Patients Remaining Exacerbation-Free During Benralizumab Treatment Compared With Placebo: Analysis of Pooled Data From the SIROCCO and CALIMA Trials

Introduction Asthma exacerbations disrupt patientsʼ(pts) daily activities and may result in emergency department (ED) visits or hospitalizations. Benralizumab, an anti-eosinophilic monoclonal antibody, significantly reduces asthma exacerbations, improves lung function, and alleviates symptoms in severe, uncontrolled, eosinophilic asthma. We aimed to determine if benralizumab treatment also increases the percentage of exacerbation-free patients relative to placebo (PBO).

Methods We pooled data from 2 Phase III trials, SIROCCO (48 weeks; Lancet. 2016;388 : 2115 – 27) and CALIMA (56 weeks; Lancet. 2016;388 : 2128 – 41). Pts in the pooled population were aged ≥ 12 yrs, received high-dosage ICS/LABA, and had baseline blood eosinophils ≥ 300 cells/µL. In the 2 trials, pts received benralizumab 30 mg Q4W (n = 516), or Q8W (first 3 doses Q4W; n = 506), or PBO (n = 515). This analysis examined overall exacerbations and those requiring ED visits and/or hospitalizations over the course of both trials.

Results More pts were exacerbation-free with benralizumab Q4W (332 pts [64%]) and Q8W (318 pts [63%]) vs. PBO (254 pts [49%]); 98 pts (19%), 115 pts (23%), and 108 pts (21%), respectively, experienced 1 exacerbation. Two or more exacerbations were experienced by 86 (17%), 73 (14%), and 153 (30%) pts, respectively. The mean number of days with exacerbations per yr was also less for benralizumab-treated pts (Q4W: 6.5 days; Q8W: 6.0 days) vs. PBO (11.6 days). Fewer pts in the Q4W and Q8W groups experienced exacerbations requiring ED visits or hospitalizations (44 [9%] and 38 [8%], respectively) than with PBO (57 [11%]).

Conclusion Most benralizumab-treated pts were exacerbation-free throughout the SIROCCO and CALIMA trials, whereas about half of pts in the PBO group experienced exacerbations. Fewer than one-fifth of benralizumab-treated pts experienced > 1 exacerbation during these trials, compared with almost one-third of those receiving PBO. By increasing ptsʼ likelihood of remaining exacerbation-free, benralizumab improves asthma control, lessens exacerbation-related loss of lung function, and reduces OCS exposure. Increasing exacerbation-free days could also decrease disease-related disruptions in ptsʼ daily activities and potentially reduce health care costs associated with ED visits and hospitalizations.