Novartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts.
The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients regardless of eosiophil count. These results contrast with previous work suggesting better outcomes with inhaled corticosteroids for patients with high eosinophil counts.
Novartis said the data reinforces the need for individualized risk-benefit assessments when physicians consider inhaled corticosteroid regimens for COPD patients.
Flame was the 1st trial to prospectively study the impact that blood eosinophils, a type of white blood cell, have on the efficacy of inhaled corticosteroid therapies compared to dual bronchodilation.
The data showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium 110/50 mcg) was better than twice-daily Seretide (salmeterol/fluticasone 50/500 mcg) at reducing flare-ups in COPD patients, independent of a blood eosinophil count above or below 2%.
“These new Flame study analyses provide evidence that an effective dual bronchodilator such as Ultibro Breezhaler can provide similar or better benefits in patients with high eosinophil counts who may have been considered for an inhaled steroid-containing treatment,” global head of drug development & chief medical officer Vasant Narasimhan said in prepared remarks. “The data highlight the opportunity to allow more patients to avoid unnecessary exposure steroid-containing regimens and the significant potential associated risks.”