Ahmed Ali Khan, Abdul Ahad Riaz, Faisal Naseer, Noor Fatima, Zuhair Abrar, Linta Malik, Jumana Khan, Raza Aslam, Ahmed Abdul Rab, Allahdad Khan
{"title":"瑞米鲁替尼治疗慢性自发性荨麻疹的疗效、安全性和生活质量：系统回顾和荟萃分析。","authors":"Ahmed Ali Khan, Abdul Ahad Riaz, Faisal Naseer, Noor Fatima, Zuhair Abrar, Linta Malik, Jumana Khan, Raza Aslam, Ahmed Abdul Rab, Allahdad Khan","doi":"10.1016/j.jaip.2025.09.023","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Chronic spontaneous urticaria (CSU) is a mast cell-mediated condition affecting ∼1% of the population and is often refractory to antihistamines and omalizumab. Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, prevents mast cell activation independent of the IgE pathway.</p><p><strong>Objective: </strong>To assess the efficacy, safety, and quality-of-life outcomes (QoL) of remibrutinib compared to placebo in adults with refractory CSU.</p><p><strong>Methods: </strong>A systematic review was conducted per PRISMA guidelines. Three RCTs (n=997) and two single-arm studies (n=280) evaluating remibrutinib in CSU were included. Specific disease activity endpoints assessed included changes in Urticaria Activity Score (UAS7), Hives Severity Score (HSS7), Itch Severity Score (ISS7), Angioedema Activity Score (AAS7), and Dermatology Life Quality Index (DLQI). The risk of bias was evaluated using the Cochrane RoB-2 tool for RCTs and ROBINS-I for single-arm studies. Meta-analysis was performed using a random-effects model.</p><p><strong>Results: </strong>In the pooled analysis of RCTs, remibrutinib effectively decreased UAS7 at Week 12 compared to placebo (MD -7.81, 95% CI: -10.29 to -5.33), with improvements in itch and hives severity scores (MD -2.94, 95% CI: -3.73 to -2.15, and MD -4.05, 95% CI: -4.98 to -3.12, respectively). Remibrutinib increased the likelihood of achieving complete response (UAS7=0; RR 3.32, 95% CI: 2.34 to 4.71), controlled disease (UAS7≤6; RR 2.13, 95% CI: 1.73 to 2.62), and minimal quality-of-life impact (DLQI ≤ 1; RR 1.84, 95% CI: 1.47 to 2.30). REMIX-1 and REMIX-2 trials showed significantly better disease control (UAS7≤6) by week 2 (RR 6.81, 95% CI: 3.45 to 13.42). Adverse event rates with remibrutinib were similar to placebo, except for increased nasopharyngitis, upper respiratory tract infection, and petechiae (RR 1.88, 95% CI: 1.11 to 3.19; RR 2.88, 95% CI: 1.30 to 6.41; and RR=7.52, 95% Cl: 1.44 to 39.20, respectively) Evidence from single-arm studies (BISCUIT at 24 weeks and Jain 2024 at 52 weeks) suggested sustained long-term efficacy and tolerability.</p><p><strong>Conclusion: </strong>Remibrutinib shows rapid symptom improvement with an acceptable safety profile in refractory CSU and appears to be a promising oral option for antihistamine-refractory CSU based on short-term data.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":" ","pages":""},"PeriodicalIF":6.6000,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy, Safety, and Quality-of-Life Outcomes of Remibrutinib in Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis.\",\"authors\":\"Ahmed Ali Khan, Abdul Ahad Riaz, Faisal Naseer, Noor Fatima, Zuhair Abrar, Linta Malik, Jumana Khan, Raza Aslam, Ahmed Abdul Rab, Allahdad Khan\",\"doi\":\"10.1016/j.jaip.2025.09.023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Chronic spontaneous urticaria (CSU) is a mast cell-mediated condition affecting ∼1% of the population and is often refractory to antihistamines and omalizumab. Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, prevents mast cell activation independent of the IgE pathway.</p><p><strong>Objective: </strong>To assess the efficacy, safety, and quality-of-life outcomes (QoL) of remibrutinib compared to placebo in adults with refractory CSU.</p><p><strong>Methods: </strong>A systematic review was conducted per PRISMA guidelines. Three RCTs (n=997) and two single-arm studies (n=280) evaluating remibrutinib in CSU were included. Specific disease activity endpoints assessed included changes in Urticaria Activity Score (UAS7), Hives Severity Score (HSS7), Itch Severity Score (ISS7), Angioedema Activity Score (AAS7), and Dermatology Life Quality Index (DLQI). The risk of bias was evaluated using the Cochrane RoB-2 tool for RCTs and ROBINS-I for single-arm studies. Meta-analysis was performed using a random-effects model.