{"title":"日本接受替沙吉单抗/西格维单抗暴露前预防治疗的免疫功能低下患者的临床特征和 COVID-19 相关结果。","authors":"Toshibumi Taniguchi, Tomoyuki Homma, Yoichi Tamai, Yoshifumi Arita, Masakazu Fujiwara, Naho Kuroishi, Keiji Sugiyama, Shinichi Kanazu, Atsushi Maruyama","doi":"10.1016/j.jiac.2024.07.007","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Tixagevimab/cilgavimab is a cocktail of two long-acting monoclonal antibodies approved for pre-exposure prophylaxis (PrEP) of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (cause of coronavirus disease 2019 [COVID-19]) in immunocompromised (IC) or high-risk patients. We investigated the patient characteristics and clinical outcomes of IC patients administered tixagevimab/cilgavimab for PrEP in real-world use in Japan.</p><p><strong>Methods: </strong>This observational study used anonymous secondary data from Real-World Data Co., Ltd. for IC patients aged ≥12 years administered tixagevimab/cilgavimab between September 2022 and September 2023. We analyzed the baseline characteristics and event-rates of COVID-19-related clinical outcomes within 6 months of administration.</p><p><strong>Results: </strong>Data were analyzed for 397 IC patients. About half (53.4 %) were male and the median age was 71.0 (interquartile range 61.0, 77.0) years. Malignancy (97.2 %), cardiovascular disease (71.3 %), and diabetes (66.5 %) were frequent comorbidities. Systemic corticosteroids and immunosuppressants were prescribed to 87.4 % and 24.9 %, respectively. The two most common target clinical conditions were active therapy for hematologic malignancies (88.2 %) and treatment with B cell-depleting therapies (57.4 %). The event-rates per 100 person-months (95 % confidence interval; number) for medically attended COVID-19, COVID-19 hospitalization, in-hospital mortality due to COVID-19, and all-cause death were 4.14 (3.06-5.48; n = 49), 1.74 (1.09-2.64; n = 22), 0.07 (0.00-0.42; n = 1), and 0.60 (0.26-1.17; n = 8), respectively.</p><p><strong>Conclusion: </strong>This is the first report using a multicenter database to describe the clinical characteristics and COVID-19-related outcomes of IC patients administered with tixagevimab/cilgavimab in real-world settings in Japan. This cohort of IC patients who received tixagevimab/cilgavimab included many elderly patients with comorbidities.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical characteristics and COVID-19-related outcomes of immunocompromised patients receiving tixagevimab/cilgavimab pre-exposure prophylaxis in Japan.\",\"authors\":\"Toshibumi Taniguchi, Tomoyuki Homma, Yoichi Tamai, Yoshifumi Arita, Masakazu Fujiwara, Naho Kuroishi, Keiji Sugiyama, Shinichi Kanazu, Atsushi Maruyama\",\"doi\":\"10.1016/j.jiac.2024.07.007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Tixagevimab/cilgavimab is a cocktail of two long-acting monoclonal antibodies approved for pre-exposure prophylaxis (PrEP) of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (cause of coronavirus disease 2019 [COVID-19]) in immunocompromised (IC) or high-risk patients. We investigated the patient characteristics and clinical outcomes of IC patients administered tixagevimab/cilgavimab for PrEP in real-world use in Japan.</p><p><strong>Methods: </strong>This observational study used anonymous secondary data from Real-World Data Co., Ltd. for IC patients aged ≥12 years administered tixagevimab/cilgavimab between September 2022 and September 2023. We analyzed the baseline characteristics and event-rates of COVID-19-related clinical outcomes within 6 months of administration.</p><p><strong>Results: </strong>Data were analyzed for 397 IC patients. About half (53.4 %) were male and the median age was 71.0 (interquartile range 61.0, 77.0) years. Malignancy (97.2 %), cardiovascular disease (71.3 %), and diabetes (66.5 %) were frequent comorbidities. Systemic corticosteroids and immunosuppressants were prescribed to 87.4 % and 24.9 %, respectively. The two most common target clinical conditions were active therapy for hematologic malignancies (88.2 %) and treatment with B cell-depleting therapies (57.4 %). The event-rates per 100 person-months (95 % confidence interval; number) for medically attended COVID-19, COVID-19 hospitalization, in-hospital mortality due to COVID-19, and all-cause death were 4.14 (3.06-5.48; n = 49), 1.74 (1.09-2.64; n = 22), 0.07 (0.00-0.42; n = 1), and 0.60 (0.26-1.17; n = 8), respectively.