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

Area of Science:

• Mycology
• Infectious Diseases
• Clinical Pharmacology

Background:

• Real-world data on isavuconazole use in Europe is needed to assess its clinical performance.
• Understanding isavuconazole's role in treating invasive fungal infections (IFIs) like invasive aspergillosis (IA) and invasive mucormycosis (IM) is crucial.

Purpose of the Study:

• To evaluate the real-world effectiveness and safety of isavuconazole in European patients.
• To analyze clinical response rates, overall survival, and adverse events associated with isavuconazole treatment for IA and IM.

Main Methods:

• Retrospective medical record review of 218 patients across 16 European sites.
• Inclusion criteria: patients aged ≥18 years receiving at least one dose of isavuconazole for suspected/confirmed IA or IM between October 2015 and June 2019.
• Descriptive analysis of clinical response, survival, and adverse events.

Main Results:

• Isavuconazole was used as monotherapy in 218 patients (201 IA, 17 IM), initiated as primary (42.2%) or salvage (55.5%) therapy.
• Estimated clinical response at week 24 was 54.5% for primary and 73.5% for salvage therapy.
• Adverse events (AEs) occurred in 21% of patients; serious AEs in 17%, with 2.3% discontinuing due to serious AEs. Overall mortality was 63%.

Conclusions:

• Isavuconazole shows a promising clinical response and a good safety profile in real-world European practice.
• The study supports isavuconazole's efficacy as both first-line and salvage therapy for invasive aspergillosis and invasive mucormycosis.
• Findings contribute to the evidence base for isavuconazole's utility in diverse patient populations with serious fungal infections.