Skip to main content

TWO PIVOTAL TRIALSa OF BIOLOGIC-NAIVEb PATIENTS 12+ YEARS OF
AGEc WITH CHRONIC SPONTANEOUS URTICARIA (CSU)

  CUPID-A CUPID-C
Study endpoints at
Week 241,2		 DUPIXENT
(n=68)		 Placebo
(n=68)		 DUPIXENT
(n=73)		 Placebo
(n=75
PRIMARY ENDPOINT
ISS7: itch severity score over 7 days (change from baseline)
64% 35%
(-10.44 change from baseline vs -6.02,
respectively; P=0.0003)
48% 33%
(-8.50 change from baseline vs -6.13,
respectively; P=0.0270)
Mean at baseline 16.25 15.74 15.18 14.96
SECONDARY ENDPOINTS
HSS7: hives severity score over 7
days (change from baseline)
68% 36%
(-10.54 change from baseline vs
-5.85, respectively; P=0.0001)
46% 31%
(-7.16 change from baseline vs
-5.15, respectively; P=0.0450)
Mean at baseline 15.85 15.03 13.31 12.90
UAS7: urticaria activity score over 7 days (change from baseline)
66% 36%
(-20.99 change from baseline vs
-11.95, respectively; P=0.0001)
48% 32%
(-15.61 change from baseline vs
-11.27, respectively: P=0.0324)
Mean at baseline 32.10 30.76 28.48 27.86
UAS7=0 (proportion of patients who were urticaria-free) 32%
(P=0.0133)		 13% 30%
(P=0.0133)		 17%
UAS7 ≤ 6 (proportion of patients with well-controlled disease) 47%
(P=0.0034)		 24% 40%
(P=0.0034)		 23%

Study endpoints at Week 241,2

CUPID-A
DUPIXENT
(n=68)		 Placebo
(n=68)
PRIMARY ENDPOINT
ISS7: itch severity score over 7 days (change from baseline)
64% 35%
(-10.44 change from baseline vs -6.02, respectively; P=0.0003)
Mean at baseline
16.25 15.74
SECONDARY ENDPOINTS
HSS7: hives severity score over 7 days (change from baseline)
68% 36%
(-10.54 change from baseline vs -5.85, respectively; P=0.0003)
Mean at baseline
15.85 15.03
UAS7: urticaria activity score over 7 days (change from baseline)
66% 36%
(-20.99 change from baseline vs -11.95, respectively; P=0.0003)
Mean at baseline
32.10 30.76
UAS7=0 (proportion of patients who were urticaria-free)
32%
(P=0.0133)		 13%
UAS7≤6 (proportion of patients with well-controlled disease)
47%
(P=0.0034)		 24%
CUPID-C
DUPIXENT
(n=73)		 Placebo
(n=75)
PRIMARY ENDPOINT
ISS7: itch severity score over 7 days (change from baseline)
48% 33%
(-8.50 change from baseline vs -6.13, respectively; P=0.0270)
Mean at baseline
15.18 14.96
SECONDARY ENDPOINTS
HSS7: hives severity score over 7 days (change from baseline)
46% 31%
(-7.16 change from baseline vs - 5,15, respectively; P=0.0450)
Mean at baseline
13.31 12.90
UAS7: urticaria activity score over 7 days (change from baseline)
48% 32%
(-20.99 change from baseline vs -11.95, respectively; P=0.0003)
Mean at baseline
28.84 27.86
UAS7=0 (proportion of patients who were urticaria-free)
30%
(P=0.0133)		 17%
UAS7≤6 (proportion of patients with well-controlled disease)
40%
(P=0.0034)		 23%

