Daliresp roflumilast: Phase III/IV data

The 1-year, double-blind, international Phase III/IV REACT trial in 1,945 patients showed that 500 µg daily oral Daxas plus a long-acting beta 2 agonist (LABA) and an inhaled corticosteroid (ICS) with or without a long-acting muscarinic antagonist (LAMA) reduced the rate of moderate to severe exacerbations, the primary endpoint, by 13.2% using a Poisson regression analysis (p=0.0529) and by 14.2% using a predefined negative binomial regression sensitivity analysis (p=0.0424) compared to placebo plus a LABA and ICS with or without a LAMA. Patients in the Daxas arm experienced a 56 mL increase in post-bronchodilator FEV1 (p<0.0001) and a 92 mL increase in FVC compared to the placebo arm. Furthermore, the Daxas-based combination reduced the rate of severe exacerbations by 24.3% and the rate of exacerbations requiring hospitalization by 23.9% vs. placebo (p=0.0175 and p=0.0209, respectively). The most frequently reported serious adverse events were exacerbations and pneumonia. There were 17 deaths in the Daxas arm and 18 in the placebo arm. The trial enrolled COPD patients ages >=40 with a smoking history of >=20 pack-years. Data were published in The Lancet. ...