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Background <p>Chronic spontaneous urticaria (CSU) is a skin condition characterized by itchy hives and/or angioedema, impairing patients’ quality of life even with the current available medications. This study aims to evaluate the efficacy and safety of Ligelizumab, a high-affinity monoclonal anti-IgE antibody, in the treatment of CSU.</p> Methods <p>We performed a systematic review and meta-analysis in accordance with PRISMA criteria, methodically exploring databases for randomized controlled trials (RCTs) comparing Ligelizumab with placebo in patients with CSU. Studies that reported outcomes like the itch severity score (ISS7), the hives severity score (HSS7), and adverse events were included in our analysis.</p> Results <p>Four RCTs were included in our analysis with a total of 2,481 patients with CSU. Ligelizumab significantly improved urticaria symptoms as measured by change in ISS7 at week 12 in adults (MD = -3.67, 95% CI: [-4.25 to -3.09], p &lt; 0.00001), change in UAS7 at week 12 in adults (MD = -9.18, 95% CI: [-10.45 to -7.92], p &lt; 0.00001), and change in UAS7 at week 12 in adolescents (MD = -6.48, 95% CI: [-12.84 to -0.12], <i>p</i> = 0.05). Regarding safety outcomes, only Ligelizumab 120mg showed significantly higher upper respiratory tract infection rates (RR = 2.70, 95% CI [1.17 to 6.21], <i>p</i> = 0.02).</p> Conclusion <p>Our findings suggest that Ligelizumab, at doses 72 and 120 mg, might be able to improve the symptoms of CSU evidenced by the improvements in ISS7 UAS7 and UAS7 response rate and the overall quality of life with an acceptable safety profile with certain concerns regarding Ligelizumab 120 mg causing upper respiratory tract infections. However, the small number of studies included limit the generalizability of our results.</p>

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Efficacy and safety of different doses of ligelizumab in patients with chronic spontaneous urticaria: a systematic review and meta-analysis of randomized controlled trials with GRADE evaluation

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月18日

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  • Lamees Taman,
  • Mohamed Abo Zeid,
  • Kareem Khalefa,
  • Habiba Tariq Saeed,
  • Amr Alaa Azzouz Elkelany,
  • Habiba Abdelhameed Elrefaey,
  • Amr M. Abou Elezz

摘要

Background

Chronic spontaneous urticaria (CSU) is a skin condition characterized by itchy hives and/or angioedema, impairing patients’ quality of life even with the current available medications. This study aims to evaluate the efficacy and safety of Ligelizumab, a high-affinity monoclonal anti-IgE antibody, in the treatment of CSU.

Methods

We performed a systematic review and meta-analysis in accordance with PRISMA criteria, methodically exploring databases for randomized controlled trials (RCTs) comparing Ligelizumab with placebo in patients with CSU. Studies that reported outcomes like the itch severity score (ISS7), the hives severity score (HSS7), and adverse events were included in our analysis.

Results

Four RCTs were included in our analysis with a total of 2,481 patients with CSU. Ligelizumab significantly improved urticaria symptoms as measured by change in ISS7 at week 12 in adults (MD = -3.67, 95% CI: [-4.25 to -3.09], p < 0.00001), change in UAS7 at week 12 in adults (MD = -9.18, 95% CI: [-10.45 to -7.92], p < 0.00001), and change in UAS7 at week 12 in adolescents (MD = -6.48, 95% CI: [-12.84 to -0.12], p = 0.05). Regarding safety outcomes, only Ligelizumab 120mg showed significantly higher upper respiratory tract infection rates (RR = 2.70, 95% CI [1.17 to 6.21], p = 0.02).

Conclusion

Our findings suggest that Ligelizumab, at doses 72 and 120 mg, might be able to improve the symptoms of CSU evidenced by the improvements in ISS7 UAS7 and UAS7 response rate and the overall quality of life with an acceptable safety profile with certain concerns regarding Ligelizumab 120 mg causing upper respiratory tract infections. However, the small number of studies included limit the generalizability of our results.