CUPID A and C: Dupilumab Improves Quality of Life in Omalizumab-Naive CSU

New findings suggest dupilumab (Dupixent) improved disease-specific quality of life at the 24-week mark compared with placebo in omalizumab-naive individuals living with chronic spontaneous urticaria (CSU) inadequately controlled with H1 antihistamines, according to a post hoc pooled analysis of the phase 3 LIBERTY-CSU CUPID Study A and Study C trials.¹

This analysis and its conclusions were presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.¹ Earlier CUPID results showed reductions in itch and hives with dupilumab in this population. The new analysis shifts focus to patient-reported burden, using the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), the only validated disease-specific health-related quality of life (HRQoL) instrument for chronic urticaria. Thomas B. Casale, of the University of South Florida, served as first author, with coauthors from academic centers in the US, Germany, Japan, and Spain, as well as Sanofi and Regeneron.¹

How Did Dupilumab Affect Quality of Life in the CUPID Trials?

Investigators pooled intent-to-treat data from CUPID Study A and Study C (NCT04180488).¹˒² The CU-Q2oL comprises 23 self-rated items with a 2-week recall period, producing an overall score from 0 - 100 and 6 domain scores, with higher values reflecting greater impairment. Week 24 changes from baseline were compared using an analysis of covariance model adjusted for baseline value, study, treatment group, baseline angioedema, and region.¹

The pooled population included 289 patients, with 144 receiving dupilumab and 145 receiving placebo. Mean baseline overall score was 41.1 (SD, 20.2), with balanced arms. Itch and hives carried the heaviest baseline burden, as 74.7% and 67.0% of patients, respectively, reported being very much or extremely bothered.¹

At week 24, dupilumab reduced the overall CU-Q2oL score versus placebo (least squares [LS] mean difference, −5.27; 95% CI, −9.33 to −1.20; P = .0111). Domain improvements reached nominal significance for pruritus (−12.78; 95% CI, −19.61 to −5.95; P = .0002), limits (−5.18; 95% CI, −9.52 to −0.83; P = .0196), and looks (−5.29; 95% CI, −9.62 to −0.96; P = .0166).¹

Sleep problems (−5.07; P = .0529), swelling (−3.09; P = .0849), and impact on life activities (−3.93; P = .1042) trended in favor of dupilumab without reaching nominal significance.¹

Did Dupilumab Help Patients Report No Itch, Hives, or Swelling?

Investigators also compared the proportion of patients reporting the best possible outcome using a Cochran-Mantel-Haenszel test, adjusted for baseline severity, angioedema, study, and region.¹

A larger share of dupilumab-treated patients selected the most favorable response, "not at all," in the pruritus domain, which covers itch and hives (24.3% vs 11.0%; odds ratio [OR], 3.05; 95% CI, 1.53-6.10; P = .0012). The swelling domain, covering eye and lip swelling, showed a similar pattern (74.3% vs 60.0%; OR, 2.21; 95% CI, 1.24-3.94; P = .0061).¹

Across individual items, dupilumab outperformed placebo on 22 of 23, with work as the lone exception (P = .0555).¹

The investigators wrote the pruritus finding aligns with the phase 3 primary data, while the swelling result suggests an effect on angioedema. They concluded dupilumab addresses both the physical symptoms and the psychosocial dimensions of CSU. Gains in the limits and looks domains suggest benefits extending into daily functioning and self-image.¹

What Are the Limitations of This Analysis?

The analysis was post hoc, and all reported P values were described as nominal. Results apply only to omalizumab-naive patients inadequately controlled with H1 antihistamines.¹

In their release, the investigators highlighted the abstract did not report safety or adverse event outcomes for the pooled population. Durability of the quality of life gains beyond the 24-week mark was noted as also outside the scope of the analysis.

Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

References

1. Casale TB, Bernstein JA, Metz M, et al. Dupilumab improves disease-specific quality of life in omalizumab-naïve patients with chronic spontaneous urticaria: a post-hoc pooled analysis from the LIBERTY-CSU CUPID A and C phase 3 trials. Abstract AS-3302. Presented at: 2026 European Academy of Dermatology and Venereology Congress; 2026; Vienna, Austria.

2. Dupilumab for chronic spontaneous urticaria (LIBERTY-CSU CUPID). ClinicalTrials.gov identifier: NCT04180488. Accessed September 29, 2026. https://clinicaltrials.gov/study/NCT04180488.