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TWO PIVOTAL TRIALS OF BIOLOGIC-NAIVEa PATIENTS 12+ YEARS OF
AGE WITH CHRONIC SPONTANEOUS URTICARIA (CSU)

  CUPID-A1,2 CUPID-C1,2
CUPID-A and CUPID-C
assessed the efficacy of
DUPIXENT on itch relief and
hive reduction at Week 24.1,2
DUPIXENT 
(n=68)
Placebo 
(n=68)
DUPIXENT 
(n=73)
Placebo 
(n=75)
Primary endpoint
Reduction from baseline in itch
severity score over 7 days (ISS7)
64%
-10.44
(P=0.0003)
35%
-6.02
48%
-8.50
(P=0.0270)
33%
-6.13
Mean at baseline 16.25 15.74 15.18 14.96
Key secondary endpoint
Reduction from baseline in
urticaria activity score over
7 days (UAS7)
66%
-20.99
(P=0.0001)
36%
-11.95
48%
-15.61
(P=0.0324)
32%
-11.27
Mean at baseline 32.10 30.76 28.48 27.86
Other secondary endpoints
Reduction from baseline in
hives severity score over
7 days (HSS7)
68%
-10.54
(P=0.0001)
36%
-5.85
46%
-7.16
(P=0.0450)
31%
-5.15
Mean at baseline 15.85 15.03 13.31 12.90
Proportion of patients with
complete response (UAS7=0)
32%
(P=0.0133)
13% 30%
(P=0.0165)
17%
Proportion of patients with
well-controlled symptoms
(UAS7 ≤6)
47%
(P=0.0034)
24% 40%
(P=0.0062)
23%

CUPID-A and CUPID-C assessed the
efficacy of DUPIXENT on itch relief
and hive reduction at Week 24.1,2

CUPID-A1,2
DUPIXENT 
(n=68)
Placebo 
(n=68)
Primary endpoint
Reduction from baseline in itch severity
score over 7 days (ISS7)
64%
-10.44
(P=0.0003)
35%
-6.02
Mean at baseline
16.25 15.74
Key secondary endpoint
Reduction from baseline in urticaria activity
score over 7 days (UAS7)
66%
-20.99
(P=0.0001)
36%
-11.95
Mean at baseline
32.10 30.76
Other secondary endpoints
Reduction from baseline in hives severity
score over 7 days (HSS7)
68%
-10.54
(P=0.0001)
36%
-5.85
Mean at baseline
15.85 15.03
Proportion of patients with
complete response (UAS7=0)
32%
(P=0.0133)
13%
Proportion of patients with
well-controlled symptoms (UAS7 ≤6)
47%
(P=0.0034)
24%
CUPID-C1,2
DUPIXENT 
(n=73)
Placebo 
(n=75)
Primary endpoint
Reduction from baseline in itch severity
score over 7 days (ISS7)
48%
-8.50
(P=0.0270)
33%
-6.13
Mean at baseline
15.18 14.96
Key secondary endpoint
Reduction from baseline in urticaria activity
score over 7 days (UAS7)
48%
-15.61
(P=0.0324)
32%
-11.27
Mean at baseline
28.48 27.86
Other secondary endpoints
Reduction from baseline in hives severity
score over 7 days (HSS7)
46%
-7.16
(P=0.0450)
31%
-5.15
Mean at baseline
13.31 12.90
Proportion of patients with
complete response (UAS7=0)
30%
(P=0.0165)
17%
Proportion of patients with
well-controlled symptoms (UAS7 ≤6)
40%
(P=0.0062)
23%

aBiologic-naive defined as no anti-IgE treatment.

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 Cb
ADVERSE REACTION DUPIXENT
200/300 mg
Q2W (n=195)
%
Placebo
(n=197)
%
Injection site reactionc 10 8
Rate of treatment discontinuation at Week 241,b
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.

bPooled 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.

cInjection 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.