Safety of inhaled levofloxacin in people with cystic fibrosis: Data from UK and German Registries.

BACKGROUND

Levofloxacin inhalation solution (LIS) is approved for managing chronic Pseudomonas aeruginosa infections in adult patients with cystic fibrosis (CF). The European Medicines Agency made a provisional marketing authorisation of LIS conditional on its long-term safety evaluation in clinical practice.

METHODS

The safety of LIS was evaluated using data from the UK (2017-2021) and German CF Registries (2019-2021). Propensity score models were used to compare the LIS cohorts (patients treated with LIS at any time during observation) with the non-LIS cohorts (treated with other inhaled antibiotics). Primary endpoints included haemoptysis, liver disease, tendon rupture, antimicrobial resistance and treatment discontinuation.

RESULTS

In the UK Registry, 103 and 511 adult patients were included in the LIS and non-LIS cohorts, respectively. In the German Registry, equivalent numbers were 524 and 1893. In the UK, no significant difference in haemoptysis rates was observed between the LIS and non-LIS cohorts (17.5% vs 19.6%, adjusted relative risk [aRR]: 0.88, 95%CI 0.56-1.39, P=0.583). In the German Registry, a higher risk of haemoptysis was observed in the LIS cohort (17% vs 12%; aRR: 1.30, 95%CI 1.06-1.59, P=0.012). There was no increased risk of liver disease associated with LIS treatment, and tendon ruptures were rare. Antimicrobial resistance patterns were similar in LIS and non-LIS cohorts, and treatment discontinuation due to adverse events was low in both registries.

CONCLUSIONS

LIS was generally safe although may be associated with a higher risk of haemoptysis. No difference in liver disease, tendon rupture or treatment discontinuation compared to other inhaled antibiotics was observed.