</p><p><strong>Conclusion: </strong>This is the first report using a multicenter database to describe the clinical characteristics and COVID-19-related outcomes of IC patients administered with tixagevimab/cilgavimab in real-world settings in Japan. This cohort of IC patients who received tixagevimab/cilgavimab included many elderly patients with comorbidities.</p>\",\"PeriodicalId\":16103,\"journal\":{\"name\":\"Journal of Infection and Chemotherapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-07-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Infection and Chemotherapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jiac.2024.07.007\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Infection and Chemotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jiac.2024.07.007","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
摘要
研究目的Tixagevimab/cilgavimab是一种由两种长效单克隆抗体组成的鸡尾酒，已被批准用于免疫力低下（IC）或高风险患者的严重急性呼吸系统综合征冠状病毒-2（SARS-CoV-2）感染（冠状病毒病2019年病因[COVID-19]）的暴露前预防（PrEP）。我们调查了在日本实际使用替沙吉单抗/西格维单抗进行 PrEP 的 IC 患者的特征和临床结果：本观察性研究使用了 Real-World Data Co., Ltd. 提供的匿名二手数据，研究对象为 2022 年 9 月至 2023 年 9 月期间接受替沙吉单抗/西格维单抗治疗的年龄≥12 岁的 IC 患者。我们分析了用药后6个月内COVID-19相关临床结果的基线特征和事件发生率：我们分析了 397 例 IC 患者的数据。约半数（53.4%）为男性，中位年龄为 71.0 岁（四分位距为 61.0 至 77.0）。恶性肿瘤（97.2%）、心血管疾病（71.3%）和糖尿病（66.5%）是常见的合并症。87.4%和24.9%的患者分别服用了全身性皮质类固醇和免疫抑制剂。两个最常见的目标临床条件是血液恶性肿瘤的积极治疗（88.2%）和 B 细胞消耗疗法的治疗（57.4%）。每百人月的COVID-19就诊率、COVID-19住院率、COVID-19导致的院内死亡率和全因死亡率分别为4.14（3.06-5.48；n=49）、1.74（1.09-2.64；n=22）、0.07（0.00-0.42；n=1）和0.60（0.26-1.17；n=8）：这是第一份使用多中心数据库描述日本真实世界中使用替沙吉单抗/西格维单抗的IC患者的临床特征和COVID-19相关结果的报告。接受替沙吉单抗/西格维单抗治疗的IC患者队列中包括许多患有合并症的老年患者。
Clinical characteristics and COVID-19-related outcomes of immunocompromised patients receiving tixagevimab/cilgavimab pre-exposure prophylaxis in Japan.
Objective: Tixagevimab/cilgavimab is a cocktail of two long-acting monoclonal antibodies approved for pre-exposure prophylaxis (PrEP) of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (cause of coronavirus disease 2019 [COVID-19]) in immunocompromised (IC) or high-risk patients. We investigated the patient characteristics and clinical outcomes of IC patients administered tixagevimab/cilgavimab for PrEP in real-world use in Japan.
Methods: This observational study used anonymous secondary data from Real-World Data Co., Ltd. for IC patients aged ≥12 years administered tixagevimab/cilgavimab between September 2022 and September 2023. We analyzed the baseline characteristics and event-rates of COVID-19-related clinical outcomes within 6 months of administration.
Results: Data were analyzed for 397 IC patients. About half (53.4 %) were male and the median age was 71.0 (interquartile range 61.0, 77.0) years. Malignancy (97.2 %), cardiovascular disease (71.3 %), and diabetes (66.5 %) were frequent comorbidities. Systemic corticosteroids and immunosuppressants were prescribed to 87.4 % and 24.9 %, respectively. The two most common target clinical conditions were active therapy for hematologic malignancies (88.2 %) and treatment with B cell-depleting therapies (57.4 %). The event-rates per 100 person-months (95 % confidence interval; number) for medically attended COVID-19, COVID-19 hospitalization, in-hospital mortality due to COVID-19, and all-cause death were 4.14 (3.06-5.48; n = 49), 1.74 (1.09-2.64; n = 22), 0.07 (0.00-0.42; n = 1), and 0.60 (0.26-1.17; n = 8), respectively.
Conclusion: This is the first report using a multicenter database to describe the clinical characteristics and COVID-19-related outcomes of IC patients administered with tixagevimab/cilgavimab in real-world settings in Japan. This cohort of IC patients who received tixagevimab/cilgavimab included many elderly patients with comorbidities.
期刊介绍：
The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.
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