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<p>Chronic spontaneous urticaria (CSU) is a distressing skin disorder characterized by recurrent wheals, angioedema, and persistent itching lasting more than 6 weeks. Remibrutinib, a selective oral Bruton’s tyrosine kinase (BTK) inhibitor, has shown potential as a novel therapy for patients who remain symptomatic despite standard antihistamine treatment. This study aimed to evaluate the efficacy and safety of remibrutinib. A comprehensive search was conducted across PubMed, Scopus, Web of Science, Cochrane CENTRAL, and ClinicalTrials.gov up to March 2025. Primary outcomes included changes in the weekly Urticaria Activity Score (UAS7), the proportion of patients achieving low disease activity (UAS7 ≤ 6) or complete symptom resolution (UAS7 = 0), and Dermatology Life Quality Index (DLQI) scores. Safety outcomes were assessed by evaluating adverse events, serious adverse events, and treatment discontinuations. Subgroup analyses explored the effects of different remibrutinib doses. Three RCTs involving 1,236 patients met the inclusion criteria. Remibrutinib 25&#xa0;mg twice daily significantly reduced UAS7 scores compared to placebo by week 2 (mean difference [MD] = − 11.50; 95% CI − 14.23 to − 8.77; <i>P</i> &lt; 0.00001), with sustained improvement at week 12 (MD = − 7.82; 95% CI − 10.31 to − 5.33; <i>P</i> &lt; 0.00001) and week 24 (MD = − 5.66; 95% CI − 7.62 to − 3.70; <i>P</i> &lt; 0.00001). More patients achieved low disease activity or complete resolution with remibrutinib, and DLQI scores improved accordingly. The safety profile of remibrutinib was comparable to placebo, with no significant differences in serious adverse events, overall adverse events, or discontinuations. These findings support remibrutinib 25&#xa0;mg twice daily as an effective and well-tolerated oral treatment for antihistamine-refractory CSU. Its rapid onset, sustained benefit, and favorable safety profile make it a strong candidate for inclusion in future CSU treatment guidelines.</p>

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Efficacy and safety of remibrutinib in chronic spontaneous urticaria: a systematic review and meta-analysis of data up to 24 weeks

  • 期刊论文

  • 发表日期：

    2025年12月5日

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  • Alhasan Altayf,
  • Ahmed Farid Gadelmawla,
  • Munder Lateiresh,
  • Omar Khasawneh,
  • Muhammed Elhadi

摘要

Chronic spontaneous urticaria (CSU) is a distressing skin disorder characterized by recurrent wheals, angioedema, and persistent itching lasting more than 6 weeks. Remibrutinib, a selective oral Bruton’s tyrosine kinase (BTK) inhibitor, has shown potential as a novel therapy for patients who remain symptomatic despite standard antihistamine treatment. This study aimed to evaluate the efficacy and safety of remibrutinib. A comprehensive search was conducted across PubMed, Scopus, Web of Science, Cochrane CENTRAL, and ClinicalTrials.gov up to March 2025. Primary outcomes included changes in the weekly Urticaria Activity Score (UAS7), the proportion of patients achieving low disease activity (UAS7 ≤ 6) or complete symptom resolution (UAS7 = 0), and Dermatology Life Quality Index (DLQI) scores. Safety outcomes were assessed by evaluating adverse events, serious adverse events, and treatment discontinuations. Subgroup analyses explored the effects of different remibrutinib doses. Three RCTs involving 1,236 patients met the inclusion criteria. Remibrutinib 25 mg twice daily significantly reduced UAS7 scores compared to placebo by week 2 (mean difference [MD] = − 11.50; 95% CI − 14.23 to − 8.77; P < 0.00001), with sustained improvement at week 12 (MD = − 7.82; 95% CI − 10.31 to − 5.33; P < 0.00001) and week 24 (MD = − 5.66; 95% CI − 7.62 to − 3.70; P < 0.00001). More patients achieved low disease activity or complete resolution with remibrutinib, and DLQI scores improved accordingly. The safety profile of remibrutinib was comparable to placebo, with no significant differences in serious adverse events, overall adverse events, or discontinuations. These findings support remibrutinib 25 mg twice daily as an effective and well-tolerated oral treatment for antihistamine-refractory CSU. Its rapid onset, sustained benefit, and favorable safety profile make it a strong candidate for inclusion in future CSU treatment guidelines.