Raptor Pharmaceutical Corp., a biopharmaceutical company developing and commercializing transformative treatments for rare diseases, presented results from a network meta-analysis comparing inhaled antibiotics for cystic fibrosis (CF) patients with lung infections involving Pseudomonas aeruginosa. The study showed that Quinsair, a levofloxacin inhalation solution, had efficacy comparable to three other inhalable antibiotics also approved for use in Europe. These data were presented at the European Respiratory Society (ERS) International Congress 2016 in London.
"Chronic P. aeruginosa lung infection is the primary cause of progressive lung function decline in patients with CF, and long-term maintenance therapy with inhaled antibiotics is recommended to suppress infection, reduce acute pulmonary exacerbations and preserve lung function," said Stuart Elborn, M.D., Professor of Respiratory Medicine in Queen's University and Director of the Adult CF Centre at Belfast City Hospital. "As patients with CF with chronic P. aeruginosa infections frequently require changes in treatment, the availability of levofloxacin provides a useful option to preserve respiratory function over a longer period of time."
Utilizing a systematic literature search, the network meta-analyses leveraged data from all randomized clinical trials of inhaled antibiotics in CF patients with at least 4 or 24 weeks of follow-up, and compared the effect of inhaled antibiotics tobramycin, colistimethate sodium, aztreonam and levofloxacin against P. aeruginosa infections. Of the 685 articles identified, 7 and 9 unique studies were included in the 4 weeks and 24 weeks analysis, respectively.
Aztreonam, dosed at 75 mg three times daily, was predicted to result in the greatest numerical increase in forced expiratory volume in 1 second (FEV1%) at 4 weeks, while levofloxacin inhalation solution was predicted to be numerically greater than colistimethate sodium, tobramycin inhaled solution and tobramycin inhaled powder. The analyses for many of the outcomes did not provide evidence to indicate that the other treatments were more effective than levofloxacin. At 24 weeks, levofloxacin inhalation solution was associated with the lowest risk of hospitalization with a 96.5% of probability to be the best treatment. P. aeruginosa sputum density scores, additional antipseudomonal antibiotics use, and study withdrawal rates were comparable among all inhaled antibiotics at all times.
"This network meta-analysis suggests that inhaled levofloxacin provides a useful addition to our armory in the fight against this common and difficult to treat infection," said Krishna R. Polu, M.D., chief medical officer of Raptor. "Given the chronicity and reduction in survival caused by P. aeruginosa infection in CF, the availability of inhaled levofloxacin is an important option for clinicians to maintain lung function in CF patients and an important step in tackling the unmet need in the CF community."