aCUPID-A and CUPID-C were 24-week randomized, double-blind, placebo-controlled trials in adults and adolescents (aged 12-17 years) with CSU who remained symptomatic despite treatment with H1 antihistamines. Participants had been diagnosed with CSU at least 6 months prior to screening (mean disease duration of 6.2 years). Disease activity at baseline was defined by ISS7 ≥8 (on a scale of 0 to 21) and UAS7 ≥16 (on a scale of 0 to 42). Patients with active atopic dermatitis were excluded from the trial. At baseline, mean ISS7 was 16.0 in CUPID-A and 15.1 in CUPID-C; mean HSS7 (on a scale of 0 to 21) was 15.4 in CUPID-A and 13.1 in CUPID-C; mean UAS7 was 31.4 in CUPID-A and 28.2 in CUPID-C.1

bBiologic-naive defined as no anti-lgE treatment.1

cStudy population in CUPID-A included 132 adults and 4 adolescents; study population in CUPID-C included 142 adults and 6 adolescents. All DUPIXENT-treated adults and adolescents ≥60 kg received a subcutaneous dose of DUPIXENT 600 mg on Day 1, followed by 300 mg Q2W and adolescents 30 kg to <60 kg received a subcutaneous dose of DUPIXENT 400 mg on Day 1, followed by 200 mg Q2W. All participants remained on background therapy of H1 antihistamines.1,2

See the efficacy across key measures
VIEW ISS7
RESULTS
VIEW HSS7
RESULTS
VIEW UAS7
RESULTS
UAS7 RESPONDER
ANALYSES

CUPID-A and CUPID-C assessed the efficacy of DUPIXENT for itch relief (ISS7), hive reduction (HSS7), and urticaria activity score over 7 days (UAS7) at Week 24.

The severity of itch is measured by a patient-reported itch severity score (ISS, ranging from 0 = none to 3 = intense). The ISS7 score is the sum of daily ISS scores measured by a patient at the same time each day over 7 days, with an overall scale of 0 to 212:

0 None
None
1 Mild
Present but not annoying or troublesome
2 Moderate
Troublesome but does not interfere with normal daily activity or sleep
3 Intense
Interferes with normal daily activity or sleep

The severity of hives is measured by a patient-reported hives severity score (HSS, ranging from 0 = none to 3 = more than 50 hives). The HSS7 score is the sum of daily HSS scores measured by a patient at the same time each day over 7 days, with an overall scale of 0 to 212:

0
None
1
<20 hives
2
20 to 50 hives
3
>50 hives

Urticaria activity score (UAS) is a composite patient-reported outcome measure, which is the sum of the daily itch severity score (ISS, ranging from 0 = none to 3 = intense) and daily hive severity score (HSS, ranging from 0 = none to 3 = more than 50 hives). UAS7 is the sum of the preceding 7 days’ itch and hives scores, for a total UAS7 range of 0 to 42. Urticaria disease activity is classified in 5 severity categories2:

ISS7

0
1-7
8-14
15-21

+

HSS7

0
1-7
8-14
15-21

=

UAS7

0 Urticaria-free
1-6 Well controlled
7-15 Mild
16-27 Moderate
28-42 Severe
DEMONSTRATED SAFETY PROFILE
ADVERSE REACTIONS OCCURRING IN ≥2%
OF PATIENTS THROUGH WEEK 241
POOLED ACROSS CUPID STUDIES A, B, AND Cd
ADVERSE REACTION DUPIXENT
200/300 mg
Q2W (n=195)
%		 Placebo
(n=197)
%
Injection site reactione 10 8
Rate of treatment discontinuation at Week 242,d
Rate of discontinuations due to adverse events vs placebo
1.0%

DUPIXENT

VS
2.5%

PLACEBO

  • Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment1

Q2W, every 2 weeks.

dPooled safety population from CUPID-A, CUPID-B, and CUPID-C. CUPID-B was an identically designed study that enrolled 108 CSU patients (aged 12 years or older) who were inadequate responders (N=104) to H1 antihistamines and anti-IgE treatments or intolerant (N=4) to anti-IgE therapy. The efficacy of DUPIXENT was based only on CUPID-A and CUPID-C; CUPID-B did not meet the primary endpoint.

eInjection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, and injection site swelling.

DOSAGE AND ADMINISTRATION

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

Explore Administration Options