INTRODUCTION: Real-world data from multi-national observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe.
METHODS: A non-interventional retrospective medical record review conducted at 16 sites in Europe (France, Germany, Italy, Spain, United Kingdom). Eligible records were from adult patients with a diagnosis of invasive aspergillosis (IA) or invasive mucormycosis (IM) who received at least 1 dose of isavuconazole during the eligibility period (15 October 2015 to 30 June 2019). Data were descriptively analysed. The Kaplan-Meier method was used to estimate success rates and overall survival.
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 5 patients). Mean (standard deviation) age was 56.8 (15.6) years, 66% were men and 62% had at least 3 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 1 adverse event (AE). Serious AEs were experienced by 37 patients (17%), with 7 related to isavuconazole; 5 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.
CONCLUSION: 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.
