BACKGROUND: Although real-world studies have reported the effectiveness of isavuconazole against invasive aspergillosis (IA), comprehensive real-world data examining treatment characteristics, effectiveness, and safety of isavuconazole against IA are needed. Objectives: To describe the effectiveness and safety of monotherapy isavuconazole, and to determine the patterns of use of isavuconazole in real-world clinical practice. RESULTS: Of the 229 IA patients enrolled, 179 (78%) were treated with isavuconazole monotherapy (intravenous and/or oral); 22% were treated with combination therapy. Among patients receiving monotherapy, mean (standard deviation) age was 55.7 (15.6) years, 69% were men and 61% had at least 3 comorbidities, with hematologic malignancy the most frequent (60%). Invasive aspergillosis was localized in the lungs in 96% of cases. Isavuconazole was administered as first-line for 25%, second-line for 45%, third-line for 20%, and at least fourth-line for 10%. Most frequently prescribed prior antifungals were voriconazole (41%), posaconazole (24%) and liposomal amphotericin B (24%). Estimated clinical success rate at week 24 following isavuconazole initiation was 64% (95% CI = 54.1, 72.0). Overall, 41 patients (23%) experienced at least one adverse event (AE) while on monotherapy treatment. Serious AEs were experienced by 33 patients (18%), with 4 related to isavuconazole (n=2 hepatobiliary; n=1 myopathy; n=1 septic shock and organ failure); 3 patients (2%) discontinued isavuconazole monotherapy due to serious AEs. A total of 115 patients (64%) died, with 11 deaths (10%) related to IA. CONCLUSION: This study provides important real-world evidence on effectiveness, safety, and patterns of use of isavuconazole in clinical practice in Europe. Isavuconazole is one of the antifungals recommended for treatment of IA.
METHODS: A non-interventional retrospective medical record review conducted at 16 sites in Europe (France, Germany, Italy, Spain, UK). Eligible records were from patients aged ≥ 18 years at isavuconazole initiation, with a record of IA diagnosis (suspected or confirmed), who received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019). Data were descriptively analysed. The Kaplan-Meier method was used to estimate success rates.
