Dupilumab Improved Itch and Urticaria Activity Across Subgroups in Chronic Spontaneous Urticaria

Dupilumab reduced itch severity and urticaria activity at 24 weeks compared with placebo across multiple patient subpopulations with chronic spontaneous urticaria (CSU), according to pooled analyses from the phase 3 LIBERTY-CSU CUPID Study A and Study C (NCT04180488).¹

Investigators evaluated whether baseline demographic and disease characteristics—including body mass index (BMI), angioedema status, and gender—affected treatment response in omalizumab-naive patients with CSU. In the pooled population, 144 patients received dupilumab and 145 received placebo. The mean age was 43.2 years in the dupilumab group and 43.0 years in the placebo group. Female patients comprised 61.1% and 75.2% of the dupilumab and placebo groups, respectively, and 54.9% and 59.3% were White.¹

The primary efficacy assessments for this analysis were least squares (LS) mean change from baseline at week 24 in the 7-day Itch Severity Score (ISS7) and the 7-day Urticaria Activity Score (UAS7).¹

Across BMI subgroups, dupilumab demonstrated greater reductions in ISS7 compared with placebo at week 24. Among patients with BMI <25 kg/m², LS mean change was –10.4 with dupilumab versus –6.3 with placebo. In patients with BMI ≥25 to <30 kg/m², changes were –9.0 versus –6.7, respectively. In those with BMI ≥30 kg/m², reductions were –10.2 with dupilumab compared with –6.6 with placebo.¹

Similarly, ISS7 improvements were observed irrespective of angioedema status. In patients with baseline angioedema, LS mean change was –8.8 with dupilumab versus –6.1 with placebo. Among patients without angioedema, reductions were –11.2 versus –7.5, respectively. By gender, male patients experienced a –10.9 reduction with dupilumab versus –7.9 with placebo, and female patients had reductions of –9.6 versus –6.3, respectively.¹

Consistent findings were reported for UAS7 at week 24. In the BMI <25 kg/m² subgroup, LS mean change was –19.6 with dupilumab versus –11.7 with placebo. Among patients with BMI ≥25 to <30 kg/m², reductions were –18.1 versus –14.0, and in those with BMI ≥30 kg/m², –20.4 versus –13.3, respectively.¹

In patients with angioedema at baseline, UAS7 decreased by –17.9 with dupilumab compared with –12.6 with placebo. In those without angioedema, reductions were –21.0 versus –14.2, respectively. By gender, UAS7 decreased by –19.8 in male patients receiving dupilumab versus –14.7 with placebo, and –19.1 versus –12.5, respectively, in women.¹

Safety findings were generally consistent with the known safety profile of dupilumab.¹

The authors concluded that dupilumab consistently reduced itch severity and urticaria activity at week 24 across subpopulations defined by baseline BMI, angioedema status, and gender in omalizumab-naive patients with CSU.¹

The findings come after the US FDA approval of dupilumab for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis, the first approval for AFRS.²

Reference:

1. Casale T, Saini S, Gimenez-Arnau A, et al. Dupilumab Reduced Itch And Urticaria Activity In Chronic Spontaneous Urticaria Patient Subpopulations. J Allergy Clin Immunol. 2026;157:AB1.
2. FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis. News release. US Food and Drug Administration. February 25, 2026. Accessed February 27, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-adult-and-pediatric-patients-aged-6-and-older-allergic-fungal-rhinosinusitis