Clinical Efficacy of Benralizumab in Patients with Severe, Uncontrolled Eosinophilic Asthma and Nasal Polyposis: Pooled Analysis of the SIROCCO and CALIMA Trials

Introduction Nasal polyposis (NP) has been associated with an eosinophilic asthma phenotype and may predict benralizumabʼs efficacy.

Methods This was a post-hoc pooled analysis of the Phase III SIROCCO (48 weeks; NCT01928771; Lancet. 2016;388 : 2115 – 27) and CALIMA (56 weeks; NCT01914757; Lancet. 2016;388 : 2128 – 41) trials. Patients aged ≥ 12 years receiving high-dosage inhaled corticosteroids/long-acting β₂ -agonists with baseline blood eosinophils ≥ 300 cells/µL received benralizumab 30 mg subcutaneously every 8 weeks (Q8W; n = 506) or placebo (n = 515).

Results Patients with NP (NP+) generally had greater mean blood eosinophil counts (Q8W: 668 cells/µL; placebo: 749 cells/µL) than patients without NP (NP ⁻; Q8W: 606 cells/µL; placebo: 597 cells/µL). Baseline maintenance oral corticosteroid use was also greater for NP+ (Q8W: 31.3%; placebo: 21.4%) than for NP ⁻ (Q8W: 10.5%; placebo: 10.1%). Placebo exacerbation rates during treatment were 1.27 (n = 515), 1.74 (n = 117), and 1.13 (n = 398) for the overall, NP+, and NP– groups, respectively. Compared with placebo, benralizumab Q8W reduced exacerbation rates by 42% for all patients (rate ratio [RR], 0.58 [95% confidence interval {CI}, 0.48 – 0.70], p < 0.001; n = 506), by 54% for NP+ (RR, 0.46 [95% CI, 0.31 – 0.69], p < 0.001; n = 115), and by 38% for NP– (RR, 0.62 [95% CI, 0.50 – 0.78], p < 0.001; n = 391). In addition, benralizumab Q8W increased prebronchodilator forced expiratory volume in 1 second by 0.128 L for all patients (95% CI, 0.064 – 0.191, p < 0.001; n = 502), by 0.272 L for NP+ (95% CI, 0.124 – 0.421, p < 0.001; n = 115), and by 0.102 L for NP ⁻ (95% CI, 0.032 – 0.172, p = 0.004; n = 387). Similar trends were observed for asthma symptoms (Asthma Control Questionnaire-6) and asthma-related quality of life (Standardized Asthma Quality of Life Questionnaire for 12 years and older).

Conclusion Benralizumab demonstrated enhanced clinical efficacy for patients with severe, uncontrolled eosinophilic asthma and nasal polyposis.