Program Schedule

Health Economic Outcome Analysis of patients randomized in the SECURE Phase III Trial comparing Isavuconazole to Voriconazole for primary treatment of Invasive fungal disease caused by Aspergillus Species or other filamentous Fungi

Session: Poster Abstract Session: Clinical - Clinical Trials
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
  • AS097-14 ID Week Khandelwal pstr tc16 DW crop.pdf (140.7 kB)
  • Background: Invasive aspergillosis (IA) is an emerging clinical problem and remains an important complication especially among immunocompromised patients. IA is associated with significant increases in morbidity, mortality, length of hospitalization stay (LOS) and costs. Case fatality is estimated to be at 60% in immunocompromised populations.  Despite improved treatment options and advances in diagnostic testing, patient outcomes remain suboptimal. The SECURE trial was a Phase III, double blind, randomized, multi-center, non-inferiority, study of Isavuconazole (ISA) versus Voriconazole (VRC). Patients >18 years of age, who had proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi were randomized 1:1 to receive ISA or VRC. 

    Methods: Primary objective of this analysis was to compare initial LOS during hospitalization and 30-day all-cause hospital readmission rates in patients who received ISA or VRC. Outcomes in subgroups of interest by age, Body Mass Index (BMI) and renally impaired patients (eGFR-MDRD category <60) were conducted. Ratio of total days on IV over total number of days of (IV+oral) therapy for study drugs and total number of additional days on potentially mould-active systemic antifungal therapy after end of study treatment were also analyzed.

    Results: A total of 516 patients were included in the Intent-to-Treat (ITT) group.  Median LOS days was found to be lower for ISA compared to VRC patients (13.0 vs 15.0). The 30-day readmission rate was lower for ISA compared to VRC patients (18.3% vs 24.4%, p=0.114). Ratio of days on IV formulation to total days of (IV+oral) therapy were similar (ISA 0.38 (SD 0.39); VRC 0.38 SD (0.38)). Median additional days on potentially mould-active systemic antifungal therapy were comparable ISA vs VRC (32.0 vs. 33.0). Median LOS days were similar across various subgroups (Figure 1), except in renal impaired subgroup where the difference was statistically significant in favor of ISA (ISA 9.0; VRC 19.0, p=0.0032)

    Conclusion: Health economic analyses in the SECURE trial favored ISA compared to VRC in median LOS days and 30-day readmission rates which were found to be lower with statistically significant difference in LOS in patients with renal impairment.

    Nikhil Khandelwal, PharmD1, Billy Franks, PhD2, Fei Shi1, James Spalding, PharmD3,4 and Nkechi Azie, MD2, (1)Astellas Pharma Scientific and Medical Affairs, Inc, Northbrook, IL, (2)Astellas Scientific and Medical Affairs, Inc., Northbrook, IL, (3)Astellas Pharma US, Inc., Deerfield, IL, (4)Astellas Pharma US, Inc., Northbrook, IL


    N. Khandelwal, Astellas: Employee, Salary

    B. Franks, Astellas: Employee, Salary

    F. Shi, Astellas: Employee, Salary

    J. Spalding, Astellas: Employee, Salary

    N. Azie, Astellas: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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