</p><p><strong>Results: </strong>In the pooled analysis of RCTs, remibrutinib effectively decreased UAS7 at Week 12 compared to placebo (MD -7.81, 95% CI: -10.29 to -5.33), with improvements in itch and hives severity scores (MD -2.94, 95% CI: -3.73 to -2.15, and MD -4.05, 95% CI: -4.98 to -3.12, respectively). Remibrutinib increased the likelihood of achieving complete response (UAS7=0; RR 3.32, 95% CI: 2.34 to 4.71), controlled disease (UAS7≤6; RR 2.13, 95% CI: 1.73 to 2.62), and minimal quality-of-life impact (DLQI ≤ 1; RR 1.84, 95% CI: 1.47 to 2.30). REMIX-1 and REMIX-2 trials showed significantly better disease control (UAS7≤6) by week 2 (RR 6.81, 95% CI: 3.45 to 13.42). Adverse event rates with remibrutinib were similar to placebo, except for increased nasopharyngitis, upper respiratory tract infection, and petechiae (RR 1.88, 95% CI: 1.11 to 3.19; RR 2.88, 95% CI: 1.30 to 6.41; and RR=7.52, 95% Cl: 1.44 to 39.20, respectively) Evidence from single-arm studies (BISCUIT at 24 weeks and Jain 2024 at 52 weeks) suggested sustained long-term efficacy and tolerability.</p><p><strong>Conclusion: </strong>Remibrutinib shows rapid symptom improvement with an acceptable safety profile in refractory CSU and appears to be a promising oral option for antihistamine-refractory CSU based on short-term data.</p>\",\"PeriodicalId\":51323,\"journal\":{\"name\":\"Journal of Allergy and Clinical Immunology-In Practice\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.6000,\"publicationDate\":\"2025-09-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Allergy and Clinical Immunology-In Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jaip.2025.09.023\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Allergy and Clinical Immunology-In Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaip.2025.09.023","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
Efficacy, Safety, and Quality-of-Life Outcomes of Remibrutinib in Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis.
Background: Chronic spontaneous urticaria (CSU) is a mast cell-mediated condition affecting ∼1% of the population and is often refractory to antihistamines and omalizumab. Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, prevents mast cell activation independent of the IgE pathway.
Objective: To assess the efficacy, safety, and quality-of-life outcomes (QoL) of remibrutinib compared to placebo in adults with refractory CSU.
Methods: A systematic review was conducted per PRISMA guidelines. Three RCTs (n=997) and two single-arm studies (n=280) evaluating remibrutinib in CSU were included. Specific disease activity endpoints assessed included changes in Urticaria Activity Score (UAS7), Hives Severity Score (HSS7), Itch Severity Score (ISS7), Angioedema Activity Score (AAS7), and Dermatology Life Quality Index (DLQI). The risk of bias was evaluated using the Cochrane RoB-2 tool for RCTs and ROBINS-I for single-arm studies. Meta-analysis was performed using a random-effects model.
Results: In the pooled analysis of RCTs, remibrutinib effectively decreased UAS7 at Week 12 compared to placebo (MD -7.81, 95% CI: -10.29 to -5.33), with improvements in itch and hives severity scores (MD -2.94, 95% CI: -3.73 to -2.15, and MD -4.05, 95% CI: -4.98 to -3.12, respectively). Remibrutinib increased the likelihood of achieving complete response (UAS7=0; RR 3.32, 95% CI: 2.34 to 4.71), controlled disease (UAS7≤6; RR 2.13, 95% CI: 1.73 to 2.62), and minimal quality-of-life impact (DLQI ≤ 1; RR 1.84, 95% CI: 1.47 to 2.30). REMIX-1 and REMIX-2 trials showed significantly better disease control (UAS7≤6) by week 2 (RR 6.81, 95% CI: 3.45 to 13.42). Adverse event rates with remibrutinib were similar to placebo, except for increased nasopharyngitis, upper respiratory tract infection, and petechiae (RR 1.88, 95% CI: 1.11 to 3.19; RR 2.88, 95% CI: 1.30 to 6.41; and RR=7.52, 95% Cl: 1.44 to 39.20, respectively) Evidence from single-arm studies (BISCUIT at 24 weeks and Jain 2024 at 52 weeks) suggested sustained long-term efficacy and tolerability.
Conclusion: Remibrutinib shows rapid symptom improvement with an acceptable safety profile in refractory CSU and appears to be a promising oral option for antihistamine-refractory CSU based on short-term data.
期刊介绍：
JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases.
This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders.
The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.
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