Significant itch results demonstrated in 3 pivotal trials2
CHRONOS: Concomitant Therapy With TCS
Significant itch reduction was also demonstrated with DUPIXENT in monotherapy trials
(secondary endpoint)2,4,a,b
41
%
of adults treated with DUPIXENT (n=213) achieved ≥4-point reduction in
Peak Pruritus NRS vs 12% with placebo at
Week 16 in
SOLO 1 (n=212; P<0.001)
36
%
of adults treated with DUPIXENT (n=225) achieved ≥4-point reduction in
Peak Pruritus NRS vs 10% with placebo at
Week 16 in
SOLO 2 (n=221; P<0.001)
Change in daily Peak Pruritus NRS with DUPIXENT in monotherapy trials in a post hoc analysis of SOLO 1 and SOLO 25
SOLO 1 and SOLO 2 (pooled): DUPIXENT Monotherapy
Limitations of analysis:
- The prespecified itch endpoint in SOLO 1 and SOLO 2 used weekly averaged Peak Pruritus NRS; this post
hoc
analysis is based on daily
Peak Pruritus NRS5 - Definitive conclusions cannot be made as this daily Peak Pruritus analysis (compared with weekly
averaged analysis) was post hoc
and was not statistically powered in these trials5
LSM, least squares mean.
aIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.
bFull Analysis Set includes all subjects randomized.
cIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.
dWeek 52 data were limited to patients completing 52 weeks as of the cutoff date.
eP<0.0001 vs placebo.
Pruritus NRS assesses the average itch intensity over the previous 24 hours6
It is a patient-reported measure that uses a 0- to 10-point scale, with which patients are asked:
“On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?”
None
The Worst
Imaginable
Administration