Efficacy and Safety of Isavuconazole for Invasive Fungal Infections: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background: Isavuconazole (ISA) is a treatment option for invasive fungal infections (IFIs) and is known for a favorable safety profile compared with other antifungal agents. However, comprehensive evidence regarding its efficacy and safety remains limited.

Objectives: This study aimed to assess the efficacy and safety of ISA compared with other antifungal agents through a systematic review and meta-analysis restricted to randomized controlled trials (RCTs), to provide more reliable estimates of its clinical effects.

Methods: Following PRISMA guidelines, a comprehensive literature search was conducted using PubMed, the Cochrane Library, Web of Science, and ClinicalTrials.gov to identify RCTs comparing ISA with other antifungal agents. The primary outcomes were clinical response and mortality. Secondary outcomes included the incidence of adverse events, including serious, drug-related, and organ-specific toxicities. A subgroup analysis was conducted focusing on filamentous fungal infections, comparing ISA and voriconazole.

Results: Three RCTs met the inclusion criteria. No statistically significant differences were observed between ISA and comparator agents in terms of clinical response, mortality, or total and organ-specific adverse events. A trend toward fewer adverse events was noted in the ISA group. In the subgroup analysis, ISA and voriconazole showed similar efficacy and overall safety; however, the incidence of both drug-related adverse events and hepatobiliary disorders was significantly lower in the ISA group.

Conclusions: ISA demonstrated efficacy comparable to that of other antifungal agents, with a favorable safety profile in patients with IFIs, including filamentous fungal infections. This meta-analysis of RCTs provide high-quality evidence to support antifungal drug selection in clinical practice.