Ditte Georgina Zhang, Mia-Louise Nielsen, Jennifer Astrup Sørensen, Somaia Naassan, Christian Vestergaard, Emek Kocatürk, Zarqa Ali, Jacob P. Thyssen, Alexander Egeberg, Simon Francis Thomsen
{"title":"成年慢性自发性荨麻疹患者的Omalizumab给药模式和药物生存期。","authors":"Ditte Georgina Zhang, Mia-Louise Nielsen, Jennifer Astrup Sørensen, Somaia Naassan, Christian Vestergaard, Emek Kocatürk, Zarqa Ali, Jacob P. Thyssen, Alexander Egeberg, Simon Francis Thomsen","doi":"10.1111/jdv.20737","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Omalizumab is an effective treatment for chronic spontaneous urticaria (CSU), but strategies and predictors for guiding long-term management and discontinuation remain limited.</p>\n </section>\n \n <section>\n \n <h3> Objectives</h3>\n \n <p>To examine real-world treatment patterns, including dosing modifications and discontinuation, and identify potential predictive factors for these outcomes.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This was a retrospective, observational, real-life study of adult patients with CSU treated with omalizumab at a Urticaria Center of Reference and Excellence (UCARE) in Copenhagen, Denmark, between May 20, 2015, and April 4, 2024. The Kaplan-Meier estimator was used to visualize time to discontinuation and dose escalation/reduction (using standard label dosing as reference), and Cox-regressions with hazard ratios (HR) were used to investigate potential predictive variables.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of 430 patients initiated on omalizumab, 139 (32.4%) escalated treatment, 161 (37.5%) reduced treatment, and 90 (21.0%) discontinued treatment directly from the standard dose. The median survival time for dose escalation was 2 years (95% CI: 1.17–3.55), and the strongest predictor was a positive basophil histamine release assay (BHRA) (HR: 2.79, 95% CI: 1.69–4.61). Fast treatment response (HR: 0.50, 95% CI: 0.33–0.75) and higher baseline UCT scores (HR: 0.89, 95% CI: 0.82–0.97) decreased the risk of dose escalation. The median survival time to dose reduction was 1.2 years (95% CI: 0.98–1.49) and was more likely in males (HR: 1.68, 95% CI: 1.13–2.50) and patients with fast treatment response (HR: 1.66, 95% CI: 1.12–2.48). Median survival time to discontinuation (all reasons) of omalizumab was 3 years (95% CI: 2.35–3.64).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>A considerable proportion of patients with CSU require modifications to the recommended omalizumab dosing regimen. A positive BHRA was the strongest predictor for dose escalation, while male sex and fast treatment response were the strongest predictors for dose reduction. Our study highlights the need for individualized strategies in managing CSU.</p>\n </section>\n </div>","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":"39 10","pages":"1796-1805"},"PeriodicalIF":8.0000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Omalizumab dosing patterns and drug survival in adult patients with chronic spontaneous urticaria\",\"authors\":\"Ditte Georgina Zhang, Mia-Louise Nielsen, Jennifer Astrup Sørensen, Somaia Naassan, Christian Vestergaard, Emek Kocatürk, Zarqa Ali, Jacob P. Thyssen, Alexander Egeberg, Simon Francis Thomsen\",\"doi\":\"10.1111/jdv.20737\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Omalizumab is an effective treatment for chronic spontaneous urticaria (CSU), but strategies and predictors for guiding long-term management and discontinuation remain limited.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Objectives</h3>\\n \\n <p>To examine real-world treatment patterns, including dosing modifications and discontinuation, and identify potential predictive factors for these outcomes.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This was a retrospective, observational, real-life study of adult patients with CSU treated with omalizumab at a Urticaria Center of Reference and Excellence (UCARE) in Copenhagen, Denmark, between May 20, 2015, and April 4, 2024. The Kaplan-Meier estimator was used to visualize time to discontinuation and dose escalation/reduction (using standard label dosing as reference), and Cox-regressions with hazard ratios (HR) were used to investigate potential predictive variables.