PT - JOURNAL ARTICLE AU - Mario Castro AU - Sally Wenzel AU - Roland Kolbeck AU - Deepak Khatry AU - Ward Christine AU - Yanping Wu AU - Rene van der Merwe AU - Eugene Bleecker TI - Late-breaking abstract: A phase 2 study of benralizumab on exacerbations, lung function, and asthma control in adults with uncontrolled eosinophilic asthma DP - 2014 Sep 01 TA - European Respiratory Journal PG - 2909 VI - 44 IP - Suppl 58 4099 - http://erj.ersjournals.com/content/44/Suppl_58/2909.short 4100 - http://erj.ersjournals.com/content/44/Suppl_58/2909.full SO - Eur Respir J2014 Sep 01; 44 AB - OBJECTIVE: Benralizumab is an anti-interleukin-5 receptor α monoclonal antibody that depletes blood and airway eosinophils. This was a double-blind phase 2 study (NCT01238861) of benralizumab in adults with uncontrolled asthma, using medium/high dose inhaled corticosteroid (ICS)/long-acting beta agonists, with ≥2 exacerbations in the past year.METHODS: Stratification was by eosinophil phenotype (determined by blood count-based algorithm or FeNO >50 ppb) and baseline ICS use (medium/high). Subjects received placebo (PBO) or benralizumab 2, 20, or 100 mg (eosinophilic); or PBO or benralizumab 100 mg (non-eosinophilic). Primary endpoint was annual exacerbation rate (AER) at week 52 (eosinophilic only). Secondary endpoints were FEV1, ACQ6, and safety. The study was designed with a two-sided α=0.2.RESULTS: The mITT population (N=606) was 69% female; mean (SD) age 48 (12) years; ACQ6 2.58 (0.91); FEV1 % predicted 66.5 (15.1); 5% chronic oral corticosteroid use. AER was reduced by 41% for eosinophilic benralizumab 100 mg (n=80) vs PBO (n=82, p=0.096). Improvements in FEV1 and ACQ6 (all doses and groups) were statistically significant vs PBO. In a pre-specified subgroup analysis by blood eosinophils, benralizumab 100 mg reduced the AER by 43% (n=97, PBO n=83, p=0.049) and 70% (n=58, PBO n=52, p=0.002) for ≥300 and ≥400 cells/µL groups, respectively. Most frequent adverse events by week 66 for PBO and benralizumab were nasopharyngitis (5.9%, 11.4%) and headache (7.2%, 9.4%).CONCLUSIONS: Benralizumab reduced asthma exacerbations and improved FEV1 and ACQ6 in adults with uncontrolled eosinophilic asthma and has promise as a novel therapy in this population.