The current studies named Galathea & Terranova aimed to determine the efficacy and safety of benralizumab, an interleukin-5 receptor alpha–directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In a randomized trial, patients were assigned at a ratio 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. <220 per cubic millimeter]) to receive either Benralizumab at different doses (30 or 100 mg in GALATHEA; 10, 30, or 100 mg in TERRANOVA) every 8 weeks (every 4 weeks for the first three doses) or placebo. In both studies benralizumab compared to placebo failed to decrease the annual rate of exacerbations. No significant differences were observed in regard to adverse events. In conclusion a biologic targeting IL-5 receptor is safe but failed to provide significant differences in regard to annual rate of exacerbations in patients with moderate to severe COPD who had frequent exacerbations despite receiving guideline-based inhaled treatment.
###Comment
This is the third negative study for biologics in COPD. The last years there was an increased recognition for the role of T2 related process and particularly eosinophils in COPD. However, any intervention relating to the above processes failed to show similar benefits to those observed in asthma. Three are the important points. The selection of patients, the resistant eosinophil and the stratification process. Do we require further investigation and in which direction? Possibly yes. Selecting patients not treated with ICS, stratified them by a higher number of blood eosinophils and last but not least selecting the right target for different groups.