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

Abstract

IntroductionInvasive 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.MethodsAdult 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.ResultsOverall, 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%).ConclusionMicafungin 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 registrationClinicalTrials.gov identifier NCT02678598.FundingAstellas Pharma Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0762-5) contains supplementary material, which is available to authorized users.

Micafungin for Candida infections in Slovenia and Romania: A multicenter, observational, prospective study

“…However, in the observational study in France, antifungal treatment was only prescribed by hematologists, while in Slovenia, hematologists as well as other specialists, such as ICU doctors, infectologists and pediatricians, who more frequently encounter IC, were involved. Consequently, the population of patients included in M-TREAT from Slovenia and Romania was more consistent with those in other observational studies of micafungin use [17,34].…”

“…Higher doses of 100 mg day −1 and 150 mg day −1 have been used in other studies, including for prophylaxis in neutropenic patients and high-risk liver transplant recipients [42,43]. For treatment, doses administered to adult patients in other hospital-based studies are consistent with the approved and recommended doses and are comparable to those administered here [17,41]. The deviation in treatment duration and dose from the label and associated treatment guidelines in this study reflect the real-world use of micafungin in Slovenia and Romania and may be a consequence of socio-economic factors and clinicians' experience of the treatment of invasive fungal infections in these two countries.…”

“…It is possible that the shorter duration of treatment in both countries is representative of realworld clinical practice; however, other factors, such as the financial burden of treatment on the healthcare systems, cannot be discounted. Studies have reported variation in the duration of micafungin treatment in real-world settings; in a retrospective, observational study of Chinese patients treated for IFIs in a hospital setting, micafungin was administered for a mean treatment duration of 10.2 days [17]. In a real-world study of prophylactic micafungin use in patients with hematological malignancies, the duration of micafungin treatment was consistent with the label from the pharmaceutical laboratory [35], whilst a longer treatment duration has been observed in some studies (25 -36 days) [36,37].…”

“…Guidelines recommend an echinocandin as first-line treatment for IC and esophageal candidiasis, and for prophylaxis in patients at high-risk for Candida infection, including those who are immunocompromised and undergoing HSCT [13][14][15][16]. Micafungin has broad-spectrum anti-fungal activity against Candida species and some Aspergillus species [17], and is approved for the treatment of adults and children (< 16 years) with IC, for the treatment of esophageal candidiasis in adults, and for prophylaxis in patients undergoing allogeneic HSCT and those expected to have neutropenia (absolute neutrophil count < 500 cells/µL) for ≥ 10 days [18] when other antifungals are not appropriate. Micafungin has demonstrated non-inferiority to caspofungin, amphotericin B, fluconazole, and itraconazole in the treatment of IFIs [19,20], and is the only echinocandin approved for antifungal prophylaxis; in clinical trials, micafungin has shown superiority to fluconazole and non-inferiority to itraconazole for fungal prophylaxis [20][21][22].…”

Fungal pneumonia manifesting as cavitary lesions in a critically ill elderly patient

“…His self-care ablity, self-cough ability, and swallowing function were significantly impaired. Long-term treatment with broad-spectrum antibiotics and cachexia caused by malignant tumor greatly increased the opportunity of invasive fungal infection (IFI) [5][6][7]. Elderly patients may exhibit atypical symptoms of pneumonia or the symptoms may be masked by other co-morbid conditions.…”