Abstract：
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
目标：Tixagevimab/cilgavimab是两种长效单克隆抗体的混合物，被批准用于免疫功能低下（IC）或高危患者的严重急性呼吸综合征冠状病毒-2（SARS-CoV-2）感染（2019年冠状病毒病[COVID-19]）的暴露前预防（PrEP）。我们调查了在日本现实世界中使用tixagevimab/cilgavimab进行PrEP的IC患者的患者特征和临床结果。
方法：这项观察性研究使用了来自Real-WorldDataCo.的匿名二次数据。Ltd.针对年龄≥12岁的IC患者，于2022年9月至2023年9月期间服用tixagevimab/cilgavimab。我们分析了在给药后6个月内COVID-19相关临床结局的基线特征和事件发生率。
结果：分析了397例IC患者的数据。约一半（53.4％）为男性，中位年龄为71.0（四分位距61.0，77.0）岁。恶性肿瘤（97.2%），心血管疾病（71.3%），糖尿病(66.5%)是常见的合并症。全身性皮质类固醇和免疫抑制剂的处方为87.4％和24.9％，分别。两种最常见的目标临床状况是血液系统恶性肿瘤的积极治疗（88.2％）和B细胞消耗疗法的治疗（57.4％）。接受医学治疗的COVID-19、COVID-19住院的每100人-月事件发生率（95%置信区间；数字），COVID-19导致的住院死亡率和全因死亡为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），分别。
结论：这是第一份使用多中心数据库描述日本现实环境中使用替沙格维单抗/西加维单抗的IC患者的临床特征和与COVID-19相关的结果的报告。接受tixagevimab/cilgavimab的IC患者队列包括许多患有合并症的老年患者。
方法：这项观察性研究使用了来自Real-WorldDataCo.的匿名二次数据。Ltd.针对年龄≥12岁的IC患者，于2022年9月至2023年9月期间服用tixagevimab/cilgavimab。我们分析了在给药后6个月内COVID-19相关临床结局的基线特征和事件发生率。
结果：分析了397例IC患者的数据。约一半（53.4％）为男性，中位年龄为71.0（四分位距61.0，77.0）岁。恶性肿瘤（97.2%），心血管疾病（71.3%），糖尿病(66.5%)是常见的合并症。全身性皮质类固醇和免疫抑制剂的处方为87.4％和24.9％，分别。两种最常见的目标临床状况是血液系统恶性肿瘤的积极治疗（88.2％）和B细胞消耗疗法的治疗（57.4％）。接受医学治疗的COVID-19、COVID-19住院的每100人-月事件发生率（95%置信区间；数字），COVID-19导致的住院死亡率和全因死亡为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），分别。
结论：这是第一份使用多中心数据库描述日本现实环境中使用替沙格维单抗/西加维单抗的IC患者的临床特征和与COVID-19相关的结果的报告。接受tixagevimab/cilgavimab的IC患者队列包括许多患有合并症的老年患者。
