According to clinical guidelines and consensus, the main goals of severe asthma management with biologics include controlling asthma symptoms and improving lung function.

ORBE II (NTC04648839) is a retrospective multicenter study, being conducted in severe asthma patients treated with benralizumab in Spain. The study is part of XALOC, an international program that aims at analyzing characteristics and clinical outcomes of patients treated with benralizumab in routine clinical practice conditions.

The results presented below describe baseline and follow-up data on asthma control and lung function in the ORBE II study, according to relevant thresholds, after one year of treatment. Asthma control was measured by Asthma Control Test (ACT) and lung function by percentage of predicted pre-bronchodilator (BD) FEV1. Baseline data were assessed 12 months prior to the start of benralizumab treatment (last available measure).

ORBE II included 204 evaluable patients (overall population), out of which 75 (36.8%) also had comorbid chronic rhinosinusitis with nasal polyps (CRSwNP). At baseline, mean (standard deviation, SD) ACT score was 14.1 (5.1), and mean (SD) percentage of predicted FEV1 was 67.3 (21.0). At 12 months of benralizumab treatment, 74% of patients achieved symptom control (ACT≥20), and 47% of patients did not show airflow limitation (FEV1 pre-BD≥80%). Similar or numerically higher results were observed in the CRSwNP subgroup of patients.

In ORBE II study, a majority of patients had relevant improvements in ACT and achieved symptoms control. Clinically meaningful improvements in lung function were also observed. These conclusions also apply to the subgroup of CRSwNP patients.