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Disease control demonstrated in biologic-naivea patients in 2 pivotal trialsb

Significant reduction in itch, hives, and disease control at Week 24 in patients 12+ years of age1,2,c

  CUPID-A CUPID-C
  DUPIXENT
(n=68)		 Placebo
(n=68)		 DUPIXENT
(n=73)		 Placebo
(n=75)
ITCH REDUCTION
Primary endpoint: ISS7, itch severity score over 7 days (change from baseline)
64% 35%
(-10.44 change from baseline vs -6.02; P=0.0003)
Mean at baseline was 16.25 and 15.74, respectively.
48% 33%
(-8.50 change from baseline vs -6.13; P=0.0270)
Mean at baseline was 15.18 and 14.96, respectively.
REDUCTION IN HIVES
Secondary endpoint: HSS7, hives severity score over 7 days (change from baseline)
68% 36%
(-10.54 change from baseline vs -5.85; P=0.0001)
Mean at baseline was 15.85 and 15.03, respectively.
46% 31%
(-7.16 change from baseline vs -5.15; P=0.0450)
Mean at baseline was 13.31 and 12.90, respectively.
REDUCTION IN ITCH AND HIVES
Secondary endpoint: UAS7, urticaria activity score over 7 days (change from baseline)
66% 36%
(-20.99 change from baseline vs -11.95; P=0.0001)
Mean at baseline was 32.10 and 30.76, respectively.
48% 32%
(-15.61 change from baseline vs -11.27; P=0.0324)
Mean at baseline was 28.48 and 27.86, respectively.
DISEASE CONTROL
Secondary endpoint: UAS7=0 (proportion of patients who were urticaria-free) 32%
(P=0.0133)		 13% 30%
(P=0.0165)		 17%
Secondary endpoint: UAS7 ≤6 (proportion of patients with well-controlled disease) 47%
(P=0.0034)		 24% 40%
(P=0.0062)		 23%
CUPID-A
ITCH REDUCTION
Primary endpoint: ISS7, itch severity score over 7
days (change from baseline)
DUPIXENT
(n=68)		 64%
Placebo
(n=68)		 35%
(-10.44 change from baseline vs -6.02; P=0.0003)
Mean at baseline was 16.25 and 15.74,
respectively.
REDUCTION IN HIVES
Secondary endpoint: HSS7, hives severity score
over 7 days (change from baseline)
DUPIXENT
(n=68)		 68%
Placebo
(n=68)		 36%
(-10.54 change from baseline vs -5.85; P=0.0001)
Mean at baseline was 15.85 and 15.03,
respectively.
REDUCTION IN ITCH AND HIVES
Secondary endpoint: UAS7, urticaria activity
score over 7 days (change from baseline)
DUPIXENT
(n=68)		 66%
Placebo
(n=68)		 36%
(-20.99 change from baseline vs -11.95; P=0.0001)
Mean at baseline was 32.10 and 30.76,
respectively.
DISEASE CONTROL
Secondary endpoint: UAS7=0 (proportion of
patients who were urticaria-free)
DUPIXENT
(n=68)		 32%
(P=0.0133)
Placebo
(n=68)		 13%
Secondary endpoint: UAS7 ≤6 (proportion of
patients with well-controlled disease)
DUPIXENT
(n=68)		 47%
(P=0.0034)
Placebo
(n=68)		 24%
CUPID-C
ITCH REDUCTION
Primary endpoint: ISS7, itch severity score over 7
days (change from baseline)
DUPIXENT
(n=73)		 48%
Placebo
(n=75)		 33%
(-8.50 change from baseline vs -6.13; P=0.0270)
Mean at baseline was 15.18 and 14.96,
respectively.
REDUCTION IN HIVES
Secondary endpoint: HSS7, hives severity score
over 7 days (change from baseline)
DUPIXENT
(n=73)		 46%
Placebo
(n=75)		 31%
(-7.16 change from baseline vs -5.15; P=0.0450)
Mean at baseline was 13.31 and 12.90,
respectively.
REDUCTION IN ITCH AND HIVES
Secondary endpoint: UAS7, urticaria activity
score over 7 days (change from baseline)
DUPIXENT
(n=73)		 48%
Placebo
(n=75)		 32%
(-15.61 change from baseline vs -11.27; P=0.0324)
Mean at baseline was 28.48 and 27.86,
respectively.
DISEASE CONTROL
Secondary endpoint: UAS7=0 (proportion of
patients who were urticaria-free)
DUPIXENT
(n=73)		 30%
(P=0.0165)
Placebo
(n=75)		 17%
Secondary endpoint: UAS7 ≤6 (proportion of
patients with well-controlled disease)
DUPIXENT
(n=73)		 40%
(P=0.0062)
Placebo
(n=75)		 23%

Use of DUPIXENT for the CSU indication in patients aged 2-11 years is supported by evidence from two studies of DUPIXENT in CSU patients 12+ years of age.1

aBiologic-naive defined as no anti-IgE treatment.1

bCUPID-A and CUPID-C were 24-week randomized, double-blind, placebo-controlled trials in adults and adolescents (12+ 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.1,2

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 efficacy across key measures

VIEW ISS7 RESULTS VIEW HSS7 RESULTS VIEW HSS7 RESULTS UAS7 RESPONDER ANALYSES

Demonstrated safety profile1

Most common adverse reactions (incidence ≥2%) in patients with chronic spontaneous urticaria are injection site reactionsa

  • The safety of DUPIXENT was assessed in 18 subjects 2-11 years of age who received DUPIXENT based on weight. No new adverse reactions were identified in pediatric subjects aged 2-11 years who received DUPIXENT
SAFETY DATA

aInjection 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, injection site swelling.

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CSU, chronic spontaneous urticaria; Q2W, once every 2 weeks.