CLINICAL TRIAL DESIGNS AND TRIAL RESULTS IN BIOLOGIC-NAIVEa PATIENTS
Trial Designs: 284 adults and adolescents (12-17 years) with CSU who remained symptomatic despite H1 AH treatment were randomized in CUPID‑A and CUPID‑C to DUPIXENT or placebo. All participants were anti-IgE treatment naive and remained on a stable H1 AH dose. DUPIXENT‐treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose, and adolescents 30 to <60 kg received 200 mg Q2W after a 400 mg loading dose. At baseline, mean ISS7 (on a scale of 0 to 21) for CUPID-A was 16.0 and for CUPID-C was 15.1; mean HSS7 (on a scale of 0 to 21) for CUPID-A was 15.4 and for CUPID-C was 13.1; and mean UAS7 (on a scale of 0 to 42) for CUPID-A was 31.4 and for CUPID-C was 28.2.1,2
Trial Results: The primary endpoint was change from baseline in ISS7 at Week 24 (-10.44 with DUPIXENT vs -6.02 with placebo in CUPID-A, P=0.0003; -8.50 with DUPIXENT vs -6.13 with placebo in CUPID-C, P=0.0270). Other endpoints included change from baseline in HSS7 at Week 24 (-10.54 with DUPIXENT vs -5.85 with placebo in CUPID-A, P=0.0001; -7.16 with DUPIXENT vs -5.15 with placebo in CUPID-C, P=0.0450), change from baseline in UAS7 at Week 24 (key secondary endpoint: -20.99 with DUPIXENT vs -11.95 with placebo in CUPID-A, P=0.0001; -15.61 with DUPIXENT vs -11.27 with placebo in CUPID-C, P=0.0324), and proportion of participants who achieved UAS7=0 (urticaria-free) at Week 24 (32% of patients treated with DUPIXENT vs 13% with placebo in CUPID-A, P=0.0133; and 30% vs 17%, respectively, in CUPID-C, P=0.0165).1,2
The most common adverse reactions (incidence ≥2%) in patients with CSU were injection site reactions.1,b
Trial Efficacy Measures: Itch severity score (ISS) and hives severity score (HSS) are patient-reported assessments rated on a scale of 0 (none), 1 (mild itch/<20 hives), 2 (moderate itch/20 to 50 hives), and 3 (intense itch/>50 hives). ISS7 is the sum of the preceding 7 days’ itch scores, for a total ISS7 range of 0 to 21. HSS7 is the sum of the preceding 7 days’ hives scores, for a total HSS7 range of 0 to 21. Urticaria activity score (UAS) is the composite of ISS and HSS. UAS7 is the sum of ISS7 and HSS7 scores, for a total UAS7 range of 0 to 42.1,2
- aBiologic-naive defined as no anti-IgE treatment.
- bInjection 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.

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Sadie Age 26Battling Unpredictable Flares
Sadie,
Age 26
Battling Unpredictable Flares
Whether home or abroad, I never knew when the hives would strike. The itch could be unbearable. DUPIXENT
provided the relief I was looking for.
— SadieCASE HISTORY
- Experienced first flare in her early
twenties with reoccurring episodes of itch
and widespread hives - No allergic or environmental triggers
could be identified - Itch and hives persisted through multiple
urgent care and primary care visits over
the past year - Tried different therapies, from home
remedies to antihistamines and oral
corticosteroids, but the itching and hives
would still randomly appear
TREATMENT BEFORE DUPIXENT
- Impacted by unpredictable bouts of hives
and itch - Prescribed H1 antihistamines, but
breakthrough flares would occur
despite updosing - Sadie was referred to a dermatologist and
was diagnosed with CSU. She inquired
about allergy testing, but her dermatologist
explained that it was not required because
CSU is not an allergic condition
EXPERIENCE WITH DUPIXENT
- After discussing the efficacy and
safety of DUPIXENT, Sadie and her
doctor decided to start treatment - Both her itch and hives began to reduce
over time - At Sadie's 24-week follow-up visit, her
CSU was under control, with fewer hives
and less itch
- Experienced first flare in her early
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Noah Age 35Struggling With Itch and Hive Cycles
Noah,
Age 35
Stuggling With Itch and Hive Cycles
The itching and hives were unrelenting. I'd be dealing with it even when I was at work. My doctor helped me finally get answers and DUPIXENT helped bring me relief.
— NoahCASE HISTORY
- First flare appeared in his mid-thirties out
of nowhere, with persistent hives and
intermittent angioedema for several months - Disruptive itch and recurring hives
appeared randomly, at home, at work,
wherever he was - He looked for allergy triggers but found none
- Started at urgent care and was seeking
answers, which included inquiring about
allergy testing
TREATMENT BEFORE DUPIXENT
- Upon review of Noah's disease history and
photos, he was diagnosed with CSU - Flares were still unpredictable; he
never knew when they would appear - Itch and hives persisted even after H1
antihistamines were prescribed and updosed - He wanted something to help relieve his
symptoms that he could take at home
after proper training, without having to
take the initial doses at the doctor's office
EXPERIENCE WITH DUPIXENT
- After discussing all systemic
treatment options available, Noah and
his doctor decided on DUPIXENT - He reported experiencing fewer hives with
less itch at his 24-week follow-up
- First flare appeared in his mid-thirties out
CSU, chronic spontaneous urticaria; Q2W, once every 2 weeks.
PATIENTS WITH CSU
MAY REQUIRE
TREATMENT BEYOND H1 ANTIHISTAMINES
Make DUPIXENT your first
choice.