Effectiveness and Tolerability of Micafungin in Chinese Patients with Invasive Fungal Infections: A Retrospective, Multicenter Study

Abstract

Introduction: Invasive fungal infections (IFIs) are a significant health problem in immunocompromised patients, resulting in substantial morbidity, mortality, and healthcare costs. Micafungin is a broad-spectrum echinocandin with activity against Candida and Aspergillus spp. This was a multicenter, non-comparative, retrospective observational study that evaluated the effectiveness and tolerability of intravenously administered micafungin for treating IFIs caused by Candida and Aspergillus spp.

Methods: Adult patients in China who had received at least one dose of intravenously administered micafungin were eligible. Retrospective data (May 2008-April 2015) were extracted from patients' medical files and recorded using electronic data capture. The primary endpoint was overall success rate (patients with complete or partial response). Subgroup analyses determined effectiveness according to diagnostic certainty, fungal species, type of IFI, duration of micafungin treatment, and daily dose of micafungin. Tolerability, including the incidence of adverse events (AEs), was also assessed.

Results: Overall, 2555 patients who received at least one dose of micafungin were identified. The mean duration of treatment and mean daily dose were 10.2 days and 133.0 mg, respectively. The overall success rate was 60.8%; this was significantly higher in patients who received treatment for at least 1 week (range 67.9-71.6% [mean 69.2%]) compared with less than 1 week (47.8%; P < 0.0001), and those who received 50-100 mg (65.7%) compared with other daily doses (range 42.9-60.1% [mean 59.0%]; P = 0.0011). Success rates in Candida- and Aspergillus-infected patients were similar (61.9% and 56.8%, respectively). AEs and adverse drug reactions were observed in 36.2% and 4.5% of patients, respectively. The majority of AEs were mild, while discontinuation due to AEs was low (2.3%).

Conclusion: Micafungin is effective and well tolerated for the treatment of patients with IFIs in China, as demonstrated in Candida- and Aspergillus-infected adults. Subgroup analyses highlighted the potential benefits of treating IFIs with micafungin for a minimum of 1 week.

Trial registration: ClinicalTrials.gov identifier NCT02678598.

Funding: Astellas Pharma Inc.

Keywords: Aspergillus; Candida; Invasive fungal infections; Micafungin; Real-world data; Retrospective study.

Figures

Fig. 1

Patient disposition. FAS full analysis set, IFI invasive fungal infection, PPS per-protocol set, SAS safety analysis set

Fig. 2

Overall success rates (proportion of patients with complete or partial response) at the end of treatment according to diagnostic certainty (a); the organism causing the infection (b); type of disease (c); treatment duration (d); and the daily dose (e) in the FAS. P values indicate significant differences between treatment groups (providing there is also a clear difference in the proportion of patients with a complete or partial response); error bars represent asymptotic 95% confidence intervals. FAS full analysis set