Analyses of FLAME trial show Ultibro Breezhaler superior to Seretide for COPD regardless of eosinophil count.- Novartis

Further analyses of Novartis' head-to-head FLAME study suggest that inhaled corticosteroids (ICS) may not be needed in some chronic obstructive pulmonary disease (COPD) patients with high blood eosinophil (a type of white blood cell) counts. The new data showed that Ultibro Breezhaler consistently provided superior or similar benefits over Seretide in COPD patients regardless of the eosinophil count. These results contrast with data suggesting better clinical outcomes with ICS therapies for patients with high eosinophil counts. The data was published in the centenary issue of the American Thoracic Society's 'Blue Journal' and solidifies the need for individualized risk-benefit assessments when considering ICS treatments.

The potential for high blood eosinophil counts to be considered as a biomarker to direct the use of a LABA/ICS combination over dual bronchodilation (LABA/LAMA in some patients, has been referenced in the 2017 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report. FLAME was the first trial to prospectively study the influence of blood eosinophils on the efficacy of ICS-containing therapies versus a LABA/LAMA.

The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%. In addition, at no cut-off was Seretide more effective than Ultibro Breezhaler.

With funding support from Novartis, the International Primary Care Respiratory Group (IPCRG) is addressing the appropriate use and safe withdrawal of ICS in COPD patients with the launch of a primary care physician guide. The guide was launched at the recent IPCRG conference in Slovenia and aims to ensure the latest evidence based treatment guidance from the 2017 GOLD report is translated into daily clinical practice. The guide is accessible on the IPCRG website here: https://goo.gl/FlSVck.

See- Roche N, Chapman K, Vogelmeier C, et al. "Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial"-. Am J Respir Crit Care Med. 2017;195:9:1125-1127.

See- Wedzicha JA, Banerji D, Chapman KR, et al. "Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD"-. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385.