Isavuconazole Versus Voriconazole as the First-line Therapy for Solid Organ Transplant Recipients With Invasive Aspergillosis: Comparative Analysis of 2 Multicenter Cohort Studies.
Mario Fernández-Ruiz, Francesca Gioia, Marta Bodro, Isabel Gutiérrez Martín, Núria Sabé, Regino Rodriguez-Álvarez, Laura Corbella, Teresa López-Viñau, Maricela Valerio, Aitziber Illaro, Sonsoles Salto-Alejandre, Elisa Cordero, Francisco Arnaiz de Las Revillas, María Carmen Fariñas, Patricia Muñoz, Elisa Vidal, Jordi Carratalà, Josune Goikoetxea, Antonio Ramos-Martínez, Asunción Moreno, Pilar Martín-Dávila, Jesús Fortún, José María Aguado
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引用次数: 0
Abstract
Background: Isavuconazole (ISA) and voriconazole (VORI) are recommended as the first-line treatment for invasive aspergillosis (IA). Despite theoretical advantages of ISA, both triazole agents have not been compared in solid organ transplant recipients.
Methods: We performed a post hoc analysis of 2 retrospective multicenter cohorts of solid organ transplant recipients with invasive fungal disease (the SOTIS [Solid Organ Transplantation and ISavuconazole] and DiasperSOT [DIagnosis of ASPERgillosis in Solid Organ Transplantation] studies). We selected adult patients with proven/probable IA that were treated for ≥48 h with ISA (n = 57) or VORI (n = 77) as first-line therapy, either in monotherapy or combination regimen. The primary outcome was the rate of clinical response at 12 wk from the initiation of therapy. Secondary outcomes comprised 12-wk all-cause and IA-attributable mortality and the rates of treatment-emergent adverse events and premature treatment discontinuation.
Results: Both groups were comparable in their demographics and major clinical and treatment-related variables. There were no differences in the rate of 12-wk clinical response between the ISA and VORI groups (59.6% versus 59.7%, respectively; odds ratio [OR], 0.99; 95% confidence interval [CI], 0.49-2.00). This result was confirmed after propensity score adjustment (OR, 0.81; 95% CI, 0.32-2.05) and matching (OR, 0.79; 95% CI, 0.31-2.04). All-cause and IA-attributable mortality were also similar. Patients in the ISA group were less likely to experience treatment-emergent adverse events (17.5% versus 37.7%; P = 0.011) and premature treatment discontinuation (8.8% versus 23.4%; P = 0.027).
Conclusions: Front-line treatment with ISA for posttransplant IA led to similar clinical outcomes than VORI, with better tolerability and higher treatment completion.
背景：异武唑（ISA）和伏立康唑（VORI）被推荐为侵袭性曲霉菌病（IA）的一线治疗药物。尽管 ISA 具有理论上的优势，但这两种三唑类药物尚未在实体器官移植受者中进行过比较：我们对两组患有侵袭性真菌病的实体器官移植受者的回顾性多中心队列（SOTIS [Solid Organ Transplantation and ISavuconazole] 和 DiasperSOT [DIagnosis of ASPERgillosis in Solid Organ Transplantation] 研究）进行了事后分析。我们选择了经证实/可能患有IA的成年患者，这些患者接受ISA（57人）或VORI（77人）治疗≥48小时，作为单药或联合疗法的一线治疗。主要结果是治疗开始 12 周后的临床应答率。次要结果包括 12 周内的全因死亡率和可归因于 IA 的死亡率，以及治疗引发的不良事件发生率和过早中断治疗的发生率：两组在人口统计学、主要临床和治疗相关变量方面具有可比性。ISA组和VORI组的12周临床反应率没有差异（分别为59.6%和59.7%；几率比[OR]，0.99；95%置信区间[CI]，0.49-2.00）。这一结果在倾向得分调整（OR，0.81；95% CI，0.32-2.05）和匹配（OR，0.79；95% CI，0.31-2.04）后得到了证实。全因死亡率和可归因于ISA的死亡率也相似。ISA组患者发生治疗突发不良事件（17.5%对37.7%；P = 0.011）和过早中断治疗（8.8%对23.4%；P = 0.027）的可能性较小：ISA治疗移植后IA的一线治疗与VORI的临床结果相似，耐受性更好，治疗完成率更高。
期刊介绍：
The official journal of The Transplantation Society, and the International Liver Transplantation Society, Transplantation is published monthly and is the most cited and influential journal in the field, with more than 25,000 citations per year.
Transplantation has been the trusted source for extensive and timely coverage of the most important advances in transplantation for over 50 years. The Editors and Editorial Board are an international group of research and clinical leaders that includes many pioneers of the field, representing a diverse range of areas of expertise. This capable editorial team provides thoughtful and thorough peer review, and delivers rapid, careful and insightful editorial evaluation of all manuscripts submitted to the journal.
Transplantation is committed to rapid review and publication. The journal remains competitive with a time to first decision of fewer than 21 days. Transplantation was the first in the field to offer CME credit to its peer reviewers for reviews completed.
The journal publishes original research articles in original clinical science and original basic science. Short reports bring attention to research at the forefront of the field. Other areas covered include cell therapy and islet transplantation, immunobiology and genomics, and xenotransplantation.
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