Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019).

IF 4.7 3区 医学 Q1 INFECTIOUS DISEASES
Infectious Diseases and Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-24 DOI:10.1007/s40121-024-01064-4
Dionysios Neofytos, Antonio Pagliuca, Katherine Houghton, Edward Broughton, Maria Lavinea Novis de Figueiredo Valente, Lili Jiang, David A Enoch, Beate Gruener, Raoul Herbrecht, Tobias Lahmer, Olivier Lortholary, Cléa Melenotte, Francesco Giuseppe De Rosa, Carolina Garcia-Vidal, Maria Jimenez, Maria Fernandez, Oliver Cornely
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引用次数: 0

Abstract

Introduction: Real-world data from multinational observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe.

Methods: A retrospective medical record review was conducted at 16 sites in Europe (France, Germany, Italy, Spain, and the United Kingdom). Eligible records were from patients aged ≥ 18 years at the time of isavuconazole initiation and received at least one dose of isavuconazole for suspected or confirmed invasive aspergillosis (IA) or invasive mucormycosis (IM) during the eligibility period (October 15, 2015 to June 30, 2019). Data were descriptively analysed. Success rates, overall survival, and times to these events were descriptively analysed.

Results: Data were abstracted from 218 patients (201, IA; 17, IM) who received isavuconazole as monotherapy (initiated as infusion, 52%; oral, 46%). Isavuconazole was initiated as primary therapy in 92 patients (42.2%) and salvage therapy in 121 patients (55.5%) (unknown for five patients). Mean (standard deviation) age was 56.8 (15.6) years, 66% were men and 62% had at least three comorbidities, most frequently haematologic malignancy (62%). Estimated clinical response rate at week 24 was 54.5% (95% confidence interval [CI], 38.2-66.5%) for primary treatment and 73.5% (95% CI, 62.7-81.1%) for salvage therapy. Overall, 45 patients (21%) experienced at least one adverse event (AE). Serious AEs were experienced by 37 patients (17%), with seven related to isavuconazole; five patients (2.3%) discontinued isavuconazole monotherapy due to the serious AE. A total of 137 patients (63%) died, with 17 deaths (12.4%) related to their invasive fungal infection, 11 of whom initiated isavuconazole as salvage therapy.

Conclusions: This study adds to the growing body of evidence that whether used as first-line therapy or after the failure of other antifungal therapies, isavuconazole appears to have a promising clinical response and a good safety profile as an antifungal agent in patients with varied underlying conditions.

欧洲异黄酮唑实际使用的有效性、安全性和模式(2015-2019 年)。
导言:为了更好地了解异黄酮唑在欧洲实际应用中的作用和表现,需要从多国观察研究中获得真实世界的数据:方法:在欧洲的 16 个地点(法国、德国、意大利、西班牙和英国)开展了一项回顾性病历审查。符合条件的病历来自开始使用异武康唑时年龄≥18岁的患者,并且在符合条件期间(2015年10月15日至2019年6月30日)因疑似或确诊侵袭性曲霉菌病(IA)或侵袭性粘孢子菌病(IM)至少接受过一次异武康唑治疗。对数据进行了描述性分析。对成功率、总生存率和发生这些事件的时间进行了描述性分析:共摘录了218名患者(201名,IA;17名,IM)的数据,这些患者接受了异武康唑单药治疗(52%以输液方式开始;46%以口服方式开始)。92名患者(42.2%)接受了伊沙夫康唑作为主要疗法,121名患者(55.5%)接受了挽救疗法(5名患者情况不明)。平均(标准差)年龄为 56.8(15.6)岁,66% 为男性,62% 至少有三种合并症,其中最常见的是血液恶性肿瘤(62%)。第24周时的估计临床反应率为:初治54.5%(95%置信区间[CI],38.2-66.5%),抢救治疗73.5%(95%置信区间[CI],62.7-81.1%)。总体而言,45 名患者(21%)至少出现过一次不良事件 (AE)。37名患者(17%)出现了严重的不良反应,其中7例与异武康唑有关;5名患者(2.3%)因严重的不良反应停止了异武康唑单药治疗。共有137名患者(63%)死亡,其中17人(12.4%)的死亡与他们的侵袭性真菌感染有关,其中11人开始使用伊沙唑作为挽救疗法:这项研究为越来越多的证据增添了新的内容,即无论是作为一线疗法还是在其他抗真菌疗法失败后使用,伊沙武康唑作为抗真菌药物,在患有各种基础疾病的患者中似乎都具有良好的临床反应和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Infectious Diseases and Therapy
Infectious Diseases and Therapy Medicine-Microbiology (medical)
CiteScore
8.60
自引率
1.90%
发文量
136
审稿时长
6 weeks
期刊介绍: Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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