Introduction

Levofloxacin inhalation solution (Quinsair®) is approved in adult patients with cystic fibrosis (CF), and EMA has requested the collection of long-term safety data. 

Objective

To evaluate the safety profile of levofloxacin inhalation solution (LIS) 240mg twice daily compared to other inhaled approved antibiotic therapies in patients with CF.

Methods

Interim data up to 2020 of a PASS of LIS including patients enrolled in the UK and German (DE) CF registries, over five (2017-2021) and three years (2019-2021), respectively, were analysed. Propensity score models in adult patients were used to compare the LIS to the non-LIS (NLIS) cohort taking other inhaled antibiotics. Primary endpoints included occurrence of haemoptysis, liver disease and tendon rupture.

Results

In the UK, 91 and 451 adult patients were included in the LIS and NLIS cohorts, respectively; in DE, equivalent numbers were 491 and 1809. In the UK, less than 5 patients had haemoptysis in the LIS cohort, compared with 54 (12%) in the NLIS cohort (relative risk (RR): 0.09, 95%CI 0.01-0.65), with the former figures limiting meaningful comparison. In DE, a non-significantly higher risk of haemoptysis was observed in the LIS cohort (7% vs 3%, RR: 1.45, 0.98-2.15) with a significantly higher rate in the LIS cohort (rate ratio: 1.95, 1.41-2.69). Risk of liver disease was similar for LIS and NLIS cohorts: RR 1.00 (0.57-1.76) in the UK (18% in both cohorts) and 0.85 (0.53-1.36) in DE (5% in both cohorts). Tendon rupture only occurred in DE (<5 patients in LIS and NLIS cohorts).

Conclusions

Interim results suggest that the safety profile of LIS is comparable to other inhaled antibiotics.