Raptor Shows Quinsair Comparable in Cystic Fibrosis Patients to Other Inhaled Antibiotics

Daniela Semedo, PhD avatar

by Daniela Semedo, PhD |

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Cystic fibrosis survey

Raptor Pharmaceuticals recently presented the results of a meta-analysis comparing the effectiveness of inhaled antibiotics for cystic fibrosis (CF) patients and Pseudomonas aeruginosa lung infections. The results, presented in London at the 2016 International Congress of the European Respiratory Society (ERS), showed that the company’s levofloxacin inhalation solution Quinsair was comparable in effectiveness to three other European-approved inhalable antibiotics.

CF is a rare, life-threatening genetic disease that causes persistent lung infections due to the buildup of thick, sticky mucus which progressively limits the patient’s ability to breath. The lung infections are mostly caused by bacteria, with 75 percent of cystic fibrosis patients experiencing chronic P. aeruginosa infections.

Quinsair is approved in the E.U. and in Canada for the management of chronic pulmonary infections due to P. aeruginosa in adult patients with cystic fibrosis.

“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,” Dr. Stuart Elborn, MD, professor of respiratory medicine at Queen’s University and director of the Adult CF Centre at Belfast City Hospital, said in a press release.

“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.”

The meta-analysis included all randomized clinical trials assessing the use of inhaled antibiotics in CF patients with follow-ups of four or 24 weeks. It compared the effectiveness of aztreonam, tobramycin, colistimethate sodium, and Quinsair against lung infections involving P. aeruginosa. A total of 685 articles were retrieved and of these, seven studies were included in the four-week analysis and nine studies were included in the 24-week analysis.

Treatment with aztreonam (75 mg) three times daily was found to result in the greatest increase in forced expiratory volume in 1 second (FEV1%; a measure of lung function) at four weeks. But Quinsair (levofloxacin) was found to be superior to colistimethate sodium, tobramycin inhaled powder and tobramycin inhaled solution.

The results showed there was no evidence indicating that the other solutions were more effective than Quinsair. Results from the 24-week analysis demonstrated that the inhalation solution Quinsair was linked to the lowest hospitalization risk, with a 96.5 percent of probability to be the most appropriate treatment option. The analysis of P. aeruginosa sputum density scores, use of additional antibiotics against P. aeruginosa, as well as the study of withdrawal rates, were similar 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 Dr. Krishna R. Polu, MD, Raptor’s chief medical officer. “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.”