Clinical Efficacy Of Benralizumab In Patients With Severe, Uncontrolled Eosinophilic Asthma And Nasal Polyposis: Pooled Analysis Of The Sirocco And Calima Trials

Nasal polyposis (NP) has been associated with an eosinophilic asthma phenotype and may predict benralizumab’s efficacy. Post-hoc pooled analysis of the Phase III SIROCCO (48 weeks; Lancet. 2016;388:2115–27) and CALIMA (56 weeks; Lancet. 2016;388:2128–41) trials. Patients aged ≥12 years receiving high-dosage ICS/LABA with baseline blood eosinophils ≥300 cells/μL received benralizumab 30 mg SC every 8 weeks (Q8W; n=506) or placebo (n=515). 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 OCS use was also greater for NP+ (Q8W: 31.3%; placebo: 21.4%) than 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% 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); and increased prebronchodilator FEV1 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 efficacy measures of asthma symptoms (ACQ-6) and asthma-related quality of life (AQLQ[S]+12). Benralizumab demonstrated enhanced clinical efficacy for patients with severe, uncontrolled eosinophilic asthma and NP.