IDENTIFY POTENTIAL CSU PATIENTS WHO REMAIN SYMPTOMATIC DESPITE TREATMENT WITH H1 ANTIHISTAMINES (H1 AH)

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.