Typically, clinical trials of biologics in severe asthma (SA) do not include patients (pts) with FEV1 ?80%, who might be responsive to treatment.

Aims and objectives

To characterize pts in the ORBE II study and assess clinical outcomes after 12 months of treatment with benralizumab, according to their baseline FEV1 (%).


ORBE II (NTC04648839) is a retrospective multicenter study conducted in SA pts treated with benralizumab in clinical practice in Spain. For this analysis, pts were split into 3 groups according to their baseline FEV1 (?80%, <80%, and <60%).


Pts with FEV1 ?80% have a shorter asthma duration, but similar smoking habits and prior biologic use than those with lower FEV1. After 12 months of treatment, improvements in exacerbations and asthma control were similar among groups. Pts with initial FEV1 <80% had greater improvements in lung function; in those with FEV1 <60%, improvements were more modest.


Clinical and lung function improvements can be achieved with benralizumab regardless of initial lung function, even in patients with FEV1 ?80%.