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Background&#xa0;and Objective <p>This meta-analysis aims to evaluate ligelizumab’s efficacy and safety for chronic spontaneous urticaria (CSU) treatment by analyzing recent clinical trials and comparing it with placebo and omalizumab.</p> Methods <p>PubMed, Embase, and Cochrane were searched up to October 2024. Eligible studies were randomized controlled trials (RCTs) comparing ligelizumab with placebo or omalizumab, reporting relevant outcomes. Nonrandomized studies, or those without control groups, were excluded. Risk of bias was assessed using the Cochrane RoB-2 tool, and the Grading of Recommendation, Assessment, Development, and Evaluations approach rated evidence certainty. Statistical analysis used R software (v.4.4.2), assessing heterogeneity by Cochran Q and <i>I</i><sup>2</sup> statistics.</p> Results <p>Four RCTs with 2488 patients were included. Ligelizumab (&lt; 72&#xa0;mg) significantly improved itch severity score over 7&#xa0;days (ISS7) [risk ratio (RR) 5.07; 95% confidence interval (CI) 3.12–8.24; prediction interval (PI) 2.31–11.15; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 0%], urticaria activity score over 7 days (UAS7) (RR 4.61; 95% CI 1.84–11.59; PI 0.34–62.49; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 55%), and overall urticaria activity (RR 4.26; 95% CI 2.63–6.92; PI 0.18–98.29; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 0%) versus placebo. The &gt; 72 mg dose showed greater improvements in ISS7 (RR 5.12; 95% CI 2.72–9.64; PI 1.14–22.96; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 45%), UAS7 (RR 5.35; 95% CI 3.04–9.40; PI 1.78–16.08; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 31%), and overall activity (RR 4.34; 95% CI 2.67–7.04; PI 0.19–99.80; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 0%). Compared with ligelizumab (&gt; 72&#xa0;mg), omalizumab had fewer injection site reactions (RR 3.04; 95% CI 1.95–4.73; PI 0.17–53.81; <i>P</i> &lt; 0.01; <i>I</i><sup>2</sup> = 0%) and erythema (RR 5.05; 95% CI 1.33–19.13; PI 0.08–312.57; <i>P</i> = 0.02; <i>I</i><sup>2</sup> = 17%). Moderate certainty evidence indicated that ≤ 72&#xa0;mg probably improved ISS7, overall urticaria activity, and UAS7. For &gt; 72&#xa0;mg, improvements in overall urticaria activity were seen, but ISS7 and UAS7 were classified as low quality of evidence.</p> Discussion <p>Ligelizumab significantly improves CSU symptoms compared with placebo, reducing disease severity, itching, and hives, with similar safety to omalizumab. Ligelizumab’s higher affinity for immunoglobulin E (IgE) may provide better symptom control. Limitations include a small number of studies, short follow-up periods, and patient variability.</p> Protocol Registration <p>International Prospective Register of Systematic Reviews (PROSPERO), CRD42024593072.</p>

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Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria: A Systematic Review and Meta-analysis of Randomized Controlled Trials

  • 期刊论文

  • 发表日期：

    2025年4月4日

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  • Ana Carolina Putini Vieira,
  • Ana Carolina Ventura de Santana de Jesus,
  • Anelise Poluboiarinov Cappellaro,
  • Lucas M. Barbosa,
  • Ana Clara Felix de Farias Santos,
  • Carolina Mira Dilly de Medeiros,
  • Mable Pereira,
  • Gabriel Gomes Lopes,
  • Fernanda Valeriano Zamora

摘要

Background and Objective

This meta-analysis aims to evaluate ligelizumab’s efficacy and safety for chronic spontaneous urticaria (CSU) treatment by analyzing recent clinical trials and comparing it with placebo and omalizumab.

Methods

PubMed, Embase, and Cochrane were searched up to October 2024. Eligible studies were randomized controlled trials (RCTs) comparing ligelizumab with placebo or omalizumab, reporting relevant outcomes. Nonrandomized studies, or those without control groups, were excluded. Risk of bias was assessed using the Cochrane RoB-2 tool, and the Grading of Recommendation, Assessment, Development, and Evaluations approach rated evidence certainty. Statistical analysis used R software (v.4.4.2), assessing heterogeneity by Cochran Q and I2 statistics.

Results

Four RCTs with 2488 patients were included. Ligelizumab (< 72 mg) significantly improved itch severity score over 7 days (ISS7) [risk ratio (RR) 5.07; 95% confidence interval (CI) 3.12–8.24; prediction interval (PI) 2.31–11.15; P < 0.01; I2 = 0%], urticaria activity score over 7 days (UAS7) (RR 4.61; 95% CI 1.84–11.59; PI 0.34–62.49; P < 0.01; I2 = 55%), and overall urticaria activity (RR 4.26; 95% CI 2.63–6.92; PI 0.18–98.29; P < 0.01; I2 = 0%) versus placebo. The > 72 mg dose showed greater improvements in ISS7 (RR 5.12; 95% CI 2.72–9.64; PI 1.14–22.96; P < 0.01; I2 = 45%), UAS7 (RR 5.35; 95% CI 3.04–9.40; PI 1.78–16.08; P < 0.01; I2 = 31%), and overall activity (RR 4.34; 95% CI 2.67–7.04; PI 0.19–99.80; P < 0.01; I2 = 0%). Compared with ligelizumab (> 72 mg), omalizumab had fewer injection site reactions (RR 3.04; 95% CI 1.95–4.73; PI 0.17–53.81; P < 0.01; I2 = 0%) and erythema (RR 5.05; 95% CI 1.33–19.13; PI 0.08–312.57; P = 0.02; I2 = 17%). Moderate certainty evidence indicated that ≤ 72 mg probably improved ISS7, overall urticaria activity, and UAS7. For > 72 mg, improvements in overall urticaria activity were seen, but ISS7 and UAS7 were classified as low quality of evidence.

Discussion

Ligelizumab significantly improves CSU symptoms compared with placebo, reducing disease severity, itching, and hives, with similar safety to omalizumab. Ligelizumab’s higher affinity for immunoglobulin E (IgE) may provide better symptom control. Limitations include a small number of studies, short follow-up periods, and patient variability.

Protocol Registration

International Prospective Register of Systematic Reviews (PROSPERO), CRD42024593072.