TRIAL DESIGN AND ENDPOINTS
The prurigo nodularis (PN) development program included two 24-week randomized, double-blind, placebo-controlled, multicenter, parallel-group trials (PRIME and PRIME2) in 311 adult subjects 18 years of age and older with pruritus (WI-NRS ≥7 on a scale of 0 to 10) and greater than or equal to 20 nodular lesions. PRIME and PRIME2 assessed the effect of DUPIXENT on pruritus improvement as well as its effect on PN lesions. In these two trials, subjects received either subcutaneous DUPIXENT 600 mg (two 300 mg injections) on Day 1, followed by 300 mg Q2W for 24 weeks, or matching placebo.1,2
The WI-NRS is comprised of a single item, rated on a scale from 0 (“no itch”) to 10 (“worst imaginable itch”). Subjects were asked to rate the intensity of their worst pruritus (itch) over the past 24 hours using this scale. The IGA PN-S measures the approximate number of nodules using a 5-point scale from 0 (clear) to 4 (severe). The primary efficacy endpoints were the proportion of subjects with improvement (reduction) in WI-NRS by ≥4 points at Week 24 in PRIME, and Week 12 in PRIME2. Key secondary endpoints included the proportion of subjects with improvement (reduction) in WI-NRS by ≥4 points at Week 24 in PRIME2, and the proportion of subjects with IGA PN-S 0 or 1 (the equivalent of 0-5 nodules) in both trials.1,2
IGA PN-S, Investigator's Global Assessment PN-Stage; Q2W, once every 2 weeks; WI-NRS, Worst Itch Numeric Rating Scale.
Joseph, 54, has lived
with prurigo nodularis
for 10 years
Struggling with topicals
I've picked and scratched at the
persistent itch and unsightly
nodules for 10+ years. Now
with
DUPIXENT, I have it under
control.
—Joseph
Not an actual
DUPIXENT patient.
Story is inspired
by people who
have
prurigo
nodularis.
Signs and symptoms
- Between 50 to 70 nodules on trunk and arms
-
Intense itch-scratch cycle that resulted in nodules and
scarring - Bothersome itch, even where nodules were not present
Treatment and goals
- Previous management approaches have been unsuccessful
-
A therapy to help improve his itch and reduce nodules
is needed
Sofia, 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.
—Sofia
Not an actual
DUPIXENT patient.
Story is inspired
by people who
have
prurigo
nodularis.
Signs and symptoms
- Around 50 nodules on her back and extremities
- Intense itching and scratching
- Itch present even where nodules were not active
Treatment and goals
- Previous management approaches have been unsuccessful
- A therapy to help improve her itch and heal her skin nodules is needed