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Introduction <p>Chronic spontaneous urticaria (CSU) is characterized by itchy hives with or without angioedema recurring for &gt; 6&#xa0;weeks. Many patients experience a substantial disease burden despite H1-antihistamine treatment, including impaired health-related quality of life (HRQoL). In the current analysis, we evaluated the efficacy of dupilumab in improving HRQoL in omalizumab-naïve patients with CSU.</p> Methods <p>LIBERTY-CSU CUPID Study A was a double-blind, phase 3 trial that evaluated the efficacy and safety of dupilumab in patients aged ≥ 6&#xa0;years with CSU who remained symptomatic despite H1-antihistamine treatment. Patients were randomized to receive dupilumab 300&#xa0;mg every 2&#xa0;weeks (q2w; <i>n</i> = 70) or placebo q2w (<i>n</i> = 68). The current analysis evaluated the change from baseline to week 12 and week 24 in the total scores of the Dermatology Life Quality Index (DLQI), Chronic Urticaria Quality of Life Questionnaire (CU-Q<sub>2</sub>oL), and EuroQol (EQ)-Visual Analog Scale (VAS). Additional outcomes included changes from baseline to week 12 and week 24 in DLQI severity categories and the proportion of patients reporting “not at all/a little” effect on individual items of DLQI and CU-Q<sub>2</sub>oL questionnaires.</p> Results <p>At week 24, dupilumab significantly improved total DLQI and CU-Q<sub>2</sub>oL scores compared with placebo {difference: −3.2 (95% confidence interval [CI] −5.2 to −1.1; nominal <i>p</i> = 0.0026) and −8.6 (95% CI −14.6 to −2.6; nominal <i>p</i> = 0.0049), respectively}, as well as EQ-VAS score (difference: 6.0 [95% CI 0.9 to 11.2; nominal <i>p</i> = 0.0210]). Similar trends were observed for week 12. Significantly more dupilumab versus placebo recipients reported “no or little” effect for most of the DLQI and CU-Q<sub>2</sub>oL items (nominal <i>p</i> &lt; 0.05).</p> Conclusions <p>Dupilumab significantly improved HRQoL in omalizumab-naïve patients with CSU who remained symptomatic despite standard-of-care H1-antihistamine treatment. Quality-of-life improvement with dupilumab addresses an important goal of CSU treatment.</p> Clinical Trial Registration <p>ClinicalTrials.gov identifier: NCT04180488.</p>

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Dupilumab Improves Health-Related Quality of Life in Omalizumab-Naïve Patients with Chronic Spontaneous Urticaria

  • 期刊论文

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  • 发表日期：

    2025年12月2日

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  • Ana M. Giménez-Arnau,
  • Thomas B. Casale,
  • Gil Yosipovitch,
  • Luis Felipe Ensina,
  • Naoko Inomata,
  • Jérôme Msihid,
  • Melanie Makhija,
  • Allen Radin,
  • Sonya L. Cyr,
  • Philip Sugerman,
  • Ryan B. Thomas,
  • Chien-Chia Chuang

摘要

Introduction

Chronic spontaneous urticaria (CSU) is characterized by itchy hives with or without angioedema recurring for > 6 weeks. Many patients experience a substantial disease burden despite H1-antihistamine treatment, including impaired health-related quality of life (HRQoL). In the current analysis, we evaluated the efficacy of dupilumab in improving HRQoL in omalizumab-naïve patients with CSU.

Methods

LIBERTY-CSU CUPID Study A was a double-blind, phase 3 trial that evaluated the efficacy and safety of dupilumab in patients aged ≥ 6 years with CSU who remained symptomatic despite H1-antihistamine treatment. Patients were randomized to receive dupilumab 300 mg every 2 weeks (q2w; n = 70) or placebo q2w (n = 68). The current analysis evaluated the change from baseline to week 12 and week 24 in the total scores of the Dermatology Life Quality Index (DLQI), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and EuroQol (EQ)-Visual Analog Scale (VAS). Additional outcomes included changes from baseline to week 12 and week 24 in DLQI severity categories and the proportion of patients reporting “not at all/a little” effect on individual items of DLQI and CU-Q2oL questionnaires.

Results

At week 24, dupilumab significantly improved total DLQI and CU-Q2oL scores compared with placebo {difference: −3.2 (95% confidence interval [CI] −5.2 to −1.1; nominal p = 0.0026) and −8.6 (95% CI −14.6 to −2.6; nominal p = 0.0049), respectively}, as well as EQ-VAS score (difference: 6.0 [95% CI 0.9 to 11.2; nominal p = 0.0210]). Similar trends were observed for week 12. Significantly more dupilumab versus placebo recipients reported “no or little” effect for most of the DLQI and CU-Q2oL items (nominal p < 0.05).

Conclusions

Dupilumab significantly improved HRQoL in omalizumab-naïve patients with CSU who remained symptomatic despite standard-of-care H1-antihistamine treatment. Quality-of-life improvement with dupilumab addresses an important goal of CSU treatment.

Clinical Trial Registration

ClinicalTrials.gov identifier: NCT04180488.