approved for PN, and I was
finally
able to gain control of my disease. 

My signs and symptoms

  • Red dots on my thighs
    eventually
    progressed to
    nodules all over my legs and
    arms
  • The itching was persistent and
    extremely uncomfortable
  • Nodules and itching were a
    constant in my life

My treatment and goals

  • Steroids provided only short-
    term relief, whether topical,
    oral, or injected into the
    nodules
  • I needed a treatment to help
    treat the intense itch and
    nodules