Clinical experience with isavuconazole in healthy volunteers and patients with invasive aspergillosis in China, and the results from an exposure–response analysis.

Background: Isavuconazole is a broad‐spectrum triazole for the treatment of invasive fungal disease (IFD). Objective: To investigate the clinical experience with isavuconazole in Chinese individuals. Patients/Methods: Participants were Chinese healthy volunteers from a Phase I pharmacokinetics (PK) and safety study of single/multiple doses of isavuconazole (n = 36) and Chinese patients from the global Phase III SECURE study that assessed safety and efficacy of isavuconazole vs voriconazole for IFD treatment (n = 26). Results: No clinically relevant differences in PK were found between Chinese and Western participants, although exposure was increased in Chinese volunteers. Treatment‐emergent adverse events (TEAEs) were reported in 75.0% of healthy volunteers, many of which were infusion‐related. No serious AEs were reported. In SECURE, findings in Chinese patients (n = 26) were similar to the global population. For patients who received ≥1 dose of study drug, allcause mortality from first dose to Day 42 was 10.0% (1/10) with isavuconazole and 25.0% (4/16) with voriconazole (treatment difference [95% confidence interval, CI]: −15.0% [−43.2%, 13.2%]). Overall response at the end of treatment for patients with proven/probable IFD was 25.0% and 16.7% with isavuconazole and voriconazole, respectively (treatment difference [95% CI] −8.3% [−60.2%, 43.5%]). Isavuconazole was associated with lower incidence of hepatobiliary, eye, skin, subcutaneous tissue and psychiatric disorders compared with voriconazole and lower incidence of treatment‐related TEAEs, serious TEAES or death overall. Conclusions: Although further research is required, this study demonstrated a favourable risk–benefit profile of isavuconazole in Chinese patients. [ABSTRACT FROM AUTHOR]