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Of 430 patients initiated on omalizumab, 139 (32.4%) escalated treatment, 161 (37.5%) reduced treatment, and 90 (21.0%) discontinued treatment directly from the standard dose. The median survival time for dose escalation was 2 years (95% CI: 1.17–3.55), and the strongest predictor was a positive basophil histamine release assay (BHRA) (HR: 2.79, 95% CI: 1.69–4.61). Fast treatment response (HR: 0.50, 95% CI: 0.33–0.75) and higher baseline UCT scores (HR: 0.89, 95% CI: 0.82–0.97) decreased the risk of dose escalation. The median survival time to dose reduction was 1.2 years (95% CI: 0.98–1.49) and was more likely in males (HR: 1.68, 95% CI: 1.13–2.50) and patients with fast treatment response (HR: 1.66, 95% CI: 1.12–2.48). Median survival time to discontinuation (all reasons) of omalizumab was 3 years (95% CI: 2.35–3.64).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>A considerable proportion of patients with CSU require modifications to the recommended omalizumab dosing regimen. A positive BHRA was the strongest predictor for dose escalation, while male sex and fast treatment response were the strongest predictors for dose reduction. Our study highlights the need for individualized strategies in managing CSU.</p>\\n </section>\\n </div>\",\"PeriodicalId\":17351,\"journal\":{\"name\":\"Journal of the European Academy of Dermatology and Venereology\",\"volume\":\"39 10\",\"pages\":\"1796-1805\"},\"PeriodicalIF\":8.0000,\"publicationDate\":\"2025-05-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the European Academy of Dermatology and Venereology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/jdv.20737\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the European Academy of Dermatology and Venereology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/jdv.20737","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Omalizumab dosing patterns and drug survival in adult patients with chronic spontaneous urticaria
Background
Omalizumab is an effective treatment for chronic spontaneous urticaria (CSU), but strategies and predictors for guiding long-term management and discontinuation remain limited.
Objectives
To examine real-world treatment patterns, including dosing modifications and discontinuation, and identify potential predictive factors for these outcomes.
Methods
This was a retrospective, observational, real-life study of adult patients with CSU treated with omalizumab at a Urticaria Center of Reference and Excellence (UCARE) in Copenhagen, Denmark, between May 20, 2015, and April 4, 2024. The Kaplan-Meier estimator was used to visualize time to discontinuation and dose escalation/reduction (using standard label dosing as reference), and Cox-regressions with hazard ratios (HR) were used to investigate potential predictive variables.
Results
Of 430 patients initiated on omalizumab, 139 (32.4%) escalated treatment, 161 (37.5%) reduced treatment, and 90 (21.0%) discontinued treatment directly from the standard dose. The median survival time for dose escalation was 2 years (95% CI: 1.17–3.55), and the strongest predictor was a positive basophil histamine release assay (BHRA) (HR: 2.79, 95% CI: 1.69–4.61). Fast treatment response (HR: 0.50, 95% CI: 0.33–0.75) and higher baseline UCT scores (HR: 0.89, 95% CI: 0.82–0.97) decreased the risk of dose escalation. The median survival time to dose reduction was 1.2 years (95% CI: 0.98–1.49) and was more likely in males (HR: 1.68, 95% CI: 1.13–2.50) and patients with fast treatment response (HR: 1.66, 95% CI: 1.12–2.48). Median survival time to discontinuation (all reasons) of omalizumab was 3 years (95% CI: 2.35–3.64).
Conclusions
A considerable proportion of patients with CSU require modifications to the recommended omalizumab dosing regimen. A positive BHRA was the strongest predictor for dose escalation, while male sex and fast treatment response were the strongest predictors for dose reduction. Our study highlights the need for individualized strategies in managing CSU.
期刊介绍：
The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV).
The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology.
